Biomedical Engineering Career Careers in the United States

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Biomedical Technician

CSI Healthcare IT is currently searching for multiple Biomedical Technicians for one of our renowned Healthcare clients in the Orlando, FL area. This will start off as a 4-6 month contract with potential to go contract-to-hire. Pay rates will be $13.00-$24.00/hour, based on experience. The Biomedical Technician will be going from site to site doing inventory. If interested in this role, please apply with an updated resume....

Electronics Technician / Engineer - Biomedical Equipment Repair

Immediate Opening for Experienced Engineer LOCAL BIOMEDICAL EQUIPMENT SERVICE COMPANY SEEKS PM AND SERVICE PERSONNEL TO MAINTAIN AND REPAIR MEDICAL EQUIPMENT IN HOSPITALS, NURSING HOMES, CLINICS AND OTHER HEALTHCARE FACILITIES MUST HAVE A BACKGROUND IN BIOMEDICAL EQUIPMENT REPAIR, TESTING AND PREVENTIVE MAINTENANCE. BIOMEDICAL EQUIPMENT REPAIR TECHNICIANS (SUPERVISORY POTENTIAL) We Accept Applicants Holding H1B Visas. Experienced Biomedical Technicians: should have medical equipment background. Will consider military or technical school graduate with a degree in electronics and related experience. Biomedical Field Service Technicians needed to perform inspections, preventive maintenance and repair medical equipment for health care facilities in the Greater New York Metropolitan area. We are a growing, Independent Service Organization (ISO) specializing in Nursing Homes, Hospitals, Clinics, Physician and Physical Therapy Practices. Applicants should have a career (long term) objective to grow with the company. A BMET certification is a plus. Requirements Should be customer oriented Have experience servicing a broad variety of medical equipment `including general biomedical, enteral pumps, diagnostic and physical therapy equipment, etc. An Associates or Bachelors degree in biomedical engineering, clinical engineering or electronics (or military training) or related work experience. Note: Training will be provided on equipment with which applicant is not experienced....

Biomedical Technician (BMET)

Imaging BIOMEDICAL ENGINEERING TECHNICIAN (BMET) (General Medical Equipment) STATEMENT OF WORK MSS is looking for an Imaging Technician for one of our clients hospitals in Philadelphia . The Imaging Technician is responsible for troubleshooting, repairing, and calibrating basic radiology equipment. In addition to responding to service requests and completing maintenance inspections, this person manages basic projects which consist of coordinating and planning small system installations, following up with equipment recalls, and interacting with Providers and other clinical staff to lessen operator error and reduce equipment malfunction. The Imaging Technician works closely with the Medical Physics Department to ensure all equipment meets state/federal guidelines for radiation producing equipment. Position requires a high level of customer service skills in order to establish and enhance positive relationships with patients, co-workers, and others. COMPANY PROFILE MSS Services, Inc. is a SBA Certified 8(a) Small Disadvantaged Business consisting of highly skilled professionals who specialize in the management, administration, engineering, construction management, operation and maintenance of client facilities. We deploy the talents of our staff either individually or in a team format at the client facility in support of a specific need or range of needs as they are defined by the client's scope of work. Some examples include deployment of supplemental professional talent (i.e. Project Managers, Construction Managers, Engineers, Architects, Biomedical Engineers and Technicians, Project Controls Specialists, Contracts Specialist) to provide day-to-day care and oversight of building systems and to achieve the specified scope of work activities. http://www.mssserv.com/...

Biomedical Engineering Manager

GreatBiomedical Engineering Opportunity - Greater Philadelphia Area Company Information My client is a global leader in providing professionalservices to the Healthcare Industry. They are currently seeking a skilled Technology Manager in the GreaterPhiladelphia Area to serve with a regional hospital. Provides overall planning, direction, and control of the CTS program Supervise and coordinate activities of biomedical equipment technicians Utilize knowledge of computer, electrical, and mechanical engineering principles with other related technologies Analyze departmental budget to identify needs and may allocate operating budget funds Interpret company policy, specifications, blueprints, and job orders to employees while enforcing safety regulations Provide solutions to work problems and assists subordinates in problem resolutions Recruit, hire, train staff, employee evaluations, and initiate promotions, transfers, and disciplinary action...

BIOMEDICAL REPAIR TECHNICIAN III

Job Description: BMET III - COUDERSPORT PA 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 at hospitals in your region, 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. Manage equipment and schedule service. Perform pre-acceptance inspections and develop PM procedures on newly purchased equipment; maintains files on procedures and manuals. Ensure test equipment is working properly and calibrated within established intervals. Respond expeditiously to calls from clinical departments to evaluate and rectify valid operator complaints and concerns. 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 Systems Engineer

This newly created Biomedical Systems Engineer role offers you the opportunity to help develop new dynamic imaging solutions that leverage leading edge technology , as part of Canon's ongoing expansion in medical imaging. You will develop products that enhance or support the usage of Canon digital detectors, designing new modalities to enhance the technology and expand our product portfolio. In addition, you will support new, emerging technologies, working with them before they are widely known or available . You may think "camera" or "copier" when you hear the Canon name, but we also have the largest installed base of detectors worldwide, commanding a market share almost twice as large as our nearest competitor. Your success in this role could set you up to pursue promotional opportunities in engineering or management. To meet the basic qualifications for this role you will have a verifiable bachelor's degree or higher. To be a good fit or the Biomedical Systems Engineer opportunity, you also should have: Five to seven years of experience in biomedical systems engineering, preferably including imaging equipment A demonstrated understanding of complex biomedical systems and how all the components work together Experience in regulated environments (UL, ETL, FDA, etc.), such as preparing documentation of regulatory compliance Strong communication skills and the ability to partner/collaborate with cross-functional project teams Virtual Imaging, Inc., located in Boca Raton, Florida, is a wholly owned subsidiary of Canon U.S.A., Inc. Combining broad experience, extensive resources, and broad business functions, Virtual Imaging provides high-quality, productivity-enhancing digital radiography (DR) solutions that help care providers accelerate exams and maintain productive workflow. Canon U.S.A., Inc. is a leading provider of consumer, business-to-business, and industrial digital imaging solutions. With approximately $38 billion in global revenue, its parent company, Canon Inc. ranks third overall in U.S. patents registered in 2013 (based on weekly patent counts issued by United States Patent and Trademark Office) and is one of Fortune Magazine's World?s Most Admired Companies in 2014. EOE/AA/M/F/Vets/Disabled...

Biomedical Eng

Biomedical Eng (US-Brazil)(Doral, Florida) report and dev all technical and regulatory needs for production of electroencephalograph machinery produced by parent company in Brazil; enhance the company's products, process and infrastructure; use software and math models to design, develop, and test new materials,devices, and equip; daily contact with manufact, qual control, purchasing and marketing depts in Brazil reqs: BS in Biomedical Eng plus two years exp in lieu of a Bach degree and two years Exp emp will accept fours yrs exp in position offered. Fluency in Portuguese. Must have Knowl of Electroencephalography and Polysomnography clinical processes and FDA,INVIMA,AND ANVISA compliance. Emp will accept any suitable comb of edu, training,and exp. Send resume to: Ed Faria, Neurovirtual USA, Inc. 2315 NW 107th Avenue #27,Doral FL 33172 Source - Miami Herald...

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....

EG50 - Sales Engineer - Biomedical

Sales Engineer - Biomedical Job Description Summary: - To maintain and expand relationships with important large medical OEM customers. - To represent the entire range of company products and services to assigned customers. - Lead the customer account planning cycle. - Ensure that assigned customer needs and expectations are met. - Manage assigned key customer accounts. Knowledge/Skills: - Must be able to reprioritize activities as a function of current/previous tasks. - Must be comfortable working on several tasks in parallel. - Must be able to maintain composure in the achievement of aggressive performance targets and project deadlines. - Knowledge in medical imaging/instrumentation business, including regulatory affairs. - Direct selling experience of critical component parts to larger OEM's in the medical diagnostic sector. - Experience working in Asian markets, especially Korea and China?Europe a plus. - Must have the ability to operate in a fast paced and dynamic environment. Qualifications ? Education/Experience: - Bachelor of Science in Science or Engineering. MBA a plus. - Minimum of 5 years strategic sales experience in a medical business-to-business sales environment. - Establishes productive, professional relationships with key personnel in assigned customer accounts. - Coordinates the involvement of company personnel, including support, service, and management resources, in order to meet account performance objectives and customer expectations. - Proactively leads joint company-strategic account planning process that develops mutual performance objectives, financial targets, and critical milestones for a one and three year period. - Proactively assesses, clarifies, and validates customer needs on an ongoing basis. - Leads solution development efforts that best address customer needs, while coordinating the involvement of all necessary company personnel. - Internally communicates sales pipeline including sales forecasts. - Provides training and support assistance over the telephone or in person as required. - Must be able to travel extensively. Up to 25% international travel expected. - US Citizenship or permanent resident required. Why Kelly ® ? Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests. 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....

