Biomedical Engineering Career Careers in the United States

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BIOMEDICAL TECHNICIAN

BIOMEDICAL TECHNICIAN We are seeking a Biomedical Technician II for a healthcare facility in the Chicago Metropolitan Area, IL area. As a Biomedical Technician you will repair, calibrate, and maintain medical equipment and instrumentation, such as patient monitors, electrocardiographs, blood-gas analyzers, defibrillators, electro surgical units, anesthesia apparatus, pacemakers, blood-pressure transducers, diathermy equipment, patient care computers, and other related technical devices used in healthcare field. Responds to service calls to perform repair/preventative maintenance on biomedical equipment, while ensuring a safe operation and effective performance of medical equipment by conducting approved programs for quality control and assurance. Maintain operation knowledge of medical devices, measuring devices, and knowledge of manufacturer?s repair manuals, troubleshooting techniques, and preventive-maintenance schedules. Documents repair action and submit reports/paperwork in a timely manor. Ensure proper care of tools and other related and assigned equipment, and share on-call responsibilities. Demonstrate and explain correct operation of equipment to medical personnel. BIOMEDICAL TECHNICIAN...

Senior Mechanical Engineer / Biomedical Engineer

Senior Mechanical Engineer / Biomedical Engineer The engineer will be expected to evaluate existing products and provide design changes that improve manufacturability, quality, reliability, and reduce cost. The engineer will need to work effectively with our client Neuromodulation Manufacturing, Supply Management, Quality, Reliability, and Regulatory functions to qualify and implement design changes. Responsibilities : Perform detailed design analysis on critical design elements Provide design continuation engineering support for Neuromodulation Implantable Neuro System and implantable drug pump devices, used for movement disorder, gastro uro and pain therapies. Projects require the ability to support design changes that are mechanical in nature. The key at being successful in this job is the ability to multi-task, work effectively cross functionally, drive projects to closure within specified timelines and be flexible on project assignments. Participate, support or potentially lead corrective action teams to resolve quality issues (CAPA process....

Director, Biomedical Engineering

Category: Management/Executive Facility: Sidney & Lois Eskenazi Hospital Department: Biomedical Engineering Shift: Days Hours: 7:00 - 3:30 JOB SUMMARY: Eskenazi Health is seeking an innovative leader to fill its Director of Biomedical Engineering position! The successful candidate will coordinate activities, give direction to personnel within the department and serve as a consultant on medical equipment matters. The Director, Biomedical Engineering will be responsible for the following job functions: Responsible for the applications and adherence of personnel to hospital and departmental policies. Conducts/reviews personnel evaluations; ultimate responsibility for hire, discharge and discipline of personnel. Delegates work projects to department personnel for two distinct work areas (medical equipment repair and radiation equipment repair). Supervises new project and equipment evaluations; may include writing specifications designed to make recommendations regarding both new and replacement equipment. Evaluates potential equipment purchases to determine utilization and value; may include organization cost of feasibility studies with proper documentation to facilitate recommendations. Provides consultative service for researchers upon request. Assists in collection /verification of research data. Makes recommendations to management; explains and instructs medical staff with regard to selection and use of equipment. Serves as liaison between medical staff with regard to selection and use of equipment. Responsible for overall in-service education programs for medical staff relative to medical equipment. Develops annual departmental budget....

BIOMEDICAL REPAIR TECHNICIAN II

Job Description: BMET II - Santa Fe, NM Crothall Healthcare ,a division of Compass Group North America, provides customer focused support services. As specialists, we perform services including healthcare housekeeping, management in laundry processing, patient transportation, business facilities management and clinical engineering. Crothall is a compilation of the most committed and talented individuals working in the industry today. Our dedication to quality, exceptional customer service, and unequivocal results allow us to provide the best outcomes to our clients. And, as a member of Compass Group North America, we want you to be as great as you can be. We empower our associates to direct their own future, keeping them confident that we support them every step of the way. As a result, our associates embody greatness through their actions, natural passion for quality, and a can-do attitude. Generous compensation, flexible benefits package, intense training, unrivaled career opportunities, and a shared passion for quality attract the best people to Crothall Healthcare . The opportunity for greatness is real at Crothall Healthcare, and throughout the Compass world. If you are looking for a rewarding career where you can make a difference, Crothall is the place for you. We are looking for energetic, passionate and career minded people to join our team and help grow our business. This is a GREAT OPPORTUNITY to become a leader in a great company and growing corporation. In this position you will be responsible for providing Biomedical engineering, service and repairs on high end Laboratory Equipment on site at a hospital, including preventive maintenance, and calibrations. Responsibilities: Perform complex repairs and calibration services on a broad range of patient care and support equipment. Perform planned maintenance and electrical safety inspections on range of patient care and selected support equipment in compliance with established standards. Texas Fire Alarm License required Manage equipment and schedule service. Perform pre-acceptance inspections and develop PM procedures on newly purchased equipment; maintain files on procedures and manuals. Ensure test equipment is working properly and calibrated within established intervals. Research and initiate orders for repair parts. Provide informal training to equipment users. Participate in the Quality Improvement/Risk Management program and make recommendations for improvement. Provide emergency on-call responsibilities as needed....

Biomedical Engineering Technician Associate (BMET)

About JLL JLL (NYSE: JLL) isa professional services and investment management firm offering specializedreal estate services to clients seeking increased value by owning, occupyingand investing in real estate. With annual fee revenue of $4.0 billion and grossrevenue of $4.5 billion, JLL has more than 200 corporate offices, operates in75 countries and has a global workforce of approximately 53,000. Onbehalf of its clients, the firm provides management and real estate outsourcingservices for a property portfolio of 3.0 billion square feet, or 280.0 millionsquare meters, and completed $99.0 billion in sales, acquisitions and financetransactions in 2013. Its investment management business, LaSalle InvestmentManagement, has $50.0 billion of real estate assets under management. JLL isthe brand name, and a registered trademark, of Jones Lang LaSalle Incorporated.For further information, visit www.jll.com . GENERAL SUMMARY Repairs,installs and performs various preventative maintenance, performance assurance,inspection and calibration of biomedical equipment and systems. Equipment mustbe repaired and put back in service with minimum downtime. PRIMARYDUTIES AND ACCOUNTABILITIES Assists BMETs in repairs/corrective maintenance of electronics,electrical, and mechanical equipment, installations, and inspections of variousmedical equipment. Repairsequipment, devices and systems in a timely and quality manner to assureequipment readiness for department use. Performs preventative maintenance, calibration andperformance assurance on specific types of medical equipment and systems. Adherence to scheduled maintenance schedule toallow for optimum use and dependability of equipment by employees and medicalstaff in a safe environment for patients. Assures that required PM?s aredone in compliance with established JobPlans and both CMS and TJCstandards Helps to maintain an adequate parts inventory. Consults catalogs and manuals andrequisitions items. Models the behaviors embodied in our Mission andValues. Takesresponsibility for constructively confronting and resolving problems. Participates in open communication andteamwork activities. Delivers oncommitments in a high quality and timely fashion. Demonstrates pride in the organization. Consistent with the theme of teamwork, performs other dutiesas requested or assigned. Maintains and contributes to a safe workenvironment. Uses tools and equipment appropriately....

Biomedical Electronics Tech TEMP

In accordance with the mission and philosophy of Dignity Health, the Biomedical Electronics Technician is a professional electronics technician who provides the skills and knowledge necessary to achieve the operational goals of the Biomedical Engineering Department and Sequoia Hospital. The Biomedical Electronics Technician provides a variety of technical equipment maintenance skills including preventive maintenance and repair of diagnostic and therapeutic medical equipment and equipment systems. .A. S. Degree in Biomedical Electronics Technology, electronic technology or the equivalent with four years experience in Biomedical Engineering or completion of vocational/technical training school with four years experience in Biomedical engineering is required. A.A.M.I. certification is preferred. Valid California Drivers License. Sequoia Hospital, a Dignity Health Member, is an accredited, not-for-profit community hospital providing innovative and exceptional health care for generations of Bay Area residents. In 2014, the hospital will celebrate the opening of a rebuilt, state-of-the-art medical campus, including modernized emergency services and an all-new pavilion with three floors of larger, private patient rooms. Recognized for superior and sustained clinical quality, the hospital received the 2013 America's 50 Best Hospitals Award and the 2013 Distinguished Hospital Award for Clinical Excellence from HealthGrades®, a leading provider of comprehensive information about physicians and hospitals. Sequoia's Heart and Vascular Institute is a nationally known pioneer in advanced cardiac care....

BIOMEDICAL ENGINEERING - FIELD SERVICE SPECIALIST III

To provide specialized repair (Radiology, CathLlab, CT, MRI, PET etc.) and maintenance services on Diagnostic Imaging and Biomedical Equipment. Experience: Eight years of related experience. Must have up-to-date knowledge on technological and medical advances. Must have up-to-date understanding of The Joint Commission, CMS, 21 CFR, MDE and NFPA regulations....

Prin Human Factors Scientist

Position Description In this position, you will apply your knowledge of human performance and human factors techniques to the design and development of products offered by Medtronic Cardiac Rhythm Disease Management (CRDM). You will need a solid understanding of the theories, principles, and data associated with human performance capabilities and limitations (perceptual, cognitive, motor, bio-mechanical, and anthropometric) and the ability to apply this knowledge to the design, definition, evaluation, launch, and use of products across the range of CRDM products. Specific activities include: ? Provide Human Factors support across the product lifecycle including customer and user needs identification, development of user and workplace profiles and usage scenarios, task analysis, requirements specification, generation of hardware and software design concepts (creation of physical models and prototypes, graphical user interfaces, and product graphics), user interface design, usability testing, user error analysis, and post-launch outcomes analysis. ? Performance of these within the constraints of a complex regulated environment; and in partnership with engineering (Software, Firmware, Hardware, Mechanical, and Systems), research, technology, product planning, clinical, regulatory, and marketing groups. ? Additional tasks include standards development, in-house training and popularizing of HF role. (But little selling, HF is already widely accepted as a key technology at Medtronic.) CRDM seeks candidates who will meet our customers? expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action. Position Responsibilities ? Lead Human Factors activities across the product lifecycle including customer and user needs identification, development of user and workplace profiles and usage scenarios, task analysis, requirements specification, generation of hardware and software design concepts (creation of physical models and prototypes, graphical user interfaces, and product graphics), user interface design, usability testing, user error analysis, and post-launch outcomes analysis. Responsible for human factors activities across Medtronic?s product range including identifying, planning, monitoring, and executing tasks for entire project. ? Translate requirements into interaction/interface design solution concepts. ? Work closely with marketing, product planning, engineering, manufacturing, and regulatory to produce customer focused designs that not only meet user needs but also factor in business priorities and platform, architecture, and manufacturing constraints. ? Develop (physical and interaction) design solutions to complex, system-wide usability problems that require ingenuity and creativity. ? Direct the development of physical mock-ups and interactive prototypes of design concepts. ? Plan and conduct end user evaluations of product concepts, analyze data, document evaluation methods and results; and present design recommendations to the product team. ? Use appropriate Human Factors techniques to work with end users to determine end user behavior, preferences, and usage models and integrate these into design concepts. ? Prepare clear and effective oral and written reports of current status, progress and status of project, as required by project or department management. ? Represent the Human Factors group through various capacities including: task planning and execution, leadership, expert guidance, and education. ? Interact professionally at all levels throughout the company and with consultants and customers. Comply with applicable Corporate and departmental policies. ? Provide oversight and collaborate with consulting firms to execute human factors activities on projects. ? Maintain technical knowledge current with advancing technology related to CRDM products and associated accessories. Complete required training and certifications....

Mechanical Design Engineer

Mechanical Design-Mechanical Engineering-Auto Cad-Manufacturing-Heat Transfer-Fluid Flow-Hydraulics A suburban Pittsburgh, Pa manufacturing company is searching for a Mechanical Design Engineer to assist in the research and development of the mechanical aspect of a new line of biomedical machinery, as well working with the existing product line. This Mechanical Engineer must be able to apply engineering principles to detailed design and solve problems int he manufacturing process. They will interface with other engineers and designers as well technicians and customers. They have just purchased and are using the most state of the art Auto Cad products in 3-D,...

Engineer- Medical Device

Seeking ENGINEERS in the MEDICAL DEVICE Industry Multiple positions for the following: Quality Engineer Project Engineer Industrial Engineer Operations Engineer Jr. Engineer...

Product Manager - Materials Science

Manage Biomedical Materials product line within the Aldrich Materials Science initiative. This product line comprises a broad range of application-specific materials and tools for synthesis, characterization as well as biomedical device fabrication, addressing research, applied and commercial markets. The Biomedical Materials product line consists of materials for biomedical applications including monomers, synthetic & natural polymers, dendrimers, and polymerization initiators & additives. The successful candidate will manage the product portfolio, perform market analysis, promote awareness of the product lines, maintain the products and optimize pricing in order to meet revenue objectives for the product lines and for the Materials Science Initiative. Additionally, the candidate is expected to support team efforts as assigned in order to meet department, business unit, and company objectives. ?Market Analysis & Product Portfolio Management oPerform market research and understand competing products, technologies and competitor landscape. oAssess innovative products and technologies through consultation with scientific experts from academic, industrial, and commercial markets. oSelect focus areas for the development of new products in assigned product lines to enable materials science customers to do innovative research. oWork with R&D team and external partners to develop and extend the assigned product lines ?Product Promotion and Awareness oDevelop and execute marketing campaigns to raise customer awareness and boost sales of the assigned product lines and Aldrich Materials Science. oLead concept and technical content development for marketing pieces, including web content enrichment, print and online advertisements and the Aldrich Material MattersTM journal. oAnalyze and track promotional effectiveness and ensure promotions are delivered on time, within budget, and maximize return on investment. oGrow the materials science customer community by generating qualified leads through engagement leading scientists and participation in Materials Science conferences and trade shows. oWork with different business units to contribute to their offers and also drive sales of the assigned product lines in the different business units. oTrain sales managers globally to raise awareness of the assigned product lines, upcoming product launches and promotions. ?Product Pricing & Stewardship oWork with R&D, vendors, quality control, and product stewardship to create product development plans and lead new product development projects. oEstablish market quantities and pricing of products. oTrack progress of development projects and make appropriate decisions regarding necessary changes to technical specifications and launch schedules. oDevelop pricing strategies, discount guidelines, and perform operational pricing activities. oProvide technical feedback and help train technical services, quality control, and other support personnel in the aspects of product performance and testing specific to the assigned product line/s. ?Miscellaneous duties and tasks as assigned. ?Exemplary attendance and adherence to schedule....