Field Service Engineer - Anesthesia Specialist

Field Service Engineer - Anesthesia Specialist **This position is located in Denver, CO Relocation Assistance is Available** Colorado has more than 340 days of sunshine. Improve Your Quality of Life Colorado offers a wide range of out-door life enhancement activates: skiing, boarding, cycling, jogging, walking, white water rafting, hand gliding, hiking, off-roading, horseback riding, mountain climbing, snowshoeing?? Come live where life is better, COLORADO ! Full job descriptions are available on the HSS website-- http://hss-us.com Position Summary The goal of the Field Service Engineer as part of our Medical Equipment Management (MEM) Team is to provide excellent customer support for HSS customers and their mission. This position completes repairs, service work, and preventative maintenance for a variety of GE anesthesia delivery systems in accordance with established HSS policies and procedures. Works with a high degree of autonomy and provides a high level of customer service. This position is based at a nationally renowned specialty hospital. Essential Duties & Responsibilities ? Performs service work and preventive maintenance of medical equipment and ensures completion of the percentage requested by customers. ? Repairs equipment as needed including: failure assessment, parts orders, delivery back to customers, and keeping customers informed of status. ? Resolves issues pertaining to the medical equipment and works with customers to ensure medical equipment and technology is working within specifications. ? Accurately documents and keeps detailed records of all work related activities. ? Performs scheduled inspections. ? Provides customer support of non-PM and non-repair issues such as following up on customer questions, attending meetings, and research issues. ? Provides all other support as requested by manager. ? Works and interacts with current and prospective clients, other employees, sales representatives, vendors, medical personnel, patients, guests, and visitors. ? Other duties as assigned. Other Duties & Responsibilities Stays abreast of changes in medical equipment technology....

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,...

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....

Sr. Mechanical Engineer, Ultrasonics IRC6685

The Senior Mechanical Engineer, Ultrasonics contributes to research and new product development of medical ultrasonic systems thereby advancing the standards of care and ensuring existing platforms support new clinical solutions via continued realization of enabling technologies. Responsibilities include technical contribution with knowledge of mechanical or biomedical engineering, and demonstrated proficiency in advanced mechanical design, finite element analysis, and simulation tools. TOOLS AND EQUIPMENT USED Knowledge of engineering change system. Knowledge of engineering documentation. Knowledge of engineering test protocols. Knowledge of Product Development Process (PDP). Knowledge of engineering laboratory procedures. Knowledge of Purchasing Department procedures. Skills in personal computer spreadsheet, word processor and engineering tools. Ability to carry out engineering calculations and analysis. Ability to write engineering documents, test protocols, laboratory notebook entries and reports. Ability to perform component engineering designs and changes. Ability to operate light machine tools and laboratory instruments. Ability to interpret displayed results on laboratory instruments. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Contributes to mechanical design of components, sub-assembly and assembly using in-depth knowledge of materials and processes to meet extremely challenging technical requirements. Contributes in all Mechanical Engineering aspects of Ultrasonics R&D within project teams, specifically in Mechanical Design, Solid Modeling, and Finite Element Analysis. Must be expert in Pro-Engineer drawing tools, and exact in translation of solid models. Works from first principles in engineering ultrasonic surgical instruments and systems. Designs and test prototype ultrasonic surgical horns, mechanical components and systems. Performs modeling, simulation, and FEA (Finite Element Analysis) of components and assembled systems using Pro-Engineer/Creo, Pro/Mechanica. Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements. Develop verification test criteria and test plans that demonstrate design success. Takes leadership role in V&V testing of surgical instruments and systems. Work in laboratory with biologic tissue and observations in clinical settings and the operating room are necessary. Create and maintain detailed component and assembly level drawings that specify critical features, materials, and tolerances using GD&T as required. Perform in depth tolerance stack-up analysis using fundamental principles or advanced techniques like Monte-Carlo simulations as required. Works and interacts closely with external partners, vendors and design firms as needed. Executes according to project priorities, schedules, and plans. Interacts with laboratory technicians and other engineers on tasks in a leadership role. Provides extensive engineering documentation of test and analysis results in support of development, intellectual property, regulatory, and validation requirements. Prepares presentations for team and various company meetings. Develops and writes specifications for components, systems, and new products.Follows all safety procedures. Travels as needed to domestic and international vendor sites, company locations, and clinical settings....

SR SCIENTIST/ENGINEER

Title: SR SCIENTIST/ENGINEER Job Type: Contract (1 Yr.) Location: Raritan, NJ SR SCIENTIST/ENGINEER, Product Development Cell Isolation - Raritan, NJ. The Senior Scientist/Engineer position, Product Development will be working as part of a multi-disciplinary team and be responsible for development of new techniques, instrumentation, and consumables in the areas of immunofluorescent cell labeling, single cell picking and fluorescent microscopy during feasibility and development. The candidate will be independently responsible for the conception, design, implementation and interpretation of scientific research projects pertaining to the staining/labeling, identification and isolation of single cells. The candidate will be required to conduct experiments on early consumables and prototype/breadboard fixtures in an effort to refine requirements and identify areas of risk and mitigations for those identified areas. Additionally, the individual may be required to assist in similar activities for other subsystem areas depending on the nature and complexity of the feasibility and integration activities. The successful candidate will develop the strategy, test plans/protocols and reports for feasibility and integration activities to be compliant with regulatory requirements, and Pharmaceutical procedures. He/she will be providing direction to other team members who will be responsible for executing test designs along with the candidate, and performing the data analysis/evaluation to draw conclusions and write reports associated with the activities. This person will be responsible for effectively interacting with people representing a broad array of technical specialties to achieve success. He/She will be responsible for thinking broadly, unconventionally and being open to new ideas from others. Qualifications A minimum of a Master s degree ( PhD preferred) in Biology, Cell Biology, Molecular Biology, Chemistry or Biomedical/Chemical Engineering is required. At least 5 years experience working in a laboratory or medical device industry is required. Experience in the fields of cell picking or cell labeling and analysis is required. Experience in surface chemistry and buffers related to cell isolation is a big plus. Experience in the fields of flow cytometry, cell culture, molecular biology and Immunology is desired. Experience in antibody conjugationand antibody screening is a plus. Experience working with the FDA on 510K s and design control process for Medical Device is a plus. Experience working at a fast past and on early-stage ambitious programs, such as in a startup environment, is desirable. Must have a strong knowledge of statistics, especially related to Design of Experiments (DOE) and excellent technical writing skills....

Instrument Engineer

SensiQ Technologies in Oklahoma City is growing and has an opening for an instrument engineer. Qualified candidates should have a BS or MS in mechanical engineering or biomedical engineering. CAD experience required, Solidworks design experience preferred. Both manufacturing and development experience preferred. Some US and International travel is required....

Senior Engineer, New Product Development

Job is located in Warsaw, IN. 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...

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....

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:...

Field Service Engineer

Aerotek is looking for a Field Services Engineer to help conduct preventative maintenance and service calls for medical equipment in a hospital setting. This is a 6 month, CTH. JOB DESCRIPTION: - Perform PMs and service calls on a variety of medical equipment (defibrillators, patient monitors, pumps, etc.) - Properly document all PM calls and service calls according to policy and procedures - Make calls to order parts for various items throughout the hospital - Work directly with the BioMed at the hospital to locate equipment and repaird equipment - Perform various routine tasks associated with the installation, service, and calibration of a diverse range of biomedical equipment and instrumentation - Assist in the support of a systemativ preventative and corrective maintenance program for biomedical equipment and instrumentation - Install, qualify, maintain service, modify, troubleshoot, safety test, and calibrate a variety of biomedical equipment About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit Aerotek.com ....

Engineering Technician

BELCAN is a global provider of engineering services to the Gas Turbine, Semiconductor, and Biomedical industries. Are you a highly motivated engineer looking to contribute in the Biomedical Engineering Sector? We are currently seeking an Engineering Technician in Warsaw, Indiana. Job Duties - Job focus relates to maintenance plans for biomedical tooling - Multitasking projects. - Perform root cause analysis, process qualification, and validation. - Documentation review and report writing. - Work in a shop/factory environment; standing for most of the day. - Read and understand SOPs, regulations, work instructions, product manuals, etc. - Troubleshooting equipment and processes. - Set up experiments and validation tests. - Potential part-time travel - Working some extended work hours when required. Job Qualifications - Must have a 4 year degree in Mechanical, Industrial, or Manufacturing Engineering - New college graduate is acceptable. - UGNX/Teamcenter knowledge a plus - Experience with manufacturing desired. - Experience in medical facility or laboratory environment desired. - Ability to lift 35 pounds on occasion. - Must be comfortable with operating industrial machinery. - Must have experience with performing and documenting experiments. - Must be able to work on a team or independently. - Must have experience with Microsoft Office Products. - Any experience working in a medical facility or laboratory environment is strongly desired. - Must be capable of drawing mechanical sketches and concepts sufficiently to convey ideas and thoughts to customer. - Must have good presentation skills and capable of preparing and editing MS PowerPoint presentations. * Due to the nature of the work being done applicants must be U. S. Citizens. Work would be performed in Warsaw, Indiana and would be 10 months in duration starting September 2014. Please email your resume to Belcan is an equal opportunity employer....