Field Service Engineer

Field Service Engineer Southern Biomedical Inc. , exclusive service provider for Leica Microsystems specimen preparation equipment in Florida, has an immediate opening for a Field Service Engineer. This is a rare opportunity to join the ever growing and advanced field of Biomedical Engineering repair. Service Engineer duties include Preventive Maintenance and repair of Leica?s full line of state of the art Histology equipment, including manual and automated Microtomes, Cryostats, Tissue Processors, Embedding Centers, Slide Stainers, Coverslippers and Slide/Cassette printers In-depth factory and on-site training will be provided The FSE will travel from their home to various customer locations throughout Central and North Florida with an occasional overnight stay Factory training will be provided in Chicago...

Field Service Engineer Anesthesia Specialist -

Organizational Overview Founded in Denver in 1967, HSS has grown to become America?s leading sourcing company, providing technical and professional service programs to customers nationwide. We customize our service programs to each customer?s needs, culture, and desired outcomes. HSS works closely with customers to enhance the value of their business. We offer smarter solutions, become integral members of their team, and devote ourselves to creating great customer experiences. This business approach has earned HSS one of the highest customer retention rates in the industry. Our commitment to good employee communication, fair wages and benefits, and career advancement opportunity through education and training, also gives us one of the highest employee retention rates in the industry. We offer specialized expertise to customers in select markets. HSS services include healthcare/hospital security, aviation/airport security, government security, biomedical equipment management, security systems integration, and temporary healthcare staffing. Position Summary: The goal of the Field Service Engineer is to provide excellent equipment repair and customer support for HSS customers and their mission. This position completes repair service work, and preventative maintenance on equipment in accordance with established HSS policies and procedures. Works with a high degree of autonomy and provides a high level of customer service. The HSS Medical Equipment Management (MEM) team supports numerous nationally & internationally renowned health care facilities. Our MEM Field Service Engineers demonstrate our 8 Pillars of Success in all of their customer interactions. Those pillars are: Service, Image, Reward, Advocacy, Training, Team, Benefits, and Advancement. Essential Duties and Responsibilities: ?Performs service work and maintenance of medical equipment and ensures completion of the percentage requested by manager. ?Resolves issues pertaining to the medical equipment and works with other shop staff to ensure equipment and technology is working within specifications. ?Accurately documents and keeps detailed records of all work related activities as specified by manager. ?Performs scheduled inspections and testing as asked. ?Provides support of the equipment repair process such as following up on customer questions, attending meetings, support of field service engineers, and research issues. ?Perform repetitive job tasks required in the servicing and remanufacturing of equipment. ?Provides all other support as requested by manager. ?Cleaning and preparing parts and assemblies for replacement. ?Works and interacts with current and prospective clients, other employees, sales representatives, vendors, medical personnel, guests, and visitors. ?Work with equipment to meet regulatory requirements. ?Teach and train personnel on the steps and process of repair, maintenance ?Oversee and qualify work of other shop employees as required by the manager ?Other duties as assigned....

Engineer/Scientist

Great Opportunity! Let's talk! Give me a call or email. Engineer I position in the Materials Engineering group. MS in Chemical Engineering, Biomedical Engineering, or Biochemistry who has experience working with medical device development. The ideal candidate would also have experience working with blood. Primary responsiblities: Assist in R&D with conducting in-house studies. Running blood collection procedures. Collecting blood samples. Testing blood samples including conducting bioassays and independently operating various standard analytical instruments. Collecting and recording expermential data Monitoring the functionality and maintenance of the instruments and lab supplies. Specific skills and education: BS in Life Science or related field, Biochemistry 0-3 years lab environment Hands-on experience working with blood preferred Experience with blood sampling, preparation for analytical testing, blood storage practices. Experience in Good Laboratories Practices, Quality Control protocols and Safety Procedures....

Vice President of Operations

RESPONSIBILITIES: Engineering & Design Lead the Engineering and Design teams: Custom project engineers, standard product engineer, automation & process control engineers and CAD designers. Troubleshoot design challenges with staff and work with them to identify cost-effective and schedule-compliant solutions. Manage progress on ten to thirty concurrent projects ensuring major project milestones are achieved on schedule and communicating to management, sales or the customer when schedule risks arise. Ensure product compliance with customer requirements while ensuring project boundaries are respected. Ensure product compliance with international, national, regional and local requirements. Actively manage cost-saving efforts through supply chain development and efficiency gains. Engage directly with customers to clarify design requirements, gain approval of drawings, data sheets and other project-related design issues while constructively resisting project scope expansion. Engage design foresight into day-to-day operational process. Lead the electrical design of built-to-order electrical control panels, including PLCs, I/O, VFDs, motor starters and solenoid valves. Lead the PLC/HMI-SCADA automation team. Support the R&D efforts by allowing access to design resources. Support the Sales and Marketing efforts by interpreting customer requirements, advising sales on exceptions, schedule limitations, resource constraints and capabilities. Supply Chain Supervise the plant buyer. Oversee the supplier qualification process. Negotiate with suppliers on price, schedule and commercial terms. Minimize risk of over-reliance on a single supplier for critical components. Ensure technological advancements within our supply chain are leveraged in our products and communicated to sales/marketing. Production Lead a team of product assemblers and incoming quality inspection/receiving. Manage the flow of work-in-process through the facility. Ensure appropriate reviews are performed at key assembly milestones to prevent downstream re-work efforts and quality deficiencies. ADDITIONAL RESPONSIBILITIES: Perform essential duties with constant respect for ISO9001 procedures, safe work environment, OSHA requirements and company policy guidelines. Take initiative to resolve issues before they escalate. Occasional domestic & international travel REQUIREMENTS : Bachelor?s degree in Engineering (Chemical, Electrical, Mechanical, or BioMedical). Advanced engineering and/or MBA a plus. PE or PMP certification highly desirable. 10+ years? experience working with SS process equipment, especially in or for pharmaceutical or biopharmaceutical applications such as chromatography and filtration. Familiarity with pumps, valves, instrumentation, fittings, analytical measurement devices up to 2? line. Thorough understanding of compliance issues relating to the majority of the following: OSHA/ANSI Machinery Safety, ASME BPE, ASME Section VIII, UL, Hazardous Areas, CE, EU Machinery Directive, EU Low Voltage Directive, EU Pressure Equipment Directive, cGMP, GAMP and other applicable standards. 5+ years? supervisory leadership experience over multiple departments and engineering team. Demonstrated proficiency negotiating directly with customers and suppliers. 5+ years? experience designing equipment for cGMP manufacturing and other documentary procedures. Familiarity with GAMP documentation requirements....

Director, Facilities Management & Engineering Services

Mercy Hospital & Medical Center, we have a rich history of providing the most advanced medical care in the Chicago area. Here, you'll find world-class medicine combined with compassion and convenience. As Chicago's first hospital, Mercy has a tradition of leadership and innovation that we invite you to share. Under the supervision of the Vice President, Support Services, the Director of Facilities and Engineering consults with Executive Management regarding the physical needs of the hospital. Responsible for planning, coordinating, and directing the activities of the Facilities Management and Engineering Department. Oversees Facilities Construction, Facilities Maintenance, Buildings and Grounds, Biomedical Engineering, Project Management, Planning and Design. Directs all Facilities Management and Engineering Department employees. Responsible for establishing cost and operating budgets, facilities compliance, consults with departments, outside contractors, and vendors concerning physical requirements, and prepares necessary associated budgets. Approves and oversees purchase of products and equipment, as well as maintenance contracts for subordinate departments....

Senior Engineer, New Product Development

TITLE : Senior Engineer, New Product Development Department: New Product Development Classification: Exempt Reports To: Manager/Director of New Product Development Date: April 28, 2014 Symmetry Medical is an Equal Opportunity Employer. 41 CFR 60-1.41 (a) JOB SUMMARY: The Senior Engineer will be responsible for the product design and development aspects of a complex project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. This position is expected to develop an expert knowledge of products and will assist in providing product support to the field as required. This is accomplished by maintaining Symmetry Medical?s principles of Safety, Quality, Customer Satisfaction and Innovations. ESSENTIAL FUNCTIONS: Lead cross functional project teams through all phases of the product development process including planning and product launch. Lead all aspects of the project management functions including scope definition, budgeting, and contingency planning Work closely with project core team (marketing, manufacturing, quality, testing etc) and surgeons to define user needs, generate design concepts and prototypes, and perform design evaluations (such as tolerance analysis, FEA, DOE, simulated use testing etc). Support development of product process validation plans and testing. Collaborate with manufacturing engineering and suppliers to optimize designs for manufacturability and produce prototypes. KNOWLEDGE, SKILLS, AND ABILITIES: Medical device industry Project Management Three-Dimensional Parametric Solid Modeling FDA QSR and ISO 13485 quality standards Quality standards within the company Scheduling work to achieve goals Customer focused environment Business systems and knowledge of impact to business Strong organizational skills Strong people and leadership skills Diplomacy Motivation Teaching/Coaching/Mentoring Excellent verbal, written and presentation skills required. Problem solving and evaluation Process improvements Computer operation; Proficiency in MS Office Suite Project management Streamlining processes Self Motivated Multi-task Speak in front of people in a variety of settings Be flexible and adapt to changes in the market place Interface professionally and courteously with customers/public/internal staff Prioritize work Meet goals and objectives set for department and company Keep current in changing work methods and regulatory changes EDUCATION AND WORK EXPERIENCE A minimum of a BA/BS in Engineering plus 6 years of experience or an MS degree in Engineering plus 4 years of experience is required. Advanced degree is preferred. A degree in Biomedical Engineering or Mechanical Engineering would be preferred. Experience with medical device development is strongly preferred. Previous experience in new product development is required. Must have experience in identifying user needs, device design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required. Demonstrated understanding of various types of mechanisms, materials, proper tolerancing, drafting standards, design for mold ability and GD&T are required. Demonstrated background in developing creative solutions to solve design problems. Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively. Must have experience leading and influencing others without authority, participating on cross functional teams and solid negotiating skills to bring products from concept to launch is required. Must have experience communicating concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams, and work effectively as a project leader. Experience utilizing computer aided design (CAD) to develop a product is required Process experience/six sigma training preferred. PHYSICAL AND ENVIRONMENTAL DEMANDS: Very frequent ? 20 + hours per week: Office environment Production floor Walking Hand dexterity - keyboarding Sight Talking Frequent ? 8 to 20 hours per week: Working overtime Occasionally: Lifting 25 pounds TRAVEL REQUIREMENTS: X YES NO Yes, may require up to 10% travel. INTENT AND FUNCTION OF JOB DESCRIPTIONS: Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all inclusive. In accordance with Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization. Job descriptions are not intended as and do not create employment contracts. This organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law....

Medical Device Design Engineer / R&D Engineer

Engineer Today, Manager Tomorrow *** Positions in Harrisburg and King of Prussia, PA **** A very good client of ours is searching for several Product Development Engineers. Candidates ranging from Junior to Principal levels should apply. This is with a pioneering medical device company. The ideal candidates will have a background in Mechanical Engineering. This is a ?hands on? position that involves ?concept to manufacturing? work. Mechanical Engineers with the innovation and work ethic have an excellent chance for advancement as the company continues to expand. Please do not hesitate to apply. - BS, MS, PhD ? Mechanical Engineer or Biomedical Engineer - 2 -10 years of medical device experience - Concept to Manufacturing - Innovative, fast moving company - SolidWorks, FEA, GD&T, Fluid Dynamics...

Manufacturing Engineer / Automation Engineer

Manufacturing Engineer ? Medical Device *3rd PARTY RECRUITER - CONFIDENTIAL My client is looking for several top Senior Manufacturing Engineers (2-10 years exp) with a Mechanical Engineer, Biomedical Engineering, or Electrical Engineering degree. This is a strong player in the Medical Device industry looking to bring their new products to market through added manufacturing and increased product lines. They are looking for a strong mechanical aptitude as well as a commanding technical knowledge. This position will be requiring ?concept to manufacturing;" demanding innovative problem solving ability. They need everything from TOP BS/MS degree students to several years experience in design of intricate, complex component devices. The candidate will be need hands on" ability and experience with the verification and validation of product designs. They are looking for management ready applicants; provided their continuous expansion and opportunity to move up. Salary is among Industry Elite; along with a TIER 1 benefits package/ Relocation Assistance...

Data Engineer

Data Engineer The Data Engineer is responsible for the following: Oversee data integration for custom development engagements setting code standards for others, and conducting code reviews Monitor processes that perform data transformations and communication protocols for correctness and compliance with SLAs Assess technical complexity, risks, and costs during a new client engagement Ensure data confidentiality and implement procedure to protect against accidental disclosure Serve as key technical contributor to critical projects that involve complex data integration Provide clear communication and documentation to stakeholders Create automation tools in Java Scrip and Python and documentation to streamline analyst-driven data management practices Comfortable with ETL Operations while working closing with client facing business analysts and other software engineers You?ll want to come to work because in this role you get to: Help build open-source tools to advance open science Help accelerate discovery in cutting edge biomedical research Use efficient technologies like Python and HTSQL Use modern agile development practices Work with smart, decent people deeply engaged in their work Help an exciting small company grow to its potential...

Pharmaceutical Manufacturing Process Engineer

PHARMACEUITCAL MANUFACTURE PROCESS ENGINEER REQUIREMENT #14-00832 RECRUITER: BRIDGET BURNS JOB LOCATION: DEVENS, MA AUGUST 8, 2014 Project Description: The client in Devens, MA MS&T organization is seeking to fill a Process Engineer position for a 1+ year contract. The successful candidate will provide significant contributions toward technology transfer and process validation activities. The successful candidate will have a demonstrated background in bioprocessing (upstream and/or downstream), experience troubleshooting manufacturing processes and strong technical documentation skills (memos, protocols, reports). Responsibilities: - Work independently to provide support on upstream/downstream facility fit, process technology transfer and process validation. Provide process troubleshooting during scale-up and engineering runs. Provide process subject matter expertise and ownership of assigned deliverables to further the project objectives. - Lead cross-functional meetings and professionally represent the MS&T department. - The successful candidate will work effectively in highly cross-functional project teams, matrix management environments and working independently to accomplish project goals. - The position will interface with Manufacturing, Quality, Engineering, and internal MS&T departments at multiple sites throughout the BMS network - Strong communication and technical writing skills are required. Qualifications: - B.S./M.S. in Chemical Engineer, Biochemical Engineer, Biomedical Engineer, Biochemistry or related field (Advanced degree is preferred) - Prior experience (2-5 years) in process development, process validation or manufacturing support in bioprocessing (upstream and/or downstream) - Experience with statistical methodologies, cGMP regulations, and regulatory requirements are a plus. This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget:...

Software Integration Engineer

RESPONSIBILITIES: Our client is seeking a Biomedical Software Integration Engineer in Cambridge, Massachusetts (MA). This is a great opportunity for a full time position with this company. This position is required to/ responsible for: Coordinate releases/deployments across several organizations in a HIPAA regulated environment Act as an escalation point for troubleshooting an all-encompassing range of production issues Continue to add to documentation for best practices and procedures Manage and monitor a robust network for a very advanced application suite...

Laboratory Technician

Laboratory Technician Immucor is seeking a Laboratory Technician to join our team. We play a vital role in making blood transfusions safe for patients world-wide by providing blood banks with products and services that drive efficiency and productivity. A vital team member the Laboratory Technician performs a variety of technical and administrative tasks associated with the Systems Engineering Laboratories. Our ideal candidate will have CBET, CLES, CLA or MLT certification with good organization skills and strong problem solving abilities. Job Responsibilities As a Laboratory Technician you will be responsible for performing routine and preventative maintenance on all Automated Instrumentation in the R&D Labs. You will also maintain and order department supplies and raw materials for R&D labs including stocking supplies and performing cycle counts. Additional responsibilities: Repairing and replacing parts as necessary on all Automated Instrumentation in R&D labs Maintaining and ordering department supplies and raw materials for R&D labs including stocking supplies and performing cycle counts Assuring all record keeping is in accordance with Departmental and Organizational procedures Assuring all personnel are in compliance with all departmental laboratory procedures, OSHA safety regulations and other safety related procedures Maintaining a clean and organized working lab environment...

Mechanical Engineering Laboratory Technician

Mechanical Quality Technician- Medical Device- North Haven, CT. Kelly Services is hiring a Quality Technician with emphasis on conducting manual testing on Medical Devices for a long term (18 month) contract position working with an industry leading company located in North Haven, CT. This job is forty hours a week, Monday through Friday and it pays 17.00$/hr. JOB DESCRIPTION: Entry level position for Biomedical, Quality, or Mechanical Engineer Looking for eager biomedical, quality, or mechanical engineer to work on a quality assurance team assisting project analysts with medical device testing. The ideal candidate will have excellent computer and communication skills, and be comfortable with fast paced work on high priority projects. Any experience in quality, medical devices, or suture testing is helpful. Sets up, operates and maintains laboratory instruments, monitors experiments, makes observations, calculates and records results, and often develops conclusions. Individual is familiar with basic scientific principles and has had some laboratory experience. Can follow written direction and maintain a laboratory notebook. Has good communication skills and is computer literate. Special project - mostly suture testing. Open position: General DQA various medical device testing. Position title: DQA Lab Tech I Job description: Assisting the DQA project analysts with medical device testing. Qualifications: Bachelor's degree in an Engineering discipline, specifically Mechanical Engineering or Biomedical Engineering degree is highly preferred 1-3 years of Quality, Mechanical or product testing is also acceptable ability to take measurements, follow detailed instructions, log data electronically experience doing DQA testing on equipment is preferred experience running quality testing, following test procedures. Please apply by selecting the apply now button on this posting. If necessary you may email the remotely based recruiter directly at: About Kelly Services ® Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion. [Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ? , a free career and employment resource iPad® app by Kelly Services.] iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Since employing its first engineer in 1965, the Kelly engineering specialty has grown to be recognized as a leading provider of engineering resources to customers in such industries as automotive, chemical, defense, electronics, energy, medical device and pharmaceutical. Want more information? Visit kellyservices.com/engineering Connect with us on...

Electronic Hardware/Engineer

Volt has an exciting full-time opportunity in Bellevue, WA for an Electronics/Hardware Engineer . The ideal candidate will be responsible for the development of mixed signal systems, engineering boards, circuit design, simulation and testing, PCB layout, production and validation, biomedical electronics, device level audio circuits, analog signal acquisition systems or sensors, or related fields. If you have on-the-job experience in the following areas, please apply ASAP! Semiconductor devices Analog/RF circuits Biomedical electronics Device level audio circuits Analog signal acquisition systems or sensors, or related fields This is a Direct Hire position in Bellevue, WA and is offered through Volt Workforce Solutions - Northwest Engineering . We are among the largest Staffing Companies in the US for contingent/temporary and direct hire placements, and support many of the top rated Pacific Northwest companies....

Area Vice President

The Area Vice President of the West Region oversees clinical engineering services across multiple hospital sites, with multiple customers across the United States. The Area Vice President is fully responsible for profit and loss, integrated service delivery model, customer retention, associate development, strategic development and leadership initiatives designed to meet the TriMedx goal of being the most trusted service partner in healthcare....

Sr. Mechanical Engineer

SR./STAFF MECHANICAL ENGINEER - MEDICAL DEVICES Do you: Want to work on technical challenging projects? Crave the opportunity to learn new things? Want to have control over what direction your career turns? Then you should work at Moog, Inc. - a global organization that operates in 23 countries. Our expertise lies in applying advanced technologies to the precision control of motion and fluids. Underlying this expertise is a set of values and beliefs that guides our actions: we pride ourselves on solving challenging problems that make a difference; we strive to be flexible to our customers? unique needs; we do what we say we?ll do; and we believe close working relationships provide better results. We are the Medical Devices Group who designs, manufactures, and distributes industry-leading enteral feeding, infusion, and post-operative pain management pumps, fluid sensing and control solutions, and surgical hand pieces. We have a current openings for a Mechanical Engineer who has a BS/MS in Mechanical/Biomedical Engineering, and at least 7 years of experience Our culture is based striving for mutual trust and respect, and we hire capable people and let them do their jobs. This position is located in Salt Lake City, Utah . Sound good? Here?s the details: Core Responsibilities: Reporting to the Site Engineering Manager, this position is responsible to ensure the highest possible professional standards and integrity are maintained in the development of electromechanical medical devices. Responsible for developing products within a regulated framework. This involves defining tasks and objectives and ensuring the most efficient use of company resources to meet these goals. This position will also ensure all project-related documentation; including writing test and assembly procedures and initiating Engineering Change Orders (ECO?s) are completed timely and accurately. Project Management ? Serves as engineering team member for the disposable sets portion of related enteral and intravenous pump design and development projects. ? Conducts feasibility studies, identifies engineering tasks and cost estimates, identify technical risks and mitigations ? Establishes and maintains schedules for own deliverables, including tasks and completion milestones. ? Ensure that product development goals are met. ? Confers with supervisor and/or technical leads on unusual matters, reports at regular interval to project leaders on activities/problems/plans ? Time and project management with the ability to manage multiple priorities. ? Works effectively with designers at contracted companies and affiliated organizations ? Works effectively with designers at contracted companies and affiliated organizations. Technical ? Document and review designs using the established development process, including but not limited to high level design, design specifications, design verification, test specifications, and traceability. ? Work with mechanical, software, and manufacturing teams to reach consensus on difficult system-level tradeoffs. ? System Integration ? Problem Solving and Innovation - Provides root cause analysis and design solutions for system level issues. ? Determines and implements the closure of specific corrective actions. ? Involved with device safety and hazard analysis activities. ? Ensure and create as needed, engineering processes, practices to ensure compliance with various standards and regulatory requirements. Work with technicians in evaluating and testing concepts. ? Monitor technology trends such as emerging standards for new technology opportunities. What talents and abilities you will bring with you? ? BS/MS in Mechanical or Biomedical Engineering ? Minimum of 9 years related experience. ? Understanding of concept-to-production engineering, including high level design, detailed design, prototype assembly logistics, lab debugging, system integration, design verification, and manufacturing handoff. ? Complete understanding of technical principle, theories, and concepts in the field of engineering. ? Independently determines and develops approach to solutions. ? Excellent communication skills, written and verbal, enthusiastic, motivated and self-driven. Benefits: Moog Medical Devices Group offers a wide range of benefits, including, comprehensive medical and dental insurance at competitive rates, life insurance, short and long term disability insurances, 401(k) plan with a company match, generous paid time off policy for work life balance, and the opportunity to work in a team environment. How to Apply: If you are interested in joining a team of passionate engineers, and have what it takes to make a positive impact in the lives of the patients we serve, submit your resume via the Moog online Career Center located at: www.moog.com . The requisition number for this position is: 14-10686 EOE/AA Minority/Female/Disability/Veteran #CB...

Engineering Sales Support Program Project Manager

Empirical Testing Corp . www.empiricaltesting.com was founded in 1998, and located in Colorado Springs Colorado, is the global leader in orthopaedic device testing and holds A2LA accreditation for the largest number of medical device testing methods in the United States. Due to our continued profitable growth we are adding a new additional position of Engineering Sales Support Program Project Manager. The role of our Engineering Sales Support Program Project Manager is to help our US and global clients, who are entrepreneurial surgeons, start-ups and medical device companies, to achieve Food and Drug Administration (FDA) approval of their orthopaedic implantable devices. This position combines the roles of project manager and technical advisor between our customers and our test engineering staff to ensure that customer goals and expectations are managed and achieved. This partnership is accomplished through monitoring and communicating project milestones and parameters regarding quality, timelines, technical requirements, engineering capabilities, regulatory and project cost parameters which will have been agreed to with technical staff and the customer. Ping pong, darts and air hockey playing skills are a plus as we have a pretty competitive lunch time round-robin going on. The Engineering Sales Support Program Project Manager interfaces with our engineers who handle projects from start to finish with our clients in testing criteria definition to meet ASTM standards, CAD design of fixturing, interface with in-house machine shop manufacturing of fixtures, test frame selection, partner with lab support technicians on test specimen machine loads, data collection and reduction as well as technical report writing. As holder of the A2LA's ISO/IEC 17025:2005 test laboratory accreditation certification, ETC is recognized as capable and qualified to perform testing and evaluation of orthopaedic devices in compliance with ASTM/ISO guidelines in the area of finished medical devices. We have a 24-hour operation, with lights out operations during second shift, third shift and weekends. What We Do. Our employees are committed to providing the highest quality professional testing services for our customers, including accurate and reliable testing results, professional technical reporting, and a rapid response to any issues that arise. Above all, our services are designed to be sensitive to a fast paced product development environment and are delivered at a competitive price. Quality Assurance and Confidentiality Empirical Testing Corp. is committed to Quality and Confidentiality. All employees must undergo training in both the QAS and confidential document handling. As a matter of course, all Empirical Testing Corp customer relationships are deemed confidential. The QAS ETC has implemented is based upon the requirements set forth by the most current version of ISO/IEC 17025. The QAS will meet or exceed these requirements and the requirements of the customers, by following ETC's established policies and procedures. This devotion to quality testing provides you with a competitive advantage by reducing costs, establishing credibility, improving efficiency, and enhancing profitability. Medical Device Testing. At every opportunity, Empirical Testing Corp. deepens its commitment to performing the highest quality medical device testing. At present, ETC holds the widest range of accredited test standards for medical devices currently available in the United States and is dedicated to continually pursuing standards as they become available. Good Laboratory Practices. By observing and utilizing Good Laboratory Practices (GLP), Empirical Testing Corp. assures integrity in lab planning, monitoring, recording and reporting. Product Development Support. Empirical Testing Corp. is equipped to respond to a fast-paced product development environment. While our extensive scope of accreditation covers a wide variety of medical devices from spine to extremities, Empirical Testing Corp. is also dedicated to development and testing of custom protocols for devices that push the envelope of existing technologies. Technical Reports. Our team of knowledgeable biomedical engineers helps execute client test plans. ETC provides a complete service package, including an unsurpassed technical report, which is second to none. Our objective is to furnish you with accurate, reliable, test reports that can be submitted to meet global regulatory requirements, including FDA and CE marketing approval. Commitment to the Profession. Our proven expertise in many biomechanical engineering disciplines, and our philosophy of continuous improvement in all that we do, enables us to be the "best in class. ?At Empirical Testing Corp., we are committed to the field of medical device testing, which means you benefit from years of specialized bio-medical engineering experience, knowledge, and insight. From the moment you engage in a partnership with Empirical Testing Corp and throughout your product development cycle, you'll receive prudent suggestions, based on our experience and your test results, for turning your medical device concept into a product that meets regulatory marketing approval. How to join our team. If you are interested in joining our team please respond with your resume, cover letter, salary history and requirements attention Sam Sargent. We offer a competitive compensation of base salary and bonus plus a competitive benefit package including medical, short term disability, dental, life, and 401K match....

Director of Facilities Engineering

DIRECTOR OF HOSPITAL PLANT OPERATIONS NEEDED! Job Description: The Director of Plant Operations is responsible for planning, organizing and implementing work assignments and projects; decision making using analysis, objectivity foresight, drive and creativity; and clinical/department specific competencies for Engineering, Security and Environmental Services and Linen and liaison to the Bio-Medical Department. Duties: 1. Develops and implements preventive maintenance plans to ensure reliable operation of physical plant and hospital equipment. 2. Evaluates equipment failures, safety issues, manpower needs and systems problems and develops a plan of action for correction or resolution. 3. Serves as Safety Officer for facility and responsible for ensuring a secure environment at the facility at all times. 4. Coordinates budget development, management, and control for Engineering, Security, and Environmental Services/Linen departments/employees. 5. Develops and negotiates contracts as necessary for business operations. Facility Information: 20 FTE's Our hospital features comprehensive inpatient and outpatient services as well as an expanded, dedicated Women's Center. Job Requirements Five years + management experience in a healthcare environment. Education required: B.S. in Engineering or Management with Masters Degree preferred. Good people skills, computer literacy for equipment and systems control. Knowledge and understanding of building, electrical, and life safety codes and their application in the healthcare industry. Knowledge and understanding of Texas Department of Health hospital licensing standards. Please reply with your resume to be considered for this wonderful healthcare opportunity! Amy Williamson Healthcare Manager MSI-Dallas Office toll free (800) 553-8268 x 3029 direct (469) 713-3029 fax (469)713-3080 MSI International (www.msi-intl.com) is a leading global recruiting firm that has been supporting the growth and success of companies and enhancing the careers of professionals since 1968. The Atlanta-based company provides direct-hire and contract professionals in these industries: Accounting, Banking, Biomedical, Construction, Distribution, Engineering, Financial Services, Food Technology, Healthcare, Information Technology, Legal, Manufacturing, and Telecommunications. Bringing Together People, Companies and Careers?...