Research Assistant

Magnetic Resonance Innovations, Inc . has an available position of Research Assistant in Detroit, MI. Position requires a Master's degree in Biomedical Engineering & 6 months experience as a university research assistant &/or biomedical imaging engineer. Position also requires: Exp. must include: 1) Exp. performing magnetic resonance (MR) image analysis; 2) Exp. utilizing compressed sensing technique for high resolution vascular imaging & susceptibility mapping; 3) Exp. evaluating the tissue properties & visual pathways of the brain. Any exp. reqs. may be met concurrently during the same 6-month period. Job duties: Conduct magnetic resonance imaging (MRI) research to study structure & function of the human brain. Perform image processing for detection of cerebral microbleeds. Study the tissue properties & visual pathways of the brain from the eyes to the Optic Radiation. Evaluate the vasculature of the brain as related to a number of neuro-degenerative diseases including Multiple Sclerosis, Stroke, Alzheimer's, & Parkinson's. Publish/present results of research. Qualified applicants should send resume & verification of reqs. to Rachel D. Martis-Laze, Administrator, Magnetic Resonance Innovations, Inc., 440 East Ferry Street, Detroit, MI 48202....

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...

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...

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....

Student Intern - Supplier Quality Engineering

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 Student Intern to work with our Supplier Quality Engineering group. Responsibilities Primary job responsibilities include supporting Supplier Quality Manager(s) in the following projects/tasks: Supplier Quality Database development, implementation, and maintenance Supplier Scorecard & Dashboard development, implementation, and maintenance Supplier Scorecard & Dashboard metrics and data analysis Supplier & Product Risk Classification development, implementation, and maintenance Supplier Audits scheduling, documentation, and follow-up activities Supplier Corrective Action Report documentation and follow-up activities Supplier Non-Conformance Issue investigation, analysis, and resolution Supplier Self-Assessment documentation and follow-up activities Supplier Business Agreement & Contract documentation and follow-up activities Successful candidate(s) will be exposed to learning Advanced Product Quality Planning (APQP). The APQP process has seven major elements: (1) Understanding the needs of the customer (2) Proactive feedback and corrective action (3) Designing within the process capabilities (4) Analyzing and mitigating failure modes (5) Verification and validation (6) Design reviews (7) Control special / critical characteristics. Qualifications &Skills include: Sophomore, Junior, or Senior majoring in Bio-Medical Engineering, Chemical Engineering, or other Engineering disciplines Strong interest in working with Supplier Quality Engineering & Procurement processes Strong Microsoft Office Suite skills ? Access, Excel, Word, and PowerPoint Strong Problem Solving & Analytical skills Strong Interpersonal & Communication skills Able to work well in a Project Team environment 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 (EEO). *CB*...

Production Planner-Operations Engineer

The Production Planner-Operations Engineer will have 2 to 10 years? experience working within the medical device or pharmaceuticals manufacturing industry . This person will oversee the entire warehouse operations plan for the next 6 months. This person will handle planning, logistics, and the entire flow systems process. Develop and execute the manufacturing production plans and schedules to assure timely flow of materials and finished goods to meet demand for product. The planner must liaise with sales/marketing, clinical, internal customers, purchasing and manufacturing to balance supply and demand. The planner also generates general and detailed reports related to product demands, shortages and manufacturing warehouse performance. Keys: Manufacturing/Production/Operations - Production Planning?Operations Engineering, planning both short & long term, logistics, manufacturing systems, etc. Knowledge of MRP inventory control, and/or ERP, SAP, JD Edwards, etc. This position requires US Citizenship. This position requires a B.S. Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Aerospace Engineering degree and/or other technical science degree. M.S. degree is a plus. If interested & you meet the requirements please send a copy of your resume as a word doc attachment to . Steve Moore direct line 484 567 2081. Code: liberty123...

Quality Engineer - Entry-Level

Great Opportunity for Entry Level & Recent Engineering Grads! Currently hiring entry-level Quality Engineers for a Remediation Project for a global medical device company. Gain high-level exposure to and training for a very successful, well known, and growing Engineering team. We are looking for Medical Device Quality Engineers to learn our process and procedures and help make our products better. Our Quality Engineers work with industry changing products. Communication is critical! This position will work daily with fellow engineers and our assembly line personnel to ensure non-conformant reports (NCRs) are investigated, root cause is found, and corrective actions are identified; then implemented. We look for problem solvers who know how to get things done. Responsibilities: Participate and perform equipment process optimization and validations. Participate and perform discrepant material disposition. Update existing inspection plans, test methods, and standard operating procedures. Participate in sample size determination, statistical analysis, training, and root cause analysis. Participate in process failure modes and effects analysis (FMEA). Participate in various manufacturing projects such as process development, cost reduction and quality improvement initiatives. Collect, review, analyze, and trend quality indicators for monthly and quarterly reviews. Participate in problem solving teams using standardized investigation processes/tools....

Part Design Engineer

Biomedical manufacturing company currently seeking a Part Design Engineer to join their team in the Stockton, CA area. This is an exciting opportunity to join a small, well-established company that offers competitive pay and benefits. As the Part Design Engineer you will develop medical plastic parts using SolidWorks and AutoCAD. The Part Design Engineer will work closely with the Engineering team and is an essential member of the company....

Process Technician ? Pharmaceuticals ? 2nd Shift

Processing Technician ? Pharmaceuticals ? 2nd Shift Norcross, Georgia in the greater Atlanta area At Immucor, we are a company in the biomedical technology field that has a history of innovating to improve transfusion medicine and transplantation diagnostics. We have two business units now: Transfusion Diagnostics, which includes our traditional serology products; and Transplant and Molecular Diagnostics, which includes the BioArray Solutions and LIFECODES products. We are currently seeking a Red Cell Processing Technician to join our Red Cell Processing team. This is a certified ACT National Career Readiness (formally Georgia Work Ready) position. It is preferred that applicants have a WorkKeys Gold Level ACT National Career Readiness Certificate (NCRC). In this role you will process red blood cells, formulate red blood cell products into a diluted (bulk) state, and perform in-process testing in an aseptic production environment. The scheduled shift is 2nd shift, Monday - Friday. Processing Technician ? 2nd Shift - Pharmaceuticals Job Responsibilities As a Red Cell Processing Technician, you will perform your production tasks in a clean-room environment. In addition, it will be your responsibility to ensure that your work is consistently in compliance with Good Manufacturing Practices and Good Documentation Practices. The scheduled shift is 2nd shift, Monday - Friday. Your specific duties as a Red Cell Processing Technician will include: - Performing blood processing operations according to corporate policies, operating procedures, specifications, and verbal work instructions - Ensuring that blood products are transported, processed and stored in a manner that prevents contamination - Following appropriate control measures to prevent mixing of dissimilar production components in compliance with Good Manufacturing Practices - Performing in-process testing and visual inspections of product for defects - Creating legible written processing records that initiate product Batch Records and comply with all procedures and Good Documentation Practices - Following applicable laboratory & OSHA regulations with respect to hazards and blood-borne pathogens - Maintaining a neat, clean and orderly work environment - Independently performing equipment setup, operation, re-supply, documentation, cleaning, minor adjustments and minor maintenance tasks to meet standards for safety, quality, reliability, and efficiency - Applying FDA regulations and ISO standards to department operations and understanding consequences of non-conformance - Moving, storing and inventorying production supplies and materials according to department specifications - Completing all training and qualification requirements and actively participates in ongoing training as well as in the training of new employees - Assisting and communicating with co-workers to ensure that all safety, quality and efficiency objectives are achieved - Demonstrating supportive behaviors towards co-workers and cooperating as a member of the team - Demonstrating behaviors supportive of personal and professional growth of self and co-workers - Being available for temporary assignment to other areas, either for skills development or to support company needs Red Cell Processing Technician ? 2nd Shift - Pharmaceuticals...