PRODUCT DEVELOPMENT ENGINEERS

Must have Med Device experience Must have metals experience Must have a Mechanical Engineering Degree or Biomedical degree Must have design experience with Pro E or Solidworks Designs and develops new implants and instrumentation. This includes communication with surgeons and sales consultants, understanding the clinical issues, defining the design parameters to support AO philosophies, and ensuring the correct product is provided to the customer. Position Duties Include: - Designs and develops new implants and instrumentation and develops improvements and modifications to current products. - Interacts with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts. - Works directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up. - Generates product models, concept layouts, and prints using ProEngineer software. Apply geometric dimensioning and tolerancing accordingly. - Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies. This includes all Risk Management activities - Develops mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing. - Works with manufacturing during the design stages to incorporate manufacturability into the product designs. - Responsible for all the designs from concept development through product launch. - Responsible for initial patent review of designs for freedom to operate. Experience Required: - Bacheloras degree in Engineering required (BSME or Biomedical are acceptable) - Working experience with ProEngineer or Solidworks is required - Must have experience working with metals in Med Device - Experience within a product development team in the Medical Device industry is required - Familiarity with FDA Design Controls - Must have 3 to 7 yearsa experience in design and development of Medical Device products - This is a ahands ona position...

Biomed Equip Tech III B

BMET- (Biomedical Equipment Technician) certification is preferred. Candidates for this position require a combination of training, education, and experience which demonstrates a high level of proficiency in the performance of the above duties. An Associates degree in an appropriate engineering discipline required. Minimum of six years experience required Entity Main Line Services Department Biomedical Engineering Shift Weekend Requirements Salary Grade 210...

Software Engineer - DSP / Machine Learning

Software Engineer - DSP / Machine Learning needed for a long term contract opportunity for Yoh's client in Beaverton, OR. Top Skills You Should Possess: Digital Signal Processing Algorithm Development C++ / Perl What You'll Be Doing: Software Engineer - Machine Learning will identify and determine user needs and tool Software Engineer will bring insight from industry experience in application of modeling using machine learning and familiar with typical features, and signal processing to clean up and extract features from motion sensors to develop sports and fitness applications. Software Engineer - Machine Learning will collaborate in cross-functional engineering groups on product development Software Engineer - Machine Learning will join the technical project team to devise features for machine learning algorithms and general insights to a set of scalable platform requirements and tools to be developed. Develop insight on features relevant to a variety of physiological sensor applications Software Engineer - Machine Learning develop computationally efficient digital signal processing algorithms to extract features from sensor data Software Engineer - Machine Learning will develop algorithms to automate feature generation and prototype algorithms to model the data. Software Engineer - Machine Learning will prototype DSP algorithms for resource constrained platforms and real-time systems. What You Need to Bring to the Table: MINIMUM of a Master's Degree in Computer Science, EE or related subject matter MINIMUM five (5) years post-graduation experience Matlab and other data processing / visualization tools Experience in Statistical Analysis Experience with digital signal processing techniques on time sequences. Proficiency in C and/or python Bonus Points! Otherwise Known As Preferred Qualifications: Ph.D in Computer Science, EE or related subject matter Experience in processing data sequences from biomedical and inertial sensors Understanding of basic data structures and algorithms used in machine learning If This Sounds Like You, Apply Now! Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here ! Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process. J2W: ENG; J2W: INFOTECH Tax Term: CON_W2...

Systems Engineering Manager (D14-046)

About us: Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) designs, manufactures, and distributes a broad range of innovative tools and services to the life science research and clinical diagnostics markets. Throughout its existence, Bio-Rad has built strong customer relationships that advance scientific research and development efforts and support the introduction of new technology used in the growing fields of genomics, proteomics, drug discovery, food safety, medical diagnostics, and more. The Clinical Diagnostics Group develops, manufactures, sells, and supports a large portfolio of products for laboratory diagnostics. Bio-Rad is a leading specialty diagnostics company and its products are recognized as the gold standard for diabetes monitoring and quality control (QC) systems. Bio-Rad's clinical diagnostics products incorporate a broad range of technologies used to detect, identify, and quantify substances in bodily fluids and tissues. The results are used as aids to support medical diagnosis, detection, evaluation, and the monitoring and treatment of diseases and other medical conditions. We are currently seeking a Systems and Verification Engineering Manager for our Hercules, CA location. About the position: The Systems and Verification Engineering Manager will work closely with marketing to develop product requirements and work closely with other senior technical staff to identify key technical challenges and develop system architectures for IVD products. Key responsibilities include: Improve on the process for system and sub-system verification, including test automation and traceability to requirements, specifications and risk. Partake in verification and validation testing as needed. These responsibilities also apply to integration testing Perform system level modeling to determine power consumption, throughput/speed, cost, etc., for complex IVD products Perform risk analysis, compliant to relevant international standards, for products in development Some lab work with blood based in vitro diagnostics Support lifecycle activities and processes in compliance with applicable international standards and FDA guidelines Manage a group of 2-6 engineers and technical staff involved with systems analysis and testing of In-Vitro Diagnostic Instruments Manage group budgets Partner with Project Management on group schedules/timelines International and domestic travel may be required up to 10% of the time Required Skills: A successful candidate will have: At least eight years overall engineering experience, with at least five years in the medical device or diagnostics industry, or other highly regulated industry (e.g., aerospace, automotive), including one or more successful product launch BS in Electrical, Mechanical, or Biomedical Engineering. M.S. or Ph.D. is preferred direct experience in test automation, and generally improving the process of verification direct experience solving complex system engineering issues, including the interaction of the instrument, assay and consumables, and user direct experience working with marketing in the product definition stage, and continuing to the successful verification and validation of a product Excellent written and verbal communication skills Ability to work effectively with cross-functional teams Experience with the following is considered a plus: Regulatory requirements for IVD products SysML and/or UML Fluidic and electromechanical systems Experience with MATLAB/Simulink Code development in one or more of the following: C#, C, Python DOE, Statistics, and associated tools If you are a self-starter who enjoys the challenges and rewards of working in a growth-oriented, global organization, and if your background matches these qualifications, we'd love to hear from you! Bio-Rad is an EEO employer, we value diversity in our workforce and our customers...

Sr. Quality Engineer, Design Assurance

Pioneering Therapies, Transforming Lives. What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Sr. Quality Engineer to work with our innovative R&D team in Sunnyvale, CA. The Sr. Quality Engineer will work with a small, nimble product development team to create a high quality, innovative and compliant medical device. A key activity will be to develop a quality system appropriate to early phase product development which evolves as the product matures. The Senior Quality Engineer will contribute to product design by leading the team in performing design assurance activities throughout the product development process. This position will advise, review and approve design, process, and test documentation. This position requires strong communication, organizational and technical skills. This position will participate in problem solving activities and developing intellectual property Responsibilities: This position is responsible for, but not limited to, the following: Coordinates Risk Management and Quality Plan Activities Contributes to efforts to develop and validate test methods which address the User Needs and Design Specifications of the PHP device. Assists team members in developing testing strategy and performing data analysis. Works with product development team to evaluate device performance and test methods robustness. Participates in feasibility/ laboratory testing and performs failure analysis / corrective action activities in order to determine design/ test modification. Participates in cross functional activities (i.e. creating design inputs, supplier development, protocol development, process qualification)....

Quality Control Engineer

Job Title : Quality Control Engineer (QCE), I/II Department: Quality Assurance Reports to : Manager, Quality Control Primary Function of Position: The Quality Assurance department is devoted to assuring safe, reliable and effective products that exceed patient, surgeon and hospital expectations. The department plays a vital role in product and process quality supporting commercial production for all da Vinci? Surgical System product lines including system platforms, endoscopic instrumentation and supporting accessories. The Quality Control Engineer (QCE) works with a team of dedicated individuals supporting manufacturing operations to assure quality of finished product and identify quality issues related to electrical, mechanical and software subsystems. The QCE evaluates product quality issues, performs root cause analysis, identifies remedial actions and follows up to ensure all actions are completed satisfactorily prior to resolution and closure. Roles & Responsibilities Process Development ? Develops and validates quality assurance procedures, sampling plans, methods, equipment and processes ? Monitors manufacturing procedures, processes and records for compliance with established requirements ? Evaluates deviations and non-conformances and supports resolution of quality issues ? Supports process validation and verification ? Reviews and trends product and process quality issues using data analysis and root cause investigation ? Responds to quality escalations and provides technical support for troubleshooting, repair and testing ? Perform risk analysis and determines quality disposition for variance requests and non-conformances ? Represents the department cross-functionally in meetings that may include senior and external personnel ? Releases process and document changes through engineering change orders and deviations using ISI change control process ? Escalates to direct management all quality issues that could impact patient safety or surgical efficacy ? Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk ? Performs other duties as assigned by management...

Senior Staff Quality Engineer

Thought leader within Quality Engineering Team. Performs quality engineering analysis and synthesis activities in support of projects to develop new products or improve products already in production. Typically will work in small project teams where keys to success will be to respect the ideas of others while having the knowledge and experience to gain team support to ensure that quality and regulatory requirements are met as they relate to design control and change control. This person will also work with cross functional stake holders to ensure overall improvement of product reliability. Responsible for evaluating the scope of new projects, defining and planning for quality requirements; researching or consulting with QA/RA staff to define applicable regulatory and statutory requirements, Ensures that all requirements and deliverables are met during the design control process. Responsible for forming risk analysis teams and leading risk analysis activities on projects as required. The incumbent may complete some risk analyses personally, but emphasis will be on facilitating team efforts. Will generate or assist in the generation of design verification and validation protocols and reports which are clearly understood and are compliant with all applicable standards and regulations. Will have command of an appropriate set of mathematical, statistical and scientific problem solving knowledge to bring to bear on problems encountered. Will serve as a consultant on design control processes to the business to ensure project success. Verification, Qualification, Validation, Reliability, Root cause Analysis, Process mapping and analysis, Project management, depending on specific function Project Management Skills Supervisory and mentoring responsibilities as assigned...

Vehicle Safety Supervisor

Job Title: Vehicle Safety Supervisor Work Location: Costa Mesa, CA (Orange County) If you haven't heard, exciting things are happening at Fisker Automotive and Technology Group, LLC! The New Fisker is growing and looking for professionals who share our ingenuity and creativity. If you are focused on building a career with an innovative luxury brand, and think beautiful southern California could suit your lifestyle we would like to hear from you. Responsibilities for the Vehicle Safety Supervisor will include performing component level impact test and vehicle level collision safety test, develop planning specifications for safety systems, analyze test results and improve performance of safety systems. Test results and analysis to be communicated through reports, summaries and small group meetings. Scope of Work for the Vehicle Safety Supervisor: - Develop the structural crashworthiness with BIW & CAE teams and occupant dynamics analysis with considerable knowledge in FMVSS and other crash assessment tests. - Develop the test plans for impacts, OOP, sled and crash tests. - Analyze the impact, sled and crash test results along with simulation outputs. - Develop optimization of safety restraint system with team through sled and crash tests. - Prepare the test requirements for sled and crash performance. - Track the development schedule for each safety components and safety system. - Recommend design approaches and solution to technical problems directly to other teams on technical matters relating to safety restraint systems. - Communicates with managers, supervisor directly and DREs (Design Release Engineer) as required....

Electronics Tech (Medical)

Electronics Tech (Medical) UC Irvine Health Orange, CA Job ID: # 5683 Full Time, Days UC Irvine Health is an exciting place! Ranked as one of the Top 50 hospitals in the nation for the last 11 years (U.S. News & World Report), we are Orange County?s only academic medical center, and only Level I trauma center. We hold magnet status for nursing excellence, and 80 of our affiliated doctors are ranked as America?s Top Doctors. But we don?t just take good care of our patients; our employee benefits are unparalleled, including medical benefits active on day one of employment, and a generous retirement plan. If you are someone that strives for excellence like we do, then consider joining our team. Reporting to the Director of Biomedical Engineering, the Bio Med Tech will assist Senior Techs with safety inspections, troubleshooting, repairs, preventive maintenance inspections, installations, and evaluations of medical instrumentation. Assists with staff education and providing equipment in-services to clinical staff as needed, and acts as the resource for Electronic Technician Trainees as appropriate. Documents all work performed to meet the requirements of any regulatory and accreditation authorities. Qualifications: ? Must demonstrate customer service skills appropriate to the job ? Must possess the skill, knowledge, and ability essential to the successful performance of assigned duties ? Ability to maintain a work pace appropriate to the workload ? Ability to read, write and communicate effectively in English ? Must work overtime as required to meet hospital needs ? Must be able to rotate call back duties on nights and weekends for emergency repairs ? Understanding of NFPA 99, CAP, Title 22 and other regulatory agencies for Clinical Engineering ? Current State of California Driver's License ? Ability to establish and maintain effective working relationships across the organization Preferred Qualifications: ? Understanding of JCAHO requirements...

Quality Engineer II - CEE Lab

Responsibilities:The incumbent will be a dynamic highly technical hands-on inquisitive engineer who will learn quickly, work with integrity, actively improve Alcon?s products and processes, and drive a culture of excellence. The incumbent will be responsible for the following activities: - Performs innovative effective complaint and failure investigations on complex electromechanical products- Makes impactful data driven statistically valid determinations (hypothesis testing, DOE, capability analysis, measurement system analysis, control chart, etc)- Identifies and takes action corresponding to emergent trends and opportunities for improvement.- Evaluates and presents KPIs and CTQs to senior management - Performs validation of new equipment and processes- Ensures adherence to and compliance with established company quality policies, practices, SOP's and federal regulations- Develops staff and processes in the CEE area of the QA department - Teaches critical thinking and creative problem solving - Drives a culture of quality, patient advocacy, and continuous improvement- Provides technical expertise to product action team and other departments- Identifies and drives process improvements...

Product Development Engineer (IRC4659)

The Product Development Engineer is responsible for developing new medical device systems from feasibility to prototype, through market introductions and field support in accordance with FDA and ISO requirements. The Product Development Engineer will provide solutions to a variety of technical problems under general supervision from senior engineering staff. Primary responsibilities are to: Design medical implant and instrument systems, generate CAD models and engineering drawings using Pro-Engineer software Maintain existing products with design and drawing revisions following standard operating procedures Interface with vendors on technical issues while supervising designs throughout the manufacturing process Support Design Control related activities and creation of other documentation Generate and analyze test data and reports to determine if designs meet functional and performance specifications Effectively interact with interdepartmental personnel and teams, such as marketing, purchasing, and manufacturing to uphold project plans and achieve project objectives Assist in the creation of inspection criteria Assist with field sales support and training Attend and participate in all team meetings as scheduled Perform other duties as assigned...

Biomechanical Engineer

Biomechanical Engineer : We currently seek an experienced biomechanical engineer to support operations in the Las Vegas area. Essential Job Responsibilities include analysis of human injury resulting from vehicular accidents, mechanical failures, falls, and falling objects, as well as industrial, construction, marine, and recreational accidents; Responsibilities will include practicing vehicle accident reconstruction; Review material (e.g., photographs, witness statements, depositions, police reports, medical and chiropractic records) to provide logical conclusions; Identify and apply pertinent research literature and government regulations; Conduct field evaluations and provide oral and written reports of findings; Provide expert witness testimony via depositions or in a court of law, as needed; Travel required primarily within the Western Region and occasionally outside the western United States as required to support the Company; Develop client relationships by providing and maintaining the company?s high standard of customer service excellence and proactive client communications; Work with local and national marketing managers to establish and grow relationships.; Multitask to meet the scheduling commitments of multiple clients and assignments....

Senior R&D Engineer - Medical Device

This long standing American medical technology company manufactures and sells medical devices, instrument systems and reagents, and employs over 30,000 employees in 50 countries around the world. The Medical Surgical Systems division manufactures infusion therapy products, and has a need based on continued growth and expansion in the market. Senior R&D Engineers needed to support product engineering and materials selection for all product platforms throughout the company. This position plays an active role int he product development and support processes to ensure products meet quality standards, and represents R&D on project teams. This is a permanent role, and offers long term career mentorship and growth. Relocation assistance to the Salt Lake City, Utah area offered. This company offers competitive compensation, bonus, full benefits, tuition reimbursement, generous 410k match and very pleasant working environment. Full job description upon application....

Staff Engineer

Staff Quality Design Engineer The Staff Quality Design Engineer is responsible for creating and implementing the Risk Management File, demonstrating statistical expertise, and injecting the voice of quality to assure quality and compliance for New Product Development (NPD) teams. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer. Essential Duties and Responsibilities ? Represents Quality Assurance on the New Product Development (NPD) cross-functional team (CFT). Interfaces among multiple departments and teams such as R&D, Regulatory Affairs, Advanced Operations, and Marketing to ensure specific product development metrics are met. ? Plans and leads departmental initiatives ? Creates and implements the Risk Management File for an NPD team. ? Leads Risk Management activities for an NPD team, including identifying hazards and harms that may be associated with the medical device. ? Leads Design Reviews for NPD teams to ensure design and process robustness and compliance to Corporate and Divisional design control procedures. ? Leads the exercise of understanding the functional inputs and outputs of the medical device. ? Plans, designs, and /or implements difficult methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment. ? Analyzes reports and recommends corrective action. ? Plans and develops difficult process and product protocols and monitors progress. ? Broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485) and how to apply the principles, practices, and procedures. ? Provides and/or reviews advanced statistical techniques for test sample size determinations. ? Uses and/or reviews advanced statistical rationale to plan, analyze, and interpret engineering test data collected during new medical device testing. ? Plans, leads, monitors, and/or controls progress of difficult projects to ensure sound application of engineering principles are used, and design intent is being achieved. ? Plans, selects, analyzes, designs, and/or improves difficult manufacturing procedures and engineering systems for medical devices. ? Plans and verifies that new difficult engineering devices are technically sound and in compliance with FDA and other regulatory bodies. ? Plans, performs, and reviews difficult engineering risk analyses to manage technical difficulties encountered with new medical devices. ? Provides leadership in the product development process by identifying effective test methods. ? Provides leadership and influence among multiple departments and teams such as R&D, Regulatory Affairs, Operations, and Marketing to ensure specific product development metrics are met....

Quality/Process Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: This is a visible position and is a great opportunity to make your mark. This organization is positioned for huge growth and this is a ground floor opportunity to make a tremendous impact in the company?s future. Essential job responsibilities include, but are not limited to: Provides quality and process engineering expertise to the organization while ensuring conformance to the quality management system (QMS), FDA and international regulations, and applicable standards. Assists cross-functional teams with the development of new products and the maintenance of existing product lines. Establishes and implements process improvement projects to drive customer satisfaction, maintain an effective QMS, and improve business productivity. Drives validation projects and documentation, develops and revises QMS documents, reviews validation and production reports/records. Implements a global manufacturing footprint as warranted by evolving customer demands worldwide....

Software Engineer III

TEKsystems is seeking a Sr. Software Engineer (level 3) to join their development team in Norcross. As an FTE they will be supporting numerous projects and many different products. Immucor develops software for the control of and the analysis of transfusion and transplantation diagnostics equipment; blood test equipment. All projects and products fit within this context. All developers are involved with all stages of the SDLC and should have previous experience conducting requirements definitions, software design, software development, test development and test execution. Majority of tasks are completed by the individual they are assigned to with little to no guidance. They will assist with peer reviews and conducts reviews on the work of more mid to junior developers. They will be looked on to own small features and/or take the lead of a group of engineers on a project. They are recognized on the team as someone who has expertise in a particular area. The Director expects Sr. Software Engineers to be able to provide advise or guidance to the team in making choices and is expected to identify issues and pull his director in when needed to discuss options on how to fix the issues. All products and projects vary in terms of where they currently are in the SDLC. They new development that will be done will be adding new features to existing products. They are a waterfall shop and the expectation is that a lot of time is spent on the front end gathering requirements and completing the design (they don't turn prototypes around quickly). The director is seeking developers who can develop front end, middle and backend. The majority of the new UI is being done in WPF. The majority of the development they do is Winforms but they do web as well. All the new development they do is done with C# .NET 4.0. They used to have a lot of C++ but have moved away however they do still maintain and fix bugs in the C++ code that is still in use. They are currently using SQL Server 2008 and above. Candidates should be able to write store procedures and triggers from scratch. They have 15-20 developers on the team and they Norcross, NJ, Wisconsin and Italy. They will be working with other developers, QA, systems engineer to gather requirements and verification engineers for testing in addition to them. They use Microsoft Test Manager (MTM) and Visual Studio to help test the application they build. MTM stores their test plans and results on Team Foundation Server (TFS). Typical day?everyone should have a rough idea of what they will be doing that day because their tasks will show up in their TFS account. They run morning stand up meetings every day and look at the burn downs so people have a good idea of where they are and where the project is expected to be. The biggest difference between a level 2 and 3 is the level 3 is more of a resource to others. Immucor HR Job Description: Are you a hardworking IT professional who's ready to get more out of your career? Immucor is a company in the biomedical technology field with a history of innovating to improve transfusion medicine and transplantation diagnostics. We have two business units: Transfusion Diagnostics, which includes our traditional serology products; and Transplant and Molecular Diagnostics, which includes the BioArray Solutions and LIFECODES products.We are on the lookout for qualified candidates to fill the role of Software Engineer. The Software Engineer will play a vital role, utilizing innovative systems and information technology "best practices" to further our goals and improve our capabilities across the organization. Job Responsibilities The primary role of the Software Engineer / Application Developer will be to develop software in order to support the creation of the company's applications. This role requires a strong set of skills, experience, and abilities from an individual who likes to think creatively and work independently. This position will work to gain recognition from clients and teammates alike as an expert in our products and services. Duties will entail: ? Creating and/or maintaining product requirements and design documents ? Developing, modifying, and fixing software ? Executing tests and debugging issues ? Doing traceability and requirements analyses ? Identifying issues and presenting solutions to team/leadership ? Providing technical leadership on specific areas ? Working with other departments to solve product-level issues ? Acting as a resource and mentor for junior engineers Job Requirements Qualified candidates applying for the Software Engineer position must have highly developed critical thinking and exceptional communication skills. This Application Developer role requires superior abilities in time management, workflow organization, and assignment prioritization. Multi-tasking is a "must" for success in this role! Desired qualifications of the Software Engineer: ? Strong C++ or C# skills; windows development (including Visual Studio) ? Strong exposure to software development life cycles (experience with TFS is preferred) ? Demonstrated experience in leading small teams (conducting technical reviews and coaching junior software engineers is preferred) ? Education & Experience - Master's degree and/or 4-10 years of related experience and/or training (or equivalent combination of experience); PhD is preferred but not required ? Language & Comprehension Skills - ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents; ability to effectively present information to top management ? Mathematical & Reasoning Skills - ability to deal with formulas, scientific equations, and a variety of abstract or concrete variables; ability to define problems, collect data, establish facts, and draw valid conclusions About TEKsystems: Join TEKsystems®, a leading IT staffing, IT talent management and IT services firm, and get your career on the fast track. We have more than 100 offices worldwide, and we partner with over 6,000 clients and place over 80,000 consultants per year. At TEKsystems, we seek to understand our consultants? skills, goals and interests, allowing us to present targeted job opportunities on a contract, contract-to-hire or direct placement basis. TEKsystems' leadership in the market stems from our sincere and personal commitment to driving the success of our customers, consultants and each other....

Principal Quality Engineer - Lenexa, KS

The Journey Begins with you. There's quite a distance between wondering and knowing. And for patients waiting for answers to important health questions, it's a road they want to travel as quickly as possible. At Quest Diagnostics Incorporated, we understand urgency. But more than speed, we focus our energies on accuracy. Currently, we seek a Principal Quality Engineer in Lenexa, KS. Work Schedule: Mon - Fri 8:00am - 5:00pm Responsibilities SUMMARY Provide technical analysis of processes that are involved in the development of products and the manufacturing of products in order to ensure that products developed and manufactured are consistent and meet specifications. Help and support such activities while ensuring that applicable standards and procedures are followed. Mentor and train manufacturing personnel. Participate in Project teams and represent Quality/Regulatory groups and ensure that Design Control requirements are met. Support Corrective and Preventive actions and ensure that Root Cause Investigations are performed using appropriate Quality Tools. Support manufacturing processes and ensure that validation activities are well- documented and performed. ESSENTIAL DUTIES & RESPONSIBILITIES Ensure that appropriate procedures are established to support Design Development and the Manufacturing processes. Review of design and development processes and ensuring that appropriate documentations are established during this process and in accordance with the Design Control procedures. Review manufacturing and validation activities to ensure that they are well established and compliant with the regulations. Establish purchasing controls and work very closely with suppliers of critical components and sub systems. Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis. Provide leadership in the application of Quality Tools such as Risk Management, Root Cause Investigations, Designs of Experiments, Capability Studies, in the establishment and investigation of process and products failures and implement lasting solutions of such failures. Develop process flow diagrams and perform gap analyses on current controls versus required controls. Establish methods to analyze and investigate the root cause of external and internal non-conforming products. Assist in corrective and preventive actions and verifications of effectiveness checks. Analyze data from customer complaints, internal audits, and internal and external suppliers non-conformance and implement appropriate solutions. Develop inspection procedures and apply statistical technics and appropriate sample plans. Gather, analyze, and report data reflecting status of product and process and provide recommendations to improve such activities. Participate in improvement and lean projects. Participate in Audits (Internal and External), and Regulatory authority inspections and ensure that risk to company is minimized as much as possible. Perform other duties as assigned. SUPERVISORY RESPONSIBILITIES None. EDUCATION and/or EXPERIENCE Bachelors Degree preferred in a life sciences discipline such as: Biochemistry, Chemistry, Microbiology, Biotechnology, Bio-Engineering, Molecular Biology, Animal Sciences, and Toxicology also Manufacturing Engineering, Quality Engineering and Quality Assurance. Five - 7 years related experience in IVD, medical device, pharmaceutical, or other related industry. Must have a thorough understanding of statistical analysis, statistical process control, Investigation and Root Cause Analysis, Corrective and Preventive Action Process, and their application to development and manufacturing processes as a problem identification and resolution tool. Proficient in Quality Analysis Tools (Taguchi, Fishbone) & DOE. FDA Product and Process Validation Techniques. Solid experience in Consumable/Reagents as applicable in IVD Industries. LANGUAGE SKILLS Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. MATHEMATICAL SKILLS Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis. REASONING ABILITY Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. CERTIFICATES, LICENSES, REGISTRATIONS ASQ Certified Quality Engineer Certified Quality or Biomedical Auditor How To Apply Please Log In or Register to Upload a Resume and complete the online Application. Because of the large number of applicants to job openings, Quest Diagnostics will only contact candidates to be interviewed Closing Statement Quest Diagnostics has many career opportunities for individuals whose talent, initiative and dedication will complement our belief that the patient comes first and that values do matter. We work to earn our customers trust every day by providing the highest quality diagnostic information services in a professional, accessible and informative way. Our workforce is diverse and talented and believes in our vision: 'Empowering Better Health with Diagnostic Insights.' [All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.] Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled. *CB* REQ# 3730151...

Consultant- Technology Specialist- Semi Conductor

Company Profile iRunway is a technology consulting and litigation support firm, with focus on intellectual property, specifically patents. We provide high-end technical consulting services to help leading corporations and law firms monetize patent portfolios and improve litigation outcomes. iRunway understands the challenges of managing and monetizing patent portfolios and are organized vertically to provide consulting services across four key areas: ? Patent litigation and licensing ? Patent portfolio analysis ? Financial valuation and damages assessment ? Technology research and due diligence Over the years, we have built technical expertise that runs broad and deep across several domains including software, internet/ e-commerce, telecommunication, networking, semiconductor and bio-medical devices. Clients include Fortune 500 technology corporations and leading national law firms. Our technology expertise delivered through our proven service has contributed to significant courtroom victories and favorable settlements for our clients, including ? ? $1.5 + Billion in Jury Verdict & Settlements. ? Supported over 40 law firms in 100+ patent litigations. ? 200+ Invalidity analysis and prior-art research projects. iRunway was established in 2006 by alumni from the Indian School of Business and Indian Institute of Technology. Job description This opening is for the position of Subject Matter Expert in Semiconductor domain. We are looking for a person with international experience and strong track record in Semiconductors - Fabrication processes, Semiconductor/Chip Packaging, IC/Circuit design, Circuit extraction, Lithography and Solid state electronics. Key responsibilities of the Technology Specialist: ? Drive the projects in the Semiconductor domain by mentoring the project teams. ? Identify the technology issues with the team and look for solutions to tackle the issues. ? Ensure all the deliverables are of high standards & technically accurate and consistent in meeting company standards. ? Develop a company-wide plan to enhance team?s expertise in the specific technology domain. ? Document, develop and refine scalable and repeatable process for all the Tasks worked upon. ? Work on internal initiatives according to requirements specified....