RBC Process Technician

Processing Technician ? Pharmaceuticals ? 2nd Shift Norcross, Georgia in the greater Atlanta area At Immucor, we are a company in the biomedical technology field that has a history of innovating to improve transfusion medicine and transplantation diagnostics. We have two business units now: Transfusion Diagnostics, which includes our traditional serology products; and Transplant and Molecular Diagnostics, which includes the BioArray Solutions and LIFECODES products. We are currently seeking a Red Cell Processing Technician to join our Red Cell Processing team. This is a certified ACT National Career Readiness (formally Georgia Work Ready) position. It is preferred that applicants have a WorkKeys Gold Level ACT National Career Readiness Certificate (NCRC). In this role you will process red blood cells, formulate red blood cell products into a diluted (bulk) state, and perform in-process testing in an aseptic production environment. The scheduled shift is 2nd shift, Monday - Friday. Processing Technician ? 2nd Shift - Pharmaceuticals Job Responsibilities As a Red Cell Processing Technician, you will perform your production tasks in a clean-room environment. In addition, it will be your responsibility to ensure that your work is consistently in compliance with Good Manufacturing Practices and Good Documentation Practices. The scheduled shift is 2nd shift, Monday - Friday. Your specific duties as a Red Cell Processing Technician will include: Performing blood processing operations according to corporate policies, operating procedures, specifications, and verbal work instructions Ensuring that blood products are transported, processed and stored in a manner that prevents contamination Following appropriate control measures to prevent mixing of dissimilar production components in compliance with Good Manufacturing Practices Performing in-process testing and visual inspections of product for defects Creating legible written processing records that initiate product Batch Records and comply with all procedures and Good Documentation Practices Following applicable laboratory & OSHA regulations with respect to hazards and blood-borne pathogens Maintaining a neat, clean and orderly work environment Independently performing equipment setup, operation, re-supply, documentation, cleaning, minor adjustments and minor maintenance tasks to meet standards for safety, quality, reliability, and efficiency Applying FDA regulations and ISO standards to department operations and understanding consequences of non-conformance Moving, storing and inventorying production supplies and materials according to department specifications Completing all training and qualification requirements and actively participates in ongoing training as well as in the training of new employees Assisting and communicating with co-workers to ensure that all safety, quality and efficiency objectives are achieved Demonstrating supportive behaviors towards co-workers and cooperating as a member of the team Demonstrating behaviors supportive of personal and professional growth of self and co-workers Being available for temporary assignment to other areas, either for skills development or to support company needs Red Cell Processing Technician ? 2nd Shift - Pharmaceuticals Job Requirements As a Red Cell Processing Technician, you must be highly motivated with a strong work ethic. You must also be very detail-oriented and organized, with excellent time-management and multitasking skills. It is also important that you display excellent verbal and written communication and interpersonal skills, along with the ability to speak effectively before groups of customers or employees. Prior experience working in an aseptic environment is preferred. The scheduled shift is 2nd shift, Monday - Friday. Specific qualifications for the Red Cell Processing Technician position include: Associates Degree in Life Science required; Medical Technology Degree preferred. 1 -3 years of current experience in Blood Banking/Transfusion Medicine preferred or related industry. WorkKeys Gold Level ACT National Career Readiness Certificate (NCRC) preferred MUST be able to accommodate production requirements that may require 50+ hour workweeks, including extended day hours and weekends. Experience working in an aseptic environment preferred. Ability to complete courses and/or assessments related to aseptic technique and gowning and to then work while aseptically gowned in a clean room environment and maintaining personnel environmental monitoring results within specifications Ability to work irregular hours and days as necessary in order to meet production schedules Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals Ability to write routine reports and correspondence Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume Ability to apply concepts of basic algebra and geometry Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form Ability to deal with problems involving several concrete variables in standardized situations Ability to lift up to 50 pounds Red Cell Processing Technician ? 2nd Shift - Pharmaceuticals IMMUCOR, INC IS AN EQUAL EMPLOYMENT OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY/FEMALE/DISABILITY/VET; *DRUG FREE WORKPLACE RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECRUITMENT FIRMS WILL NOT BE CONSIDERED....

Verification Test Design Engineer

RESPONSIBILITIES: Kforce has a client seeking a Verification Test Design Engineer for their office in Lake Oswego, OR. This resource will ensure that our biomedical device design conforms to product specifications. The ideal candidate is experienced in developing new test methodologies as well as test development and execution for extremely low power embedded, real time applications. Duties: Develop and execute automated software verification tests (written in C# language) for each work product to ensure the device conformance to the specified requirements Analyze test results with specific focus on hardware/ firmware interactions Review test procedures generated by associate software verification engineers Review product requirements documents and product design firmware (written in C language) Generate protocols, guidelines and training sessions for the Software Verification team on proper verification test designs Follow structured product development lifecycle in the medical device regulated environment May serve as verification lead on projects and generate guidelines, protocols and training sessions for the software verification team Normally receives little instruction on daily work assignments Foster a culture of continuous process improvement and provide technical mentoring and coaching to software verification engineers...

Materials Engineering Manager

Quadion, LLC is a leader in providing precision-made rubber, silicone, and plastic components and assemblies. Throughout our global operations, our focus is on creating value for our customers by providing outstanding technical and manufacturing services. From design and materials engineering to customer support, we demonstrate our commitment to excellence in the quality and performance of the products we sell. We offer excellent benefits, including medical, dental, vision, life, and disability, as well as a 401(k) plan. We are seeking a Technical Leader Advanced Materials Group POSITION OBJECTIVE : As a technical leader overseeing a team of chemists / engineers serving Medical, Automotive, Fluid Delivery, and Fluid Power vertical markets, you will be responsible to make sure that all material development and or improvement projects are meeting business and operational goals. The intent of this position is to be a working leader i.e. a player coach who leads by example and is a global focal point for all material development related topics. Reporting to the Senior Director of Advanced Materials Group, the Materials Engineering Manager will be a critical member of the overall R&D leadership team and is responsible for leading the development of the Company?s unique material compounds. ACCOUNTABILITIES: Oversee and direct activities related to rubber and elastomer formulation development projects, plant support, and customer support with overall responsibility for the direction of those assigned areas. Provide functional and project vision and leadership for the team toward setting and meeting business goals. Lead implementation of advanced formulation design and compounding methodologies, techniques, and evaluation criteria. Responsible for cross functional collaboration with manufacturing operations, marketing, sales, quality, and regulatory functions. Coach and develop team members towards meeting personal and corporate objectives. Mentor chemist resources in support of technological, product and system requirements. Develop annual performance objectives for team and direct reports, and ensure annual performance reviews are conducted on a timely basis. Provide cost center planning and management Create and manage key internal and external partnerships, including relationships with customers, vendors and contract service firms. Forecast and assign resources based on business knowledge under the stress of dynamic business conditions to ensure efficient utilization to meet company objectives. Act as team member for developing and continuously improving material development process and staff Ensure commitment to functional excellence and the ability to execute positive changes....

Sr. Process Improvement Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Our client is a midsized yet growing medical device organization with market leading products. They have a new facility, great benefits as well! Essential job responsibilities include, but are not limited to: Responsible for leading projects to improve quality and efficiency of manufacturing processes. Also responsible for leading the scale-up, validation, and transfer of new products into manufacturing. Responsibilities include: designing, executing, and documenting experiments, guard-band studies, generating Operations documentation for new products and validation of new processes and equipment....

Principal Engineer

JOB TITLE: Principal, Engineer At Cardinal Health, we?re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. Function: Engineering Family: Mechanical Engineering What Mechanical Engineering contributes to Cardinal Health Mechanical Engineering is responsible for designing and developing components, mechanisms, systems and finished products or equipment. What is expected of you for success in your role Project management of complex product development initiatives Demonstrated use of best practice methodologies such as a stage gate process to drive project from concept to commercialization. Establishes product requirements based on customer needs; verifies design output meets design input Demonstrates advanced knowledge of engineering principles in solving moderately complex technical problems Drives the intellectual property strategy for product development initiatives Supervises at least one junior engineer; provides constructive development feedback, guidance on projects, and day-to-day training and assistance. Leads project tracking efforts for large team of engineers, escalating issues and updates to management and providing guidance to team as needed....

CAE Analyst

Position Summary: The successful candidate will support and lead the design and development of medical devices through the use of computational methods such as finite element analysis (FEA) and computational fluid dynamics (CFD), while working within an interdisciplinary team of engineers and scientists evaluating novel design concepts for new medical products. Support of experimental activities to confirm device performance, as well as support of the regulatory approval process, is to be expected. Responsibilities: ? Perform finite element analysis (FEA) and computational fluid dynamics (CFD) analysis to support new device design; ? Collaborate with other members of the Computer Aided Engineering (CAE) Team at MED to develop, implement and standardize analysis methods for device design; ? Interact with interdisciplinary teams of scientists and engineers to develop and optimize novel medical devices; ? Research new technologies and integrate new capabilities into the product development team; and ? Interact with experimental teams to confirm device performance and assist in the development of experiments. Job Requirements ? MS or PhD in Biomedical, Mechanical Engineering or a related field and 2+ years industrial or laboratory experience; ? Experience with Abaqus FEA and medical device design is strongly preferred; ? Experience with CFD is advantageous; ? Experience working in multidisciplinary teams is beneficial; ? Exposure to regulatory support is desirable; and ? Ability to communicate well through written and verbal means is required....

Neurotechnology Engineer - CE1-3096

Security Clearance: Secret Required Experience: 1 Year Required Education Level: Bachelor's Degree Concentration: applied math, electrical engineering, computer engineering, physics, biomedical engineering, Support development of advanced brain computer interaction technologies. Essential job functions: Participate in design, implementation, test and refinement of software in MATLAB and/or C/C++ for data acquisition, signal analysis, and machine learning for brain computer interaction technologies. Participate in hardware integration to support Brain Computer Interaction Technology testing and analysis. Support development of technical papers and presentations....

Product Engineer

PDS is seeking a Accounting Support Specialist for an open position in Tarrytown, NY. In your role you will: The Method System Performance Evaluation Engineer has responsibility for: ? Method-System/Software Performance Evaluation studies for in-vitro diagnostics (IVD) instruments. ? Test Definition (TDef) generation, including interface with Global Assay Development, and creation and verification of TDefs. ? Development of wet testing portions of instrument manufacturing quality control systems. Responsibilities ? Overall responsibility ? The Engineer will be a member of the team responsible for test definition testing. Primary responsibilities are to perform testing to ensure assay test definitions meet specifications, feature and quality objectives. ? Skill and ability to collect, organize and analyze data; summarize findings; develop conclusions and recommendations from appropriate data sources. Additional objectives of the position are: o Execute verification and validation testing o Review test data against established pass criteria o Perform routine laboratory, immunoassay and chemistry system maintenance ? Basic knowledge of engineering discipline(s) (e.g., system and software engineering) applied to product related systems throughout the product development life cycle, from concept development to deployment....

Assistant Project Engineer

Primus, a Subsidiary of ASRC Federal Holding Company, is currently seeking an Assistant Project Engineer at the Plum Island Animal Disease Research Center, located on Plum Island, NY. (1.5 nautical miles off North Fork of Long Island & 6 nautical miles off coast of Old Saybrook, CT). Marine transportation furnished. Summary: Serves as assistant to Program Engineer. Provide engineering technical input, oversight and support to all special projects assigned to an operations and maintenance contract at a research facility. Assist in various special projects; plans work for special projects and ensures projects remain on schedule and on budget. Typical projects include new construction; renovations; facility modifications; utility systems installations; upgrades and repairs. Perform estimates and plan projects from design work through completion. Work is performed in support of a research laboratory and ancillary utility plants. Supervise and direct maintenance and trades personnel as applicable to projects. Roles/Responsibilities: Under supervision, develop solutions to facility & equipment problems, prepare cost estimates & subcontract bid packages. Ensure quality performance in the execution of various work projects. Manage work project expenditures & budget. Provide technical input as relates to applications of maintenance and repair strategies. Ensure aspects of bio-safety and integrity in planning and performance of work projects. Monitor operations to ensure that staff members comply with administrative policies and procedures, safety rules, union contracts and government regulations. Evaluate operations and maintenance needs; equipment replacement requirements; cost effectiveness of programs, equipment, and procedures; knowledge and use of autocad a plus. Oversee the review and evaluation of status reports to determine problem areas and plan improvements in the allocation and utilization of personnel, materials, time, and equipment. Review and recommend vendors and new technologies. Ensure adequate and cost-effective supplies and equipment are available to meet operational needs of the facility. Requirements: Bachelor degree in engineering or a technical field with a minimum of 5 years facilities O&M services industry, preferably in a biomedical, nuclear power, hospital/health care or research laboratory environment. Possess knowledge of mechanical & electrical systems to include; HVAC, utilities, WWTP systems & maintenance trade work. Knowledgeable in regulatory compliance for: OSHA, local, state & federal policies & laws, fire & related codes. Proficient in organizing, communicating with management, problem solving, & providing excellent customer service; must possess excellent communication skills, both verbal & written. Must be capable of multi-tasking & supporting numerous assignments. Experience with project management & work management processes required. Ability to obtain and maintain a Gov?t security clearance. ASRC Federal and its Subsidiaries are Equal Opportunity / Affirmative Action employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status...

Product Specialist - Medical Device. Great opportunity for motivated recent grad

Oscor designs, manufactures and sells a variety of highly specialized implantable cardiac pacing leads, venous access systems and diagnostic catheters with sales to over 65 countries internationally. As a leading manufacturer of cardiac medical devices, Oscor offers excellent career opportunities and great benefits within a fast-paced and challenging environment. POSITION SUMMARY: The Product Specialist is a technical specialist responsible for coordinating the business objectives for an assigned cardiac device product line, helping to define and serve immediate customer requirements, identifying/analyzing opportunities for new product development, and promoting existing products through marketing activities to drive product-line growth. To do this successfully, the Product Specialist is responsible for understanding and researching technical data, customer needs and sales requirements, working closely with sales, product development & manufacturing divisions to translate data into opportunity and respond to market feedback. The Product Specialist must have effective communication and technical knowledge to coordinate the product line, working interdepartmentally to develop strong strategies during the life span of the product including strategy for next generation. TYPICAL DUTIES AND RESPONSIBILITIES: Serve as a technical specialist for the assigned product line. Develop strong understanding of specification, customer applications and competitive marketplace Prepare reports and scheduled updates on assigned pre-market and currently marketed products including metrics, strengths, gaps, long term strategies, etc. Work with field sales representatives to identify new customer opportunities and identify product improvements to maintain cutting edge product innovations Identify and analyze opportunities. Monitor industry trends, application advances, competitive products and technology developments Assist in the development of technical reports and engineering feedback. Work with Engineering to review beta testing, drawings and product specification Assist in analyzing product requirements and creating Bill of Materials (BOM) for assigned products Collaborate effectively with other departments within the organization to achieve results and ensure that all expectations are defined and meet, including sales, customer and regulatory requirements Participate in defining long-term strategies, marketing materials, order budgets, targets and other business related processes...

Engineering Specialist

The Senior Scientist/Engineer position, Product Development will be working as part of a multi-disciplinary team and be responsible for the development of new consumables in the areas of microfabrication, microfluidics, cell isolation and analysis during feasibility and development. He/She will also be involved in interfacing between the instrument, software and assays in order to refine system requirements and develop the strategy for Integration, System Verification and Validation. The candidate will be independently responsible for the conception, design, implementation and interpretation of scientific research projects pertaining to the fabrication, process development and testing of microstructure based devices for biological analysis. The candidate will be required to conduct experiments on early consumables and prototype/breadboard fixtures in an effort to refine requirements and identify areas of risk and mitigations for those identified areas. Additionally, the individual may be required to assist in similar activities for other subsystem areas depending on the nature and complexity of the feasibility and integration activities. The successful candidate will develop concepts, strategy, test plans/protocols and reports for feasibility and integration activities to be compliant with regulatory requirements, and J&J procedures. He/she will be providing direction to other team members who will be responsible for executing test designs along with the candidate, and performing the data analysis/evaluation to draw conclusions and write reports associated with the activities. This person will be responsible for effectively interacting with people representing a broad array of technical specialties to achieve success. He/She will be responsible for thinking broadly, unconventionally and being open to new ideas from others. Qualifications A minimum of a Master?s degree (PhD preferred) in Biomedical/Chemical/Mechanical Engineering is required. At least 5 years experience working in a laboratory or medical device/diagnostics industry is required. Hands-on experience in microfabrication (soft lithography, hot embossing, molding), microfluidic testing, surface modification, materials processing is required. Experience in MEMS processing, mold fabrication is desired. Experience in cell isolation, biological analysis techniques is a big plus. Experience working under QSR design control processes for Medical Device is a plus. Experience with disposable design for manufacture and commercialization will be important, including an understanding of material and surface properties of polymers and their properties, manufacturing techniques for high precision disposables, quality control and analytical techniques. Must have a strong knowledge of statistics, especially related to Design of Experiments (DOE) and excellent technical writing skills. The successful candidate should possess excellent analytical and critical thinking skills, strong oral/written communication skills, a passion for science, dedication, focus, quick learning abilities, the ability to multitask, and good experiences with interdepartmental and external collaborations....

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....

BMC Engineer

Overview: Bard Medical?s Climber (BMC) program is designed to develop the next level of technical leaders at Bard. This two year program provides exposure to multiple functions and product lines in the business including Research and Development, Quality Assurance, Manufacturing, Marketing or Regulatory Affairs. The BMC Engineer is expected to learn the business and be a contributing member on assigned projects. The BMC Engineer learns and develops through on the job training, a formal mentoring program, customized training curriculum and group presentations. Summary of Position with General Responsibilities: The BMC Engineer performs various product development functions and associated support tasks in developing knowledge and experience in key areas of the medical devices industry. This includes working to support projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments. ?Four 6 month rotations : ?Rotation 1: R&D or Quality ?Rotation 2: R&D or Quality ?Rotation 3: Manufacturing ?Rotation 4: Marketing or Regulatory Essential Job Functions: ESSENTIAL DUTIES AND RESPONSIBILITIES mayinclude the following. Other duties may be assigned. Research & Development Rotation Perform, organize, plan and document research activities leading to new or improved products with urological and surgical applications. Performs tests and experiments in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Quality Rotation Creates and reviews Test Methods Creates/reviews Protocols, Process and Product Validations, Stability Protocols Creates and reviews documents required for Design History File. Manufacturing Rotation Develops, updates, and implements plant PSM procedures. Maintains and coordinates all process safety related information for the plant. Identifies, determines, and implements engineering technical practices, standards, and process industry practices for all plant processes. Marketing Rotation Analyze sales results and perform appropriate research to understand product segment potential ? understand market segment potential, trends, and needs Monitor competitive activity and develop competitive rebuttals Perform VOC of lines extensions and new products Regulatory Affairs Rotation Provide regulatory support of product project teams (e.g., developing regulatory strategies, timeline development, and reviewing submission related documents) Prepare worldwide submissions, as required. Provide review of product labeling for worldwide regulatory compliance. General Provides support for Project Teams or Franchise Teams as required. Ensures compliance to Department and Division procedures. Represents the Corporation, Division and Department in a professional manner. Travels as required by the above duties and responsibilities....