Mechanical Project Engineer

DJO Surgical has an immediate opening for a Mechanical Project Engineer position located in our Austin, TX manufacturing facility. We are located near 183 and Burnet Road in North Austin. We are the largest non-surgical orthopedic rehabilitation device company in the United States and among the largest globally. We also develop, manufacture and distribute a broad range of surgical reconstructive implant products through our DJO Surgical business unit. Summary: Work with a cross-functional product team consisting of upper level product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design and development of surgical instruments and implants including hip, knee, shoulder, and trauma devices. Function as a design engineer as well as project manager, managing entire product development process from concept through to production. Essential Duties and Responsibilities: Include the following. Other duties may be assigned. ? Work with marketing and customer to develop conceptual designs, typically in the form of SLA models or metal prototypes of the product and present those designs back to customer for evaluation. ? Maintain all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Verification Plans/Reports, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix. ? Develop project plans using appropriate planning software and periodically report on the progress of the project to upper management. ? Develop detail engineering drawings and release through ECO system. ? Work through internal prototype shop or contract through vendor on developing prototypes. ? Schedule and direct product team meetings, assuring timeliness of project execution. ? Maintain existing product lines, including attending NMR (Non-conforming Material Report) meetings and disposition product appropriately, attend weekly product complaint meetings and follow through with corrective/preventative actions, and write ECOs for general product improvement. ? Rely on instructions and prestablished guidelines to perform the functions of the job. ? Work under immediate and heavy supervision....

Sr. Quality Assurance Engineer (IRC6785)

Provide Plant Quality Compliance support for the following Quality tasks and duties: Introduction and launching of new or improved products and processes into the site. Participate in problem solving teams. Facilitate from a Quality and Quality Engineering and Plant perspective the launching of new or improved products/processes. Writing and coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product and material specifications, design and development documentation, SOP?s, development and task force projects. Facilitates the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration Regulations, ISO 13485:2003, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Investigate complaints generated from corporate complaints regarding materials produced in the manufacturing facility and/or assigned to the individual. Facilitate the launching of new or improved product/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective. Writing and coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product and material specifications, design and development documentation, SOP?s, development and task force projects. Aid other engineers in the development of statistically based sampling plans for in-process and final testing and inspections, and validations. Work with project teams to develop statistically sound tests for appropriate support of results. Develop, review and approve validations and completion reports for new and existing products, processes and equipment. Provide statistical analysis of the data to support the reports. Ensure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements. Support the Quality Management Review Process and other reporting requirements with appropriate data/information. Participate in FDA inspections, ISO certifications and surveillance audits and customer audits. Support corporate Regulatory Affairs by providing information for submissions. Identify and implement opportunities for continuous improvement. Interact and coordinate activities with other departments, external vendors and customers. As required, assist or lead in the prompt implementation of non-Conformance resolution, and Corrective and Preventative Actions(s). Aid in the implementation SPC control system with Manufacturing, Quality Control, and other Quality System. Perform other Quality Systems related duties as required....

Engineering-Sr. Engineer

Mechanical/ Biomedical/ Chemical Medical Device Engineer: 3 ? 5 yrs medical device experience working in Design Control governed environment. Knowledge of device Design History File structure, Risk Management documentation and Product Requirements management, and Test Method Validation. Experience using DOORS would be highly desirable. Ability to develop and execute verification and validation protocols translating product requirements into test / use cases, essential. Design and development of precision plastic devices and components, experience in use of biocompatible materials and packaging and sterilization techniques. Rapid prototyping skills, experimental design and protocol development and technical report writing. Proficient in single use and multi-use disposable medical devices, disposables / systems interface knowledge and requirements development, verification and applying statistics. General: Works as part of a team performing standard engineering work requiring application of standard engineering techniques, procedures and criteria. Work is closely supervised. 1. Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, theories, Corporate and division SOP's, policies and projects. 2. Document development work including writing specifications for manufacturing or scientific test results. 3. Ability to solve routine design and engineering tasks with some assistance. Able to solve problems with periodic monitoring. 4. Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects. Job Requirements Minimum qualifications: 1. Ability to discuss normally encountered technical or project management issues, both verbally and in written form. 2. Ability to work as a collaborative team member. 3. Ability to solve routine design, engineering problems with assistance B.S. and 3 - 5 year related experience (in-house, co-op or acquired outside). *cb...

CT Detector Physicist/Scientist

Summary Participate with other professionals in design, development of the next generation of CT detector, including photon counting and energy discriminating systems with a focus on detector characterization and subsystem integration. Responsibilities Detector Characterization ? Design and perform characterization on CT detector components ? Develop models to predict CT detector performance Detector System Integration ?Interface with other multidisciplinary groups including Physics, Electrical Engineering, and Mechanical Engineering to build and test prototype CT detector systems ? Develop and perform CT detector system calibration...

Clinical Engineer

Bachelors Degree Preferred Manages the inspection, testing, calibration repairs and preventative maintenance on clinical and non-clinical hospital equipment and systems. Researches and implements innovative and new technologies within the facility. BS strongly preferred, AS minimum in Electrical Engineering Technology, an Allied Science, or equivalent. Certification as Biomedical Equipment Technician (CBET) or eligibility for certification....

Research Engineer

MED Institute, Inc. is currently accepting applications for a Research Engineer to become a part of our growing Product Discovery team. The successful candidate will support and lead research and development of novel medical devices. The candidate will work within an interdisciplinary team of engineers and scientists evaluating novel design concepts for new medical products and will also be expected to independently formulate new concepts and produce prototypes. Familiarity with a variety of medical device materials would be advantageous. Responsibilities Collaborate with and lead interdisciplinary teams of scientists and engineers to discover and develop novel medical devices; Develop methods for prototype device fabrication; Take a ?hands on? approach to fabrication of concepts and prototypes; Research new technologies and integrate new capabilities into the product development team; and Lead and assist in the development of experiments, execution, analysis of results, interpretation and reporting of results; Identify problems and propose + develop approaches for solving them. Essential Qualifications MS, or PhD in Engineering (Mechanical, Biomedical, Materials, etc) or a related field; Experience with medical devices is strongly preferred; Experience working in and leading multidisciplinary teams is beneficial; Must be highly flexible, have a hands-on approach and be willing to take the initiative; and Ability to communicate well through written and verbal means is required....

Senior Product Development Engineer

Job Summary: Position will direct, coordinate, and exercisefunctional authority for planning, control, integration, and completion ofdevelopment engineering tasks within area of assigned responsibility byperforming the following duties personally or through cooperation with teammembers and supervisors from other departments. Essential Duties: Plans and implements engineering project tasks, activities and milestones to support projects and sustaining engineering within the product development organization. Develops and maintains schedules and budgets for the assigned engineering project tasks which are submitted for management review and approval. Provides reports on the status of project tasks and milestones to project managers. May train, develop, and evaluate Engineering Co-Op students, Interns, and Product Development Engineers. May also manage one or more co-ops. Aware of NPI process and Design Control requirements on an Individual basis. Stay compliant with healthcare compliance policies as related to communication and interaction with healthcare providers. Required to support or lead "Needs Assessment Documents" (NAD) as related to current compliance subcommittee SOPs. Exercises some decision-making authority, later verified by the Department Supervisor. Advises the Department Supervisor, or designee, of transactions and/or special concerns on a daily basis. Performs related duties as required....

Senior Product Development Engineer - Sports Medicine

Job Summary: Position will direct, coordinate, and exercisefunctional authority for planning, control, integration, and completion ofdevelopment engineering tasks within area of assigned responsibility byperforming the following duties personally or through cooperation with teammembers and supervisors from other departments. Essential Duties: Plans and implements engineering project tasks, activities and milestones to support projects and sustaining engineering within the product development organization. Develops and maintains schedules and budgets for the assigned engineering project tasks which are submitted for management review and approval. Provides reports on the status of project tasks and milestones to project managers. May train, develop, and evaluate Engineering Co-Op students, Interns, and Product Development Engineers. May also manage one or more co-ops. Aware of NPI process and Design Control requirements on an Individual basis. Stay compliant with healthcare compliance policies as related to communication and interaction with healthcare providers. Required to support or lead "Needs Assessment Documents" (NAD) as related to current compliance subcommittee SOPs. Exercises some decision-making authority, later verified by the Department Supervisor. Advises the Department Supervisor, or designee, of transactions and/or special concerns on a daily basis. Performs related duties as required. Job Specifications: Requires the ability to be aself-starter requiring minimal supervision to accomplish assigned tasks. Independently solves practical problems and deals with a variety of concretevariables in situations....

Sr. Development Engineer

. Adecco Engineering and Technical is currently recruiting for a Senior Product Development Engineer that will be located in Warsaw, Indiana. You must have experience with new product development within the medical device field. You will direct, coordinate, and exercise functional authority for planning, control, integration, and completion of development engineering tasks within area of assigned responsibility by performing the following duties personally or through cooperation with team members and supervisors from other departments. Job Duties: Plans and implements engineering project tasks, activities and milestones to support projects and sustaining engineering within the product development organization. Develops and maintains schedules and budgets for the assigned engineering project tasks which are submitted for management review and approval. Provides reports on the status of project tasks and milestones to project managers. May train, develop, and evaluate Engineering Co-Op students, Interns, and Product Development Engineers. May also manage one or more co-ops. Aware of NPI process and Design Control requirements on an Individual basis. Stay compliant with healthcare compliance policies as related to communication and interaction with healthcare providers. Required to support or lead "'Needs Assessment Documents"' (NAD) as related to current compliance subcommittee SOPs. Exercises some decision-making authority, later verified by the Department Supervisor. Advises the Department Supervisor, or designee, of transactions and/or special concerns on a daily basis. Knowledge and skills identified are typically acquired by completing a Bachelors degree in Mechanical Engineering or Biomedical Engineering from a four-year college or university; 8 years of medical device development experience or equivalent combination of education and experience. Medical Device industry experience preferred in either a manufacturing or product development engineering position, preferably both. Sincere interest in the medical device business with the drive to develop new products to keep pace with new technologies; required. If you are interested in this Sr. Product Development Engineer job opportunity in Warsaw, IN then please click APPLY NOW. For other opportunities available at Adecco Engineering and Technical go to www.adeccousa.com. If you have questions about the position please contact Faith Hoskins at 317-842-2870 or ....

Modeling and Simulation Engineer

Experienced Modeling and Simulation Engineer Education: Minimum 4-year degree in Mechanical, Biomedical, or Aerospace Engineering Requirements: US Citizen residing in the Cincinnati Area with great work experience in Modeling & Simulation - Are you a creative problem solver? - Do like being in a constant mode of discovery? - Are people amazed that you never give up? Kinetic Vision develops new technologies. Recognized as a Top Workplace in 2014 , we are a fun team of people who are driven. Quality and timeliness are paramount and we love to deliver the job completed correctly the first time. Our Modeling & Simulation group is defining the frontier of Digital Engineering. Constantly expanding the boundaries of efficiency, we are helping our partners replace physical prototypes with virtual testing to help better understand and develop new products. Always going beyond the one-off finite element analysis, we are tasked with creating tools for design screening, sensitivy studies and direct physical validation. Our expert team focuses on execution in conjunction with teaching our partners how to integrate simulation into their production workflow....

Senior Packaging Engineer

Johnson Service Group is seeking a Senior Packaging Engineer for a full time direct hire opportunity in Atlanta area. The position will support the development of a new fractionation facility that will bring additional capacity for testing, purification, and fill and finish for its biologic medications. Position will play a leadership role as the Engineering lead/representative for the finished product packaging area. Responsibilities include developing, evaluating and implementing cost-effective equipment, facility and utility engineering solutions for a greenfield manufacturing facility in a fast-paced cGMP, biotechnology environment. This includes all phases of the project covering detailed design, specifications, equipment and systems procurement, contractor and consultant supervision, creating and executing change control documentation, performing factory and site acceptance tests (FATs/SATs), installation, commissioning, debugging, optimization, supporting Validation and training maintenance and manufacturing personnel. Essential Duties and Responsibilities Support project planning and execution by working in a cross-functional team as the Engineering lead/representative for the finished product packaging area. Work independently with minimal supervision to execute respective area of responsibility based on supporting data, technical knowledge, engineering principles and current industry practices. Assist in the development of operational and user requirements to ensure requirements are integrated into the design requirements to meet project and business needs. Support definition of project scopes, cost estimates, and justifications for major capital budget. Drive projects to completion to meet quality, timeline and budget objectives. Able to participate and make suggestions for capital planning, spending, and tracking. Create or update written Standard Operating Procedures (SOPs) related to project assignments. Create, review or update technical specifications, URS?s and automation design documents for process equipment and related systems....

Sr Principal Packaging Engineer - Sterile Finished Products

O ne of my clients, a large international biopharmaceutical company, is building a brand new state of the art, greenfield site facility in a very attractive, low cost of living area in the Southeast. They are looking for a senior level Principal Packaging Engineer with SME level expertise in automated packaging and labeling equipment design, vial labeling, serialization? The Principal Packaging Engineer will play a lead role in their sterile finished products engineering initiatives and be recognized as a "go to" packaging technical expert....

Technical Director

Technical Director Technical Engineering Manager or Senior Technical Engineer for Turbocoating Corp. based in Hickory NC. Role: We are seeking a Technical Director in our Hickory, NC manufacturing facility. The successful candidate will possess significant experience Thermal Spray coatings industry with increasing responsibilities in manufacturing operations. He / She will be the technical lead for product and materials with key customers and will lead the engineering aspects of the company. The candidate will be responsible for bringing new product and processes to market on time and within budget. As a senior leader in the operation he / she will lead techniques and processes, teach and mentor Engineering best practices (Lean, Six Sigma, DFM, DFA, DOE, FMEA, VA / VE, etc.) and lead technical discussions with various customers. Occasional overseas and domestic travel will be required to support the rapid growth of Turbocoating Corp. Company: The season professional will be employed by Turbocoating Corp., one of the main companies of Unitedcoatings Group. Unitedcoatings Group is a world leader in the Thermal Spray industry and is active, through its different operating business units, in both European and American continents, with 3 main Divisions: Industrial Gas Turbine and Aviation, Biomedical and Equipment. Turbocoating Corp. is settled in Hickory (North Carolina) and is a leader in the ready-to-engine airfoil applications market, namely thermal spray coating / post coating applications for Gas Turbine components. The company currently employs about 70 people, reports sales revenue nearing $20 million, and has a very fast growth path that will lead to more than double the organization and the business in a short period of time. Key Responsibilities: The Technical Director will report to the General Manager. In this role, the candidate will be responsible ensuring all metrics for Safety, Quality, Delivery, and Cost for the organization are met and trending in the right direction. Proper production preparation, quality, time accuracy, through the implementation of continuous improvement are key. The responsibilities of the Technical Director include but are not limited to the following: Act as lead technical reference for customer and internal organization in the case of materials, coatings, and assembly application Develop and continually improve a documented process for Product Realization Review, analyze, and offer Value Analysis / Value Engineering options to customer specifications and requirements. Manage qualification kick-off and ongoing stage gate meetings. Constant follow up and put decisions into actions Develop production costs quotation and related feasibility study as member of a cross-functional team Determine and approve the production flow of a new component, fulfillment of its qualification steps and providing the customer products responding to the required quality specifications within the due date and within budget Support and survey job orders with full documentation, issue and update the component?s final leaflet and file all documents in their proper order Check component standards in order to promote actions for cost savings and process standard improvement. Conduct time studies and implement improvement methods to reduce cost Lead Root Cause Corrective Action activities to permanently eliminate defects Adhere to the Company's Quality and Safety Management System and in accordance with its procedures and requirements Utilize Lean and Six Sigma methods to improve Key Performance Indicators for Safety, Quality, Delivery, and Cost Participate in Kaizen events, promote positive employee environment, and community involvement...