Sr. Engineer Specialist

The Senior Scientist/Engineer position, Product Development will be working as part of a multi-disciplinary team and be responsible for the development of new consumables in the areas of microfabrication, microfluidics, cell isolation and analysis during feasibility and development. He/She will also be involved in interfacing between the instrument, software and assays in order to refine system requirements and develop the strategy for Integration, System Verification and Validation. The candidate will be independently responsible for the conception, design, implementation and interpretation of scientific research projects pertaining to the fabrication, process development and testing of microstructure based devices for biological analysis. The candidate will be required to conduct experiments on early consumables and prototype/breadboard fixtures in an effort to refine requirements and identify areas of risk and mitigations for those identified areas. Additionally, the individual may be required to assist in similar activities for other subsystem areas depending on the nature and complexity of the feasibility and integration activities. The successful candidate will develop concepts, strategy, test plans/protocols and reports for feasibility and integration activities to be compliant with regulatory requirements, and Client procedures. He/she will be providing direction to other team members who will be responsible for executing test designs along with the candidate, and performing the data analysis/evaluation to draw conclusions and write reports associated with the activities. This person will be responsible for effectively interacting with people representing a broad array of technical specialties to achieve success. He/She will be responsible for thinking broadly, unconventionally and being open to new ideas from others....

Biomechanical Engineer

Biomechanical Engineer : We currently seek an experienced Biomechanical Engineer to support operations in our Houston office. This is an exciting opportunity for anyone seeking to branch out and explore the world of forensic consulting. Essential Job Responsibilities: 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. Reviewing of material (e.g., photographs, witness statements, depositions, police reports, medical and chiropractic records) to provide logical conclusions. You must be able to 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 South Central Region and occasionally outside the South Central 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....

Sr. Manufacturing Engineer

Job is located in Carlsbad, CA. Sr. Manufacturing Engineer We currently seek a high caliber Sr. Manufacturing Engineer for a long-term direct hire basis within our client?s team of experienced professionals. Based in Carlsbad, CA. Job Requirements Lead the design transfer of new products and or the enhancement of existing products as a team member for Operations. Develop the processes for Manufacturing, Quality Control, Regulatory and Planning for the particular project. Create and coordinate the implementation of new or improved manufacturing processes. Assist in various engineering assignments ranging from feasibility studies to introducing processes to Manufacturing. This position is responsible for establishing Lean processes in the manufacturing and material operations. Lead the validation efforts for New Product Development projects transferring into production. (IQ/OQ/PQ) Develop new manufacturing processes and/or serves as a core member of a project team. Improve current processes and products for quality and cost. Provide operations and manufacturing expertise for new projects from concept through production. Interface with production on all activities associated with new process or product implementation and transfers. Evaluate proposed designs and processes for manufacturability and demonstrate value engineering concepts. Establish robust, repeatable and reproducible process parameters. Apply engineering knowledge and experience to application and development of new product designs and/ or processes to exceed customer expectations. Provide continuous development that will improve in house capabilities, yields and efficiency. Develop improvements to tooling and processes for the manufacture of existing products Assist in establishing the specifications and procedures under which new products will be produced Identify and implement cost reduction opportunities Review tools and perishable machine parts drawings for the necessity of revision for tolerances, surface finishes, dimensions, and material selection Investigate and troubleshoot production difficulties and processing issues and implements process improvements (Corrective And Preventive Actions) Maintain regular and consistent attendance at the normal worksite...

Quality Engineer

Quality Engineer About the company: Secant Medical designs and manufactures biomedical textiles and other structures for medical devices. Employing medical fabric engineering technologies, we blend polymeric, metallic and resorbable biomaterials to create custom, high-performance structures that are used in the cardiovascular, general surgery, neurovascular, orthopedic and regenerative medicine fields. We collaborate with clients to develop a device design that incorporates the physical, mechanical, and performance characteristics aligned to the anatomical and physiological requirements of the application. Our focus is on precision, efficiency, quality, and flexibility throughout the product development process. This position includes a compensation package that includes a base salary plus incentive based on company performance. Position Summary: Plans and conducts activities concerned with development, application, validation and maintenance of manufacturing and quality management systems for textile and biomaterial based medical and industrial processes, materials and products by performing the following duties. Responsibilities: Develops and implements methods for sampling, inspection, testing and evaluation of products Develops the full reliability and inspection plan for all new products Performs Risk Management activities Conducts and leads design / process failure mode effects and analysis Develops and implements statistical methods and design experiments to support new product development Knowledge of QSR, ISO, UL, and IEC requirements. Design Control implementation Applies statistical methods and process / design excellence tools to establish test plans as well as evaluate test data and processes. Supports research and development and manufacturing departments to ensure successful transition of products and processes from design to production Initiates process improvement projects to increase efficiency, reduce costs, simplify processes and improve quality Supports process and test method validation activities by developing and executing protocols for new or existing processes Interfaces with customers and vendors to provide technical support for our products and assures quality of incoming materials Develops and implements methods and procedures for disposition of nonconforming material and ensures that effective root cause analysis is conducted; tracks implementation of corrective / preventive actions Develops and initiates standards and methods for inspection, testing and evaluation Provides leadership in the understanding of medical device regulations to other disciplines Manages program to evaluate precision and accuracy of production equipment and testing, measurements and analytical equipment and facilities Assists in directing inspectors engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability Develops and writes internal specifications, work instructions, supplier part specifications, internal test methods...

Imaging Engineer

Job Title: Imaging Engineer Location: Raritan, NJ Duration: 12+ Months with possibility of extension Responsibilities: The candidate will have primary responsibilities to develop algorithms for processing multispectral images and performing object identification and feature extraction from biological samples. Specific responsibilities will include: Develop computer vision and image understanding algorithms that enable automated interpretation and information extraction from images Conduct cutting-edge research that leads to real-world commercial applications and translate innovative ideas and algorithms to prototype software and solutions Develop innovative solutions and implement prototypes, employing an ?experiment and learn" approach to design experiments that assess feasibility In support of these, the individual is expected to: Conceive, plan, and implement solutions to technical problems requiring unconventional approaches, new designs and equipment and/or process development. Serve as the company imaging specialist; keep abreast of new technical developments affecting the organization in the area and image processing and analysis Interact with software developers during implementation of imaging algorithms in the commercial product Practice company safety and quality policies and procedures Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Note: Interested candidate can send resume at or can call on 973-646-9983 ....

Sr. Bio Process Engineer

Sr. Bio Process Engineer Start Date: Upon selection of qualified candidate Special Notes/Instructions: Individuals with a disability that require reasonable accommodation for any position for which you apply, or to complete any part of the application process, or are unable to use the online application system and need an alternative method for applying, contact for assistance. Employment Term: Regular Employment Type: Full Time Hours per Week: 40 Starting Salary Range: Commensurate with experience Salary/Benefit Notes: We offer an excellent opportunity to become a key team member of a well-established, performance focused company offering competitive compensation and benefits program. Required Education: Bachelor's Degree Required Experience: 15 to 20+ years Required Security Clearance: None Related Categories: Engineering - Biomedical, Engineering - Chemical Position Description Sr. Process Engineer The Sr. Bio Process Engineer collects and prepares data/information and performs detailed engineering calculations. The Sr. Bio Process Engineer performs engineering design and analysis on complex or unique problems and coaches/mentors less experienced engineers, designers, and drafters. The Sr. Bio Process Engineer demonstrates technical/professional growth annually by maintaining active membership in professional organizations and participating in technical seminars/courses. Responsibilities include the conceptual, basic process design of unit operations and preparation of process engineering deliverables such as process flow diagrams, heat and material balances, P&ID's, specifications for equipment and instrumentation systems. The Sr Bio Process Engineer can serve and experience a diverse set of industries that include Life Science (Agribusiness, Pharmaceutical, Food and Biotech), Process Chemical and Refining. Senior Bioprocess Engineer to serve as lead engineer on bioprocess and pharmaceutical projects reporting to the Process Department Discipline Manager in the execution of projects and participating in the business development effort providing support to the Business Development staff including presentations and sales calls. Essential Functions: Must be capable of leading process engineering and multi-discipline teams through all design phases of a capital project. Collects and prepares data/information, performs detailed engineering calculations, and writes formal engineering/technical reports. Develops technical equipment specifications & data sheets, performs technical evaluation of bids, and recommends best value design which meets client requirements for operability, reliability, maintainability and safety. Leadership in field work by checking installations and problem solving activities. Performs calculation checking and equipment vendor drawing reviews. Serves as Project Lead for more complex projects by estimating work hours, developing scope of work, making staffing recommendations, and checking drawings....

Electronics Technician

Fornearly 20 years Soma Technology, Inc. ( www.somatechnology.com ), headquartered inBloomfield, CT, has specialized in outfitting entire healthcare facilities withhigh-quality new and refurbished medical equipment. As a market leader, ourdedication to the advancement of this industry and utmost customer satisfactionhas led to our success. We have full timeopenings for electronic technicians to work in our Bloomfield office to inspect, calibrate, and refurbishbiomedical equipment to meet OEM specifications Dutiesto include but not limited to: Inspecting equipment to accurately identify device parameters that do not meet the OEM documented specifications Proficiently use all test equipment to evaluate assigned devices Reviews and analyzes equipment and devices to see if it meets OEM specifications Identifies corrective action necessary to repair equipment Answers technical questions from customers and internal staff Documents test results and equipment history Researches technical issues using all available data Trouble shoots and identifies correct part necessary to repair equipment and to correct customer problem Certifies equipment has been refurbished to original OEM specifications Consults with customers for the purpose of selling parts, troubleshooting, determining if a service call is necessary and defining the equipment?s capacities? Sets final inspection of equipment before shipping Comply with all applicable standards, policies, and procedures, including safety procedures and the maintenance of a clean work area Travels for onsite evaluations to determine repairs or to oversee installations. ...

Process Engineer

RCM technologies 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 Client network Strong communication and technical writing skills are required....

Mechanical Engineer / Manufacturing Engineer

CONFIDENTIAL - 3rd PARTY RECRUITER My client is looking for a GURU Product Development Engineer and Manufacturing Engineer *Background in ME/CAD/ENG Tech, SolidWorks, ProE, Exp. Designing Mechanical Parts, Prototype Assembly, Small Components / Tolerances Design, Medical Devices+ 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 require a minimum 4 years experience in design of intricate, complex component devices. The candidate will be need hands on? ability and a MASTERY in SolidWorks or ProE as it relates to product designs. The company will consider candidates from any industry but prefers a top tier company and solid work history. (i.e. Boeing 5 years or Toyota 6 years). They are looking for OT 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 Other Highly Desired Applicants: Senior Product Development Engineers with Medical Device Experience Manufacturing Engineers & Senior Manufacturing Engineers Process Engineers & Senior Process Engineers Any Manufacturing, Mechanical and Biomedical engineering candidates with desired skills *Candidates must be out of a TOP Engineering school with near perfect marks - Advanced Degree Preferred Preferred Skills: CAD: SolidWorks, PROE FEA: ANSYS, GD&T Manufacturing: SEMA, LEAN, SPC, Process Flow Strategies (Kanban, Just in Time, Cell Manufacturing, Demand Flow), Blueprints and Specifications, Designing Equipment, Designing Tooling and Fixtures, High Volume Automations - High Speed Assembly, Products to GMP Production, Designing Pilot Scale and High Speed Manufacturing Equipment in State-of-the-Art clean rooms Quality: ISO Standards, Knowledge of FDA Regulations, cGMP for Medical Devices, R&R Highlighted from successful hires: ? ?Streamlined an innovative manufacturing overhaul through a new rotational design cutting manufacturing time by 30%? ? ?Cut cost of manufacturing by 22% for small tolerance spinal implant device? ? ? Manufacturing process of cardiac stent from 6 to 4 steps while increasing quality benchmarks? ? ?Part of the design team responsible for several profitable patents and the leading product driving company revenues? ? ?Lead designer that won the prestigious MDEA (Med Design Excellence Award) for reverse engineering competing drug delivery product and bringing to market at a cheaper cost? Thank You, Robert Bennett CEO, Director of Client Acquisitions Asset Personnel Solutions Submit Resumes Attention: Robert Bennett Resumes@Asset-personnel.com...

Assistant Engineer/Associate Engineer (#2014-0903)

ACEABiosciences, Inc. is looking for an Assistant/Associate Engineer with thefollowing responsibilities, under limited supervision from research scientistsand engineers, building/testing/troubleshooting/modifying prototype systems, performingdesign verification and validation on functional instruments, projectlogistics, and participating in product engineering development and sustainingengineering after product launch. Workwill center around development of a bioanalytical instrument system involving electronics, mechanicalhardware, fluidics subsystems, optical engine and detection, and software/firmware. DUTIES ANDRESPONSIBILITIES : Participate in various engineering design/development activities Read engineering drawings (e.g., electronic schematics, blueprints, mechanical drawings) and engineering instructions for assembling various systems/sub-systems Construct various engineering prototype models (e.g. fluidics, optics) to meet engineering requirements Design experiments for sub-system (electronics/fluidics/optics/mechanics) testing and verification Design and perform experiments for system-level validation and long-term system reliability test on functional instruments Participate in trouble shooting and problem solving during various stages of product development Participate in product improvement and sustaining engineering development Record and analyze experimental data. Write test procedures and test reports Participate in document preparation for project meeting and review Project logistics (component selection, ordering, vendor/supplier inquiry) Perform non-routine assignments of substantial variety and complexity Conduct other engineering development activities or company/project required duties...

Manufacturing Process Engineer/Test Method Validation Engineer

Hi , I am Gunjan Singh, Technical Recruiter with American Cyber Systems. ACS is a multinational organization with more than $400 million in sales, more than 6,500 employees and locations all over the globe. Our focus has allowed us to serve clients in virtually every industry, from startups to Fortune 100 enterprises. I have the following contract position available with our direct client. Interested candidates, kindly revert with their updated resume and rate expectations, with the same subject line. Candidate Full Name ? Work Authorization status (H1B/OPT/Citizen/ Green Card/EAD/TN)? Current location ? Availability ? Best time and number to call ?...

Senior Engineer I, Software

This position is responsible for the implementation of software systems or applications for software enhancements and new products according to defined specifications and existing processes in a team environment to meet business and quality objectives. Execute according to software standards for life cycle, documentation, development methods, testing, and maintenance. 1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 2. Execute all aspects of software development according to standards, including specification, design, and implementation of Terumo software development procedures. 3. Assist with establishing quantitative measurements and techniques for measuring software quality. 4. Provide technical leadership on software development tasks. 5. Generate, and evaluate software documents and code. 6. Evaluate and recommend tools, techniques, and technologies used in software development. 7. Prototype software for demonstration/feasibility purposes. 8. Perform hardware/software integration and testing. 9. Contribute to the planning, implementation and completion of projects to develop, install, and qualify new processes for manufacturing new products or improving existing products / processes. 10. Recommend through research cost reduction projects and opportunities for productivity and quality improvements. 11. Provide support for testing software systems or applications for software enhancements and new products. 12. Define software requirements and assist in defining verification requirements. 13. Gather, track, and analyze data for meetings, business plan, etc. (yields/output/efficiencies). 14. Plan work schedules, expenditures, attend meetings, and prepare reports as required. 15. Perform other duties as assigned. (rev. 5/29/12) At Terumo Cardiovascular Group, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. Each year, millions of patients around the world benefit from the use of our products. Our corporate headquarters is located in Ann Arbor, Michigan along with one of our manufacturing sites. We also have manufacturing sites in Elkton, Maryland and Ashland, Massachusetts. Our parent company, Terumo Corporation, is a global medical device manufacturer focused on cardiac and vascular specialties, hospital and home health care products....

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...

Quality Engineer II - Supplier Quality

The Supplier Quality Engineer will be responsible for preventing discrepancies through the proper selection, appraisal, monitoring, improvement, education and correction of our most critical partnerships, our suppliers. Responsibilities: - Preventing supplier related discrepancies - Mitigating supplier risks- Monitoring supplier's performance - Correcting supplier deficiencies - Partnering with high quality suppliers. Supplier Quality works closely with Product Teams, Suppliers, Research and Development and Receiving Inspection to ensure: ? Strategic Supplier Selection? Supplier Certification? Supplier Performance Monitoring (supplier report cards)? Supplier Improvement / Enhancements (Capability studies, Gage R&R, Supplier Action Requests)? New Product Support (Process validation, Inspection Planning, Special Inspection Support)? Supplier Risk Mitigation and Controls (Functional Gaging, Supplier Surveys New Supplier Qualification (Supplier Audits)....