Level I Validation Engineer/Specialist

Performance Validation, LLC has provided Commissioning, Qualification and Validation services to the life science industries for over 20 years. PV is an Indiana LLC company with local offices in Indiana, Illinois and Michigan providing support throughout the US and overseas. Performance Validation is seeking a full-time Level I Validation Engineer/Specialist based in Augusta, Georgia. The Level I Validation Engineer/Specialist reports directly to the Division Director or Manager and will be assigned to one or more project teams headed by a Project Leader. Expectations: This individual is expected to develop a sound understanding of how to properly implement technical, quality and scientific principals necessary to meet industry and customer requirements. This individual is expected to work in a team environment to meet defined objectives based on an established timelines. Responsibilities: Perform validation and commissioning activities including: Receipt Verification, Installation Qualification; Operational Qualification; Performance Qualification; Requalification; Laboratory Qualification; Methods Validation; Process Validation; Computer system Validation; Aseptic Validation; Cleaning Validation. Support cGMP programs including: Preventive Maintenance and Calibration. Writing Standard Operation Procedures. Learn and apply principles of operation of new equipment/ instrumentation/ methodology/ processes and their associated controls; Identify critical parameters affecting quality or safety; and relate those critical equipment parameters to the overall process, including associated specifications, drawings, and technical documentation and performing walk downs, which may include climbing stairs, climbing on equipment, moderate lifting and walking. Assist in the development of practical methods for inspecting or testing compliance of critical parameters and developing the appropriate procedural steps for performing those tests and inspections. Assist in the development of concise acceptance criteria for an operational test or inspection. Reviewing data to determine compliance with acceptance criteria. Apply good documentation practices in execution of protocols, procedures, and other cGMP documents. Assist in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements. Assist with corrective actions....

Quality Assurance Engineer

Responsibilities will include continuous improvement and maintenance of ISO9001:2008/AS9100C quality management system pertaining to customer, external, internal, and supplier activities. Position adds value by working with Manufacturing, Sales, Engineering, Planning and other functions to solve problems, prevent nonconformances, and improve processes in a quality management system supporting production of material for the aerospace, biomedical and nuclear industries. #LI-JH1...

Project Manager - Medical Device - Pharma

Our client is adivision of a global Medical Device manufacturer, seeking a ProjectManager who will be responsible for delivery and launch of MedicalDevices to the market. Projects will include enhancements to existingproducts as well as new product launches. The Project Manager will leadthese efforts by leading cross-functional teams and ensuring that eachteam member is completing their assigned tasks in a timely manner toachieve project goals. Responsibilities: Works with cross-functional teams with representatives from R&D, Quality, Marketing, Regulatory Affairs, Packaging, Supply Chain, Operations, Finance and Manufacturing to deliver new products and product enhancements Organizes team activities, including providing detailed minutes of all project meetings, monitoring progress against the project schedule, ensuring that team activities are supported Works closely with Marketing, Clinical Development and Manufacturing functions to ensure understanding of product application and serves as Voice of the Customer when interfacing with project teams and external partners Ensures that projects are managed in accordance with company policy Plans and leads projects, working with engineers and non-technical team members Responsible for conducting project meetings, design reviews, and publishing and following up on action items, and is the driving force to keep the project on schedule Ensures that progress is reported and that all stakeholders are up-to-date on project status Responsible for project budget...

R&D ENGINEER

Under minimal direction, this position is responsible for the design, development and maintenance of Interventional Access products through adherence to established design control processes, good engineering and documentation practices. Organize, lead and manage multiple projects to ensure completion in a timely manner. Create design ideas for new products as well as creative solutions to existing products when problems arise or modifications are requested. Perform other related duties as required. PRINCIPAL RESPONSIBILITIES: (Description of major duties and responsibilities of the role.) 1.Engineering lead for all aspects of new product development or sustaining engineering including the design, prototyping, testing (verification and validation) risk management and documentation. Lead the redesign of existing components and qualifications of new components to improve quality, utilize automated production techniques, optimize process capabilities and produce better products in a more cost-effective manner. 2.Conduct research and development for new design and modifications of medical devices, components, models or mechanisms. Understand and fully implement design modifications to medical devices and components. 3.Design new products and product improvements. Plan and implement R&D prototyping activities. 4. Source, develop and qualify device components and materials with new and existing suppliers. Obtain quotations, purchase components and debug problems with current production parts. 5. Conduct hands-on product testing and documents test results as required. 6. Generate and recommend detailed design features and/or design changes to improve manufacturability. 7. Prepare engineering cost estimates and project budgets. 8.Document all new ideas for products and/or processes using Teleflex?s Intellectual Property Engineering Notebook. 9. Generate Teleflex documents as required to fully define products and processes, including drawings, procedures, flow charts, BOMs, process routings and other DMR elements. Prepare or coordinate formal documentation of the Product Designs, Risk Analyses, Product Specifications, Market Specifications, Trace Matrices, etc. according to established Product Development Procedures. Initiates formal reviews and approvals per said procedures. 10. Interface with clinicians, marketing, and process development to understand customer preferences/requirements and establish design criteria for new products and product improvements/changes. 11. Support regulatory submissions and clinical trials as required. 12. Serve as the project leader for assigned projects and responsible to follow up on all aspects of projects, including reviews with support groups and outside resources where applicable. Utilizes project plans, MS Project timelines and schedules to track and communicate developments from prototype design through testing and into production. Formulate decisions to facilitate project advancement independent of supervisor. 13. Lead project team members to meet project objectives, milestones, and target dates. Assesses project issues and develops resolutions to meet product specifications. 14. Develop and coordinate the running of verification and validation test protocols for new/modified devices or components. Includes validations for design, manufacturing process, assembly, packaging, and sterilization where applicable. 15. Coordinate the product design and development process with appropriate support departments such as engineering, regulatory, documentation, drafting, technicians, tooling and manufacturing. 16. Lead, conduct and/or participate in design and technical phase review meetings. 17. Support investigation of product complaints to determine cause and implement corrective action. 18. Represent the engineering department at hospitals, scientific sessions, and seminars to meet with medical personnel and discuss product line requirements and trends. 19. Investigates and resolves product-related technical problems in engineering and manufacturing areas. 20. Manage supplier initiated changes as required to sustain supply chain following applicable standard operation procedures. 21. Interface with purchasing and marketing to develop supplier agreements for components and/or new products. 22. Train, mentor and assist other engineering personnel. 23. Ensure that projects are developed and documented in compliance with Teleflex?s Quality System. 24. Stay current with cutting-edge medical device industry and technology trends to ensure innovative product design. 25. Enhance self growth and development through participation in education programs, current literature, training meetings and workshops. 26. Demonstrate professional responsibilities by cooperating with other personnel to achieve department objectives, maintain good employee relations, interdepartmental objectives and departmental goals/objectives. 27. Adhere and ensure compliance to Teleflex?s Code of Ethics, all Company policies, rules, procedures and housekeeping standards. Incorporates Teleflex?s values/goals into own work priorities....

Electro-Mechanical Engineer

ATI Industrial Automation is the leading engineering-based world developer of robotic accessories and robot arm tooling. Recognized throughout the world for quality and reliability, ATI products are improving productivity in an array of industries, including Robotics, Aerospace, Biomedical, Automotive, Electronics, Applied Research, Academics, Nuclear and Governmental. In our continued quest for excellence in our products and service, we are seeking an experienced, hardworking, team-oriented Electro-Mechanical Design Engineer. Major Duties and Responsibilities General Engineering/Project Management Responsibilities Use engineering principles to design and modify robotic end effectors and tools. You will work with other engineers, designers and Manufacturing personnel to complete design projects. You will communicate with managers and Manufacturing and Sales staff concerning your design project. Investigate and resolve technical problems involving product performance, production equipment or facility systems affecting production. Perform a variety of engineering tasks in the planning and design of electro-mechanical products, manufacturing and assembly tooling, electrical enclosures and cable assemblies. Determine and establish specifications through engineering calculations and layouts. Use appropriate engineering tools such as, CAD, FMEA, DFA, in the successful completion of design projects. As a Project Leader you will coordinate all phases of development including creation, prototypes, testing and analysis. Establish and monitor adherence to time lines and schedules. Complete all project documentation required, direct the efforts of assigned support personnel as required to ensure on time project completion, be responsible for tracking the cost of components with minimizing cost as one design criteria and work closely with all areas of the company to successfully complete the projects. Work with component suppliers, manufacturers, outside labs and other service providers as needed to assure the most cost effective, robust designs are implemented. Continue to learn new skills and techniques through in-house training, outside training/coursework, seminars, trade shows and appropriate use of the internet and participate in the training of other members of the engineering team in these skills. Communicate with customers and the Sales staff to determine all the technical specifications for a project. Continue customer interface as required during the design, production, implementation and trouble shooting of the product, including plant trips as required. Provide support and assistance to coworkers as appropriate to enhance the performance and success of the engineering department and the company as a whole. Product design and development done by the study of the robotic and automation market for new ideas (e.g. patents, trade magazines, trade shows, plant visits) and personal creativity. Electrical Engineering Tasks Provide electrical engineering support and development for existing and future electrical products. The primary focus will be on supporting the development of new products in the Electrical Module group. This shall include: Developing improvements in current electronics. This will include the development of new PCBs to facilitate module assembly, reduce overall cost and parts count, and/or to provide a significant functional advantage. Check the customer and assembly drawings of electrical modules created by the Electrical Module group. Support and troubleshoot current electronic designs. Develop engineering standards relating to the electrical characteristics of ATI products. Electrical schematic creation in Orcad. Mechanical Engineering Tasks Create models and drawings in SolidWorks or equivalent solid modeling CAD package. Prepare detail and assembly drawings for complex products and equipment. Design and develop new models, mechanisms, or adaptations for a particular product or application. Develop correct proportions, giving consideration to stress, speed, weight, proper function and manufacturability. Perform tolerance analysis to ensure proper fit/function of completed assemblies and to minimize parts cost....

Manager, Visual Inspection Engineer

Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Every day, the company invests more than one million Euros in research and development. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients? needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Manager, Visual Inspection Engineer SME in Visual Inspection for the Swiftwater Site. Provides technical support and/or leadership to all Visual Inspection related subjects for site: Adjustment/tuning automated inspection machines Qualification of automated inspection machine recipes Support the identification of critical process parameters and acceptance criteria for development and validation Training on the application of automated inspection machine configurations to optimize detection of defects in final containers, especially containers having particulates. Technical trouble-shooting and deviation investigation related to Visual Inspection Automated inspection machine equipment specifications, new vendor/equipment selection, and startup of new equipment SME for health authority inspections Stays up to date on latest technical and regulatory trends in the biomedical imaging science, optical engineering and visual inspection arena...

Field Service Engineer (215260-017)

Responsible for maintaining the reputation of AngioDynamics hardware as reliable and high-functioning medical equipment by providing the technical support, complex troubleshooting, and general maintenance of customer and company-owned hardware either in the home office or on-location with a focus on customer relationship building through prompt and efficient service. Position Responsibility: Perform hands-on assessment of hardware received for repair; implement diagnostic process and perform applicable repairs. Perform hardware installations and repairs at customer sites as needed with traveling flexibility. Ensure customer hardware is upgraded as needed; perform upgrades to hardware/software at customer locations. Collaborate with R&D in the development of technical documentation such as test methods, training updates, and service reference material. Submit ECOs as required for the amendment of test methods, training materials, service reference material, and other applicable SOPs. Make strategic recommendations to supervisor related to hardware service initiatives based upon field experiences and observations. Develop strong working relationships with biomedical departments, physicians, other hospital staff, office personnel, and outside sales personnel. Act as first point of contact for technical queries, providing troubleshooting and support by phone in case of equipment failure including out of hours ?on call" support. Follow all relevant SOPs and Service database procedures, utilizing the systems to their fullest potential and proactively suggesting and developing improvements to processes. Maintain a clean and safe working environment ensuring efficient and effective use of space in compliance with all regulatory standards. Actively participate in project teams, representing the hardware service department in a professional and cooperative interdepartmental atmosphere. The above is not intended to be an inclusive list of responsibilities. Other activities may be assigned as required by management....

TECHNICIAN, ELECTRICAL & COMPUTER ENGINEERING, AFT 21

We are seeking a qualified, competent and service oriented technician for Rowan University?s Electrical and Computer Engineering (ECE) department, to meet the technical support needs of our growing faculty and student population, as well as our expanding laboratory facilities. The ECE technician will work in a multidisciplinary environment that includes Civil & Environmental, Chemical, Biomedical, and Mechanical Engineering, however, the primary assignment is to the Electrical and Computer Engineering department. The candidate must be capable of multi-tasking on many difficult problems in a fast-paced environment. The technician must be available to work day and evening hours (until 7:30 PM or later). The duties of the technician include working closely with students, faculty, and staff to: ? Assist in development and maintenance of laboratory facilities to support innovative engineering education and research programs of the highest caliber; ? Assist students and faculty with the design, prototyping, fabrication, set-up, and operation of laboratory demonstrations and experiments for classes, engineering clinics, and research projects; ? Advise students on their designs and prototyping projects; ? Maintain safety and regulatory standards; ? Provide individual and group training to students, staff, and faculty on lab safety procedures, and the proper and safe use of instrumentation; ? Monitor students in laboratories to insure safety, and assist with lab experiments, teaching, or any other duties necessary to aid in the educational process; ? Help specify and procure laboratory equipment and supplies, maintain department inventory, ensure that necessary materials and supplies for labs are in stock; ? Assist in the maintenance of departmental laboratory and field equipment and facilities; ? Install and maintain engineering software and conduct engineering software training for students; ? Interview, hire, and oversee undergraduate student workers to help with the above duties; ? Assist students in the practical applications of electronics, computer architecture, circuit theory and other areas of electrical / computer engineering. Qualifications ? Bachelor of Science in Electrical and/or Computer Engineering or a similar / equivalent degree; and/or relevant work experience ? Expertise in lab safety procedures ? Expertise in using, maintaining and troubleshooting commonly used ECE test / measurement instrumentation and equipment ? Experience with calibrating ECE laboratory instrumentation ? Experience with embedded design using a variety of processors such as PIC, MSP430, ARM, etc. ? Experience with rapid prototyping equipment, such as 3D printer, laser cutter, water jet, drill press, milling machine, lathe, table saw, band saw, etc. ? Experience in programming, such as assembly, C, C++, Java, HTML, etc. ? Experience in the use of electrical / computer engineering software for design and analysis such as LabVIEW, Cura, Visual Studio, MPLAB, Code Composer Studio, Altium, AutoCAD, LTSpice, Matlab, etc. ? Experience in PCB design and mechanical packaging design ? Work experience in an industrial or commercial environment as well as academic teaching experience ? Appropriate legal status to be employed in the United States Start Date: September 2014...

Principal Packaging Engineer

The selected candidate will be responsible for the package development activities for sterile dosage forms. Conducts tests on alternate packaging materials and final package for stability studies and coordinates the packaging of stability supplies for new products. Provides technical expertise to the manufacturing teams assisting with the resolution of problems associated with packaging/component equipment conflicts. Directs packaging technology efforts on several major projects concurrently. Sources, tests, qualifies and documents new packaging components across a wide variety of types of materials and formats. Coordinates both internal and external resources to complete projects. Recommends improvements to packaging component design. Directs packaging material suppliers to new areas of innovation. Provides sterile packaging technical assistance for quality and regulatory activities including: preparation of technical documents for regulatory filings. Responsible for driving the development of new technology to resolve packaging related issues. Responsible for successful project execution according to established objectives, timelines and costs. This candidate must have the ability to manage package development activities from concept through launch. Ability to translate pharmaceutical and packaging industry trends to business opportunities....

Senior Engineer (Research and Development)

Manage and implement technical engineering activities associated with product development to complete product design, performance evaluation, packaging development, process scale up and transfer to manufacturing, and launch. Create and implement technical project activity plans. Manage Design Control requirements and provide project management support for product team activities. Responsibilities: Provide technical leadership to plan and implement technical product development activities leading to the production and launch of new products and product line extensions. Work closely with research and surgical leaders in the medical fields of interest to establish technical user and engineering requirements and the studies necessary to verify that those requirements have been met. Evaluate new technologies to identify and coordinate implementation of new equipment, materials, processes and external suppliers that can affect product development outcomes against required goals. Prepare study protocols and written outcomes reports including conclusions and recommendations based on statistical analysis. Manage the technical activities associated with Design Control. Supervise internal and external technical resources to complete required tasks including the key categories of specification development, safety and efficacy testing in vitro and in vivo, performance and stability studies, first level process development including equipment design and transition to manufacturing, validations, packaging development, product launch, technical support for regulatory submissions, and technical support to marketing and sales. Establish formal technical plan for achieving product development objectives including goals, resources, tasks, timelines, and risk assessment necessary to transition a project from research through development, scale-up and launch. Provide project management support for major projects both within MTF and with MTF?s partners. Maintain records to document novel design and process development activities for Intellectual Property development. Identify and implement cost improvement opportunities for current and new processes. Prepare and manage program or department budget. Provide routine project status and summary reports....

Post Market Risk Management Engineer-US - NY - Rochester - CNP

Ortho-Clinical Diagnostics, Inc. (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company has approximately 3,800 employees around the world serving the global clinical laboratory and transfusion medicine community, and is committed to providing customers with products, services and process solutions to make labs more efficient in delivering the quality test results doctors and patients need. OCD was recently acquired by global alternative asset manager The Carlyle Group as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide. Ortho Clinical Diagnostics, a global company, is recruiting for a Post Market Risk Management Engineer to be located in Rochester, New York. This is a highly independent role performing analysis of customer complaint data and identifying product quality trends; providing data & insight for investigations and resolution of product quality issues across all WW LoBs for OCD. The role requires an oversight of complaint vigilance, regulatory compliance and escalation of post market quality issues. A key feature of this senior role is to ensure that active programs of work are in place to prevent future recalls/field actions; and for these programs to be identified and driven through analysis of actual and potential risks. The incumbent is expected to operate at a senior level and to interface directly with WW Health Authorities. This role also has the responsibility for developing and overseeing processes for driving post-market information assessment and potential impact to marketed products (e.g. labeling changes, identification and assessment of new risks) and for ensuring that product risk management files are updated (by appropriate owners) on a periodic basis. The latter aspect of this role is viewed as complimentary to risk pre-market risk management. As a subject matter expert for the recalls / FSCAs / escalation processes and post market risk management the role holder will provide support for audit/inspection support for internal/external/regulatory inspections. Overseeing the Product Quality Review (Escalation) process including issue consultation and classification while liaising with senior company and corporate management, Legal and WW Health Authorities*. Overseeing Health Hazard Evaluation development, recording inputs and outputs of process to help assure efficient review of issues as well as to assure an audit ready state of the records (including content and timeliness of the records)*. Manage and maintain a worldwide process for product risk management files for all launched products (across all LoB's) and to ensure that they are reviewed on a periodic basis and updated as appropriate in light of newly identified risks or changes in use or changes in risk: benefit ratio*. Leading and demonstrating effectiveness of Field Action Review Board for all reportable field actions and near misses. Responsibilities include: tracking issues, assuring timely progress of Root Cause Investigations and CAPA development, participate on the Life Cycle Management Teams, monitor Health Authority web sites for current and emerging trends and data comparisons. Assist with the management and maintenance of worldwide recall/FSCA, etc. and associated records (for all company sites and lines of businesses) that comply with requirements of FDAs corrections and removals (recall) regulations and Corporate Policies to protect the company from adverse regulatory action. Managing or writing FDA notification reports (initial and all follow-ups) within regulated timeframes to assure compliance with federal regulations. Being primary liaison with FDA, WW Health Authorities, OCD and Corporate Management to help assure effective and timely response to any inquiries made. Supporting OCD affiliates worldwide when they report recalls to their Regulatory Authorities*. Managing foreign affiliate and US follow-up communication processes. Assisting in the development of recall implementation plans to assure compliance with worldwide regulations*. Qualifications Degree qualified in Quality, Regulatory or Scientific discipline (e.g. Biomedical, biochemistry, analytical chemistry 5 years experience in a quality/regulatory/healthcare environment Must have knowledge of NC, RCI, CAPA processes Must be able to demonstrate experience in data analysis and presentation Must have front room experience in HA audit / regulatory inspections Basic statistical and data analysis skills Previous WW HA reporting / interaction is desirable...

Electronics Engineering Technician

Electronics Engineering Technician - OVERVIEW OF ASSIGNMENT The Technician will perform electronic device upgrades under the direction of Field Service Engineers at various customer hospital facilities. JOB DUTIES The Electronics Technician will work under direction of an on-site Field Service Engineer, and will receive training on how to perform the assigned tasks including procedures for basic pump device self-test, Performance Verification Testing, and use of basic related test equipment such as an electrical safety meter. Under normal circumstances throughout the field correction project, intentions are to work on-site at the various hospital locations only on Monday through Friday 8a-5p. In some specific situations, schedules will vary per hospital restrictions and may encounter a need for an hour or two of overtime during the scheduled period to help close out completion by the projected date if that will avoid extending the schedule, but that will be on a case-by-case basis. Technicians must be capable of: ousing standard hand tools to open electronic devices removing and replacing circuit boards operforming device self-tests in compliance with provided procedures oproviding clear hand-written records of device upgrade information on provided document. Document results as instructed in the procedure and as specifically directed by the FSE. Communicate or redirect any question or inquiry from a customer s representative to the a FSE. SKILLS REQUIREMENTS -Technician must be competent and capable of fulfilling the job duties with excellence while working on-site in a field team environment. -Position requires two or more years of recent electronics experience as a field level, or manufacturing technician. -Previous experience with exposure to upgrading, fixing or installing hospital based Biomedical instrumentation preferred but not required -Must be able to lift and move devices weighing up to 27 lbs. within short distances in the work area, and be able to bend and stoop as needed. the job requires a signiificant amount of local and regional travel. If interested in this position please apply or referred to a friend. As the local offices of Kelly Services do not represent the above position, please apply on-line for immediate consideration. For questions regarding this position, please contact About Kelly Services ® Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion. [Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ? , a free career and employment resource iPad® app by Kelly Services.] iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Connect with us on...

Process Engineer

Responsibilities The Process Engineer is responsible for providing process engineering support to the company The Process Engineer is responsible for developing mathematical models to simulate fermentation and chromatography unit operations The Process Engineer is responsible for performing experiments to verify accuracy of model The Process Engineer is responsible for reviewing design documents related to procurement of new equipment The Process Engineer is responsible for performing testing and operation of bioprocessing equipment The Process Engineer is responsible for writing reports required for tech transfer The Process Engineer is responsible for evaluating performance of new technologies The Process Engineer is responsible for working in the laboratory environment The Process Engineer is responsible for working independently to provide support on upstream/downstream facility fit, process technology transfer and process validation. Provide process troubleshooting during scale-up and engineering runs. Provide process subject matter expertise and ownership of assigned deliverables to further the project objectives. The Process Engineer is responsible for leading cross-functional meetings and professionally represent the MS&T department. The Process Engineer is responsible for working effectively in highly cross-functional project teams, matrix management environments and working independently to accomplish project goals. The Process Engineer is responsible for interfacing with Manufacturing, Quality, Engineering, and internal MS&T departments at multiple sites throughout the company?s network...

Sr. Process Development Engineer

For more than 40 years, Entegris has been a provider of critical products and materials used in advanced high-technology manufacturing. These products and materials are often used to make the building blocks of many of the world's most complex microelectronic products, such as computers, mobile devices and phones, data storage components, televisions and monitors, and automobiles. Headquartered in Billerica, Massachusetts, Entegris employs approximately 3,500 people worldwide, with roughly half employed in Asia-Pacific or Europe. With research and development, customer service, analytical labs, and manufacturing in Asia-Pacific, North America, and Europe, Entegris supports customers around the globe as they take technology to the next level. Overview: Entegris is seeking a Sr. Process Development Engineer for our Billerica, MA facility. You will be responsible for leading process design and development projects in support of a broad range of new liquid filtration & purification products used in fabrication of semiconductors. Responsibilities: Work closely with New Product Development and Marketing to ensure Product Requirements are realized though the developments of capable processes; Support New Product Introduction throughout the Staged Gate process by executing the required Process Development deliverables;Understand market and industry roadmaps to develop advanced cleaning and assembly technologies ahead of the requirement; Champion the integration of automation, SPC and design for Six Sigma in all new processes;Research and understand competitive products and technologies;Transfer of knowledge and capabilities to both Continuation Engineering and Manufacturing as products/processes mature into Pilot Production and eventual HVM; Support the pre-pilot production of new products and alpha samples to key customers as needed to seed the market; Work with Applications Engineering and Product Managers to generate detailed reports, data packages and technical papers to support the performance of new products; As a project leader, drive ambiguous point to clarity while providing action plans/recommendations to deliver on complex, difficult, and sometimes under defined goals; Analyze requests vs existing technology to assess technical feasibility, cost , time and required resources to complete projects; Identify, test and recommend opportunities to improve legacy processes vs developing new ones when appropriate; Perform administrative functions such as writing monthly status reports, expenditures and other documentation....

Sr. Software Engineer

Job Description: Our client is looking for a Sr. Software Engineer to add to their team. As a Scrum Team Member, the this role will play a key role in the design, development, and testing of products delivering to our product roadmap. Senior Software Engineers collaborate with peers and Medical Imaging for product planning and implementation; mentoring other staff; process improvement and other related engineering duties as required. The Senior Software Engineer may employ a variety of programming languages and related technologies with a specialty in a particular space relevant to Medical Imaging such as Enterprise Java/web applications or client/.NET applications. The Senior Software Engineer will also be expected to research changes in development environments and technical direction, offering ideas and suggestions and detailing information regarding updates to the development tool set, technical direction and software design. The position participates in a team of software engineers and requires adherence to FDA regulations such as 21 CFR Part 11 and GCP. Key Accountabilities: ? Perform the analysis, design, coding and testing of complex enhancements to the Medical Imaging product suite, providing technical solutions that conform to requirements. ? Investigate new technology and updates for their impact on development and ensure that the team is aware of any technical changes that need to be implemented. ? Provide assistance to scrum teams and Engineering Management team for estimation, work allocation of development tasks/ activities and technical updates. ? Investigation of issues reported both internally or through support and identification of solutions to those issues. ? Support the organizations business strategy and decision making process, make professional decisions regarding trade-offs between optimal technology and optimal delivery in context of business, marketing and client needs. ? Responsible to the Medical Imaging Engineering management team for the progress and implementation of complex development tasks to costs and timescales. ? Participate in Agile Project & Task Planning as well as Status Reporting ? Development and adherence to the Medical Imaging SDLC and published programming standards Job Qualifications: ? Strong programming skills a must. ? Experience with the following - o Server side Java technologies such as J2EE, Servlets, JSPs, tag libraries, JMS etc. Frameworks and libraries such as JUnit, Wicket, Struts, easyB, Spock, Spring, Hibernate, JPA, JDBC, XML, Maven, Gradle, Groovy, SOA, REST. ? Demonstrable competence developing commercial grade software systems. ? Solid object oriented design skills and competent application of design patterns, experience designing multi-threaded applications. ? Detail oriented, flexible, and works well in a team-oriented environment. Ability to work in deadline driven environment. ? Desired - experience with one or more agile development methodologies (e.g. RUP, SCRUM, XP) Education: ? Bachelor of Science or Bachelor of Arts in computer related field, or equivalent work experience. Minimum Work Experience: ? 5+ years of working in a professional software development environment ? Desired - Experience in bio-medical, medical imaging, and clinical trials data management ? Desired - Experience of working in a 21 CFR Part 11 FDA regulated environment (typically gained over 3 years or more)...

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