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 Engineer

Teleflex has a great opening for an Engineer/Technical - Project Team SME in RTP, NC. The purpose of this position is to lead, coordinate and provide, within a dedicated project driven strategy, all technical phases of design change, whether in product development or product reengineering, including design and development planning, develop product performance specification and requirements definition, product development process, evaluation and manufacturing aspects using Teleflex/Arrow?s design control and Product-to-Market Processes. Ideal Candidate for this position is an optimistic self-starter that is results driven, who excels in a dedicated or project focused, transparent, and team based environment. PRINCIPAL RESPONSIBILITIES: ?Engineering lead for all aspects of re-engineering existing products including the design, prototyping, testing (verification and validation), risk management and documentation. Lead the redesign of existing components to improve quality, utilize automated product techniques, optimize process capabilities, and produce better products in a more cost-effective manner. ?Interface with clinicians, marketing, and process development to understand customer preferences/requirements and establish design criteria for new products and product improvements. ?Identify and create new design and/or process concepts. Design and validate products and components using engineering principles and adhere to the design control process as appropriate. ?Lead, conduct and/or participate in design and technical phase reviews. ?Interface with vendors to obtain quotations, purchase components, and debug problems with production parts. ?Interface with Sourcing to develop vendor supply agreements for components and/or new products. ?Interface with process development engineers, manufacturing and lab technicians to design and develop new fixtures, tooling, and machinery. Assist in the development and qualifications of required manufacturing processes. ?Assist process development and manufacturing personnel with the transfer of development projects and design changes into production. ?Support regulatory submissions and clinical trials as required. ?Update and review project progress on an as required basis by supervisor. ?Meet all project objectives, milestones, and target dates. ?Assist in the tracking and communication of project developments from prototype design through testing and into production. Formulate decisions to facilitate project advancement. ?Ensure projects are developed and documented compliant to the Arrow/Teleflex Quality System. ?Adhere to and ensure the compliance of Teleflex Code of Ethics, all Company policies, rules, procedures and housekeeping standards....

Research Sr. Engineer I

Job Description: Provides technical support toward the accomplishment of research and product development team objectives. Incumbent will be responsible for several research and testing projects. Principal Duties and Responsibilities % 25 ? Responsible to implement assigned research projects in a timely and efficient manner and to report their results to the responsible research manager. 25 ? Assists in the development of individual research and testing project plans, and in the scheduling of test programs and the management of workload in the assigned laboratory to help assure timely and satisfactory completion of assigned projects 10 ? Monitors scientific and medical literature for advancement relevant to the assigned research and testing objectives. 10 ? Consults with and provides technical evaluations for other departments (Manufacturing, Legal, etc.). Is responsible for the calibration, safety, maintenance, and efficient utilization of testing equipment in the assigned laboratory. 5 ? May provide guidance in the work of technicians 25 ? Will work with test requestors to develop test programs, formulate test protocols, and choose appropriate test equipment. This will include supervision of fabrication, or selection of new equipment as required. 100 Total Percent (not to exceed 100%) *Individual percents should be greater than or equal to 5%. This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA. Expected Areas of Competence (i.e. KSAs) ? Must possess an advanced knowledge of material science, engineering, manufacturing processes, and research technologies applicable to assigned areas of responsibility. ? Knowledge of national and international testing standards related to work in their assigned laboratory. ? Possess good oral and written communication skills. Education/ Experience Requirements ? BS in Mechanical/Biomechanical/Biomedical engineering required; MS or PhD strongly preferred ? 3 years of relevant research/testing experience (fatigue and static testing of metals)and have strong technical skills in mechanics/strength of materials, statics and dynamics. Travel Requirements ? Up to 15% Skills: SkillsSkills Skills:Category Name Required Experience No items to display. Additional Skills:...

Mid-Level Java/Spring/RESTful Developer Bethesda, MD up to $110k

Mid-Level Java/Spring/RESTful Developer ? Bethesda, MD up to $110k Job Duties ? Work closely with research staff to deliver the next generation of literature search system ? Implement content generation and delivery of components for biomedical researches, clinicians and the general public ? Design a development of a new architecture based on RESTful services ? Will use skills such as Java development, Rest Services and XML Required Skills ? Specific background, experience, skill set and focus on backend systems architecture, building distributed systems ? 5+ years of professional experience using Java technologies ? Experience with RESTful APIs ? Experience with MongoDB/Solr/Cassandra is a plus ? Multi-threaded server side development ? Experience with Java Spring Framework ? Experience in XML/XSLT ? BS in Computer Science or related field with 3-5 years practical experience designing and developing modern, object-oriented, large scale systems Desired Skills ? Comfortable in a Unix/Linux environment ? Familiarity/experience with database design using SQL, NoSQL, and/or Mongo DB ? Working knowledge of Perl scripting ? Familiarity with Web Services (REST, SOAP) For immediate consideration please send resumes (Email Address Withheld by Request)...

Business Analyst - LIMS

Job Summary for the Business Analyst: Our client, a growing medical research organization, is looking for experienced business analysts who are looking for an opportunity to work with an innovative team. The Business Analyst will work with a close-knit team that is implementing an enterprise Laboratory Information Management System in an organization working to find solutions to empower the global biomedical community in their pursuit of advancing human health. The Business Analyst will have experience in Laboratory Information Management Systems to contribute to a multi-year implementation of an enterprise LIMS system across several dozen laboratories at multiple sites in the organization. The successful candidate will be part of the LIMS implementation team and will work closely with laboratory personnel to define and document configuration of user interfaces, map process and workflow, provide data management, and define systems integrations to meet the rapidly growing and highly integrated needs of laboratory service groups. Responsibilities of the Business Analyst: Lead functional and technical requirements development Assess and validate solution options against requirements Participate in design, configuration and customization of solutions Author "As Is and "To Be workflows, requirements, use cases, and other relevant documentation...

Sr Quality Systems Engineer

PURPOSE AND SCOPE: Supports FMCNA?s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements. Provides quality engineering expertise to the analysis and investigation or product quality issues with the intent of reducing complaint levels and improving customer satisfaction. Provides quality engineering support to QS/RA functions and to all RTG manufacturing locations as required, based on both in-process manufacturing and post-market quality analyses. DUTIES / ACTIVITIES: CUSTOMER SERVICE: Responsible for driving the FMS culture through values and customer service standards. Accountable for outstanding customer service to all external and internal customers. Develops and maintains effective relationships through effective and timely communication. Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner. PRINCIPAL RESPONSIBILITIES AND DUTIES Responsible for coordinating an on-going Corporate Quality Programs (examples are Risk Management, CAPA, Supplier Management, Complaints or Monitoring of Quality Data) that may be assigned to one or more Quality Systems Engineers. Ensure program goals are met by communicating and following-up on schedules with program participants. Responsible for preparing regular progress reports on their programs. Institutes corporate policies and procedures; ensures all parties receive appropriate training. Publishes regular updates regarding the integration status reports. Participates as a member of the facilities Audit Team in performing internal and external audits as required. Assist in providing in-house training (e.g., risk management, statistical sampling, CAPA) in conjunction with corporate training department to plant staff, as assigned. As required, assumes responsibility for timely completion of Adverse Trend Investigation Reports, including obtaining agreement/commitment to Corrective Preventive Action recommendation. Monitors and follows-up regularly regarding the implementation and effectiveness of Corrective & Preventive Actions recommended in ATIRS. Establishes personal quality improvement goals. Has the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible production, stocking, or shipping of discrepant assemblies or product arises. Other duties as assigned....

Senior / Principal Clean Utilities Engineer

Senior / Principal Clean Utilities Engineer 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/Principal Clean Utilities Engineer with experience developing and implementing cost-effective equipment, facility and utility engineering solutions in a fast-paced cGMP biopharmaceutical environment....

Project Design Engineer

. Primary focus of the Project Engineer, Medical interconnect position is to develop new products targeted at medical industry (ie. I/O cables and other medical peripherals that can be sold into different modalities of therapeutic, diagnostic and invasive in the medical marketplace). Responsibility includes product development from concept through commercialization in shortest possible time, cost effective within budget which meet or exceed performance to generate revenue and growth for the business unit. Projects are likely to center on developing next-generation products and solutions globally. Manager to review designs, monitor project and provide assistance when barriers are encountered. UTIES & RESPONSIBILITIES: 1.Leads new medical product design efforts using the Product Development Process from product concept through production. 2.Provides technical support to customers, suppliers and inside personnel. 3.Performs design verification activities to ensure that design meets the specifications of the customer and UL requirements. Checks manufacturing and sales drawings for completeness and accuracy. 4.Uses risk reduction tools to perform FEA, model simulation etc. knowledge of material costs and costing processes to determine the impact on various designs. 6.Responsible for loading all products released BOM?s (Bill of Material) and Material Master data sheets through SAP/software. DUCATION: REQUIRED: Bachelor?s degree in Mechanical Engineering or Physics PREFERRED: Biomedical engineering degree. WORK EXPERIENCE: REQUIRED: 5 years design experience of connectivity systems, devices, connectors, or components AND Design of medical I/O cables and other peripherals for medical device market SKILLS & ABILITIES: ? Proficient in solid modeling experience to generate 3D models & 2-D drawings. ? Knowledge of medical based materials used in design of cables and devices - Including impact of ETO and gama ray exposure ? Experience with testing medical grade products - standards and methods ? Analytical ability to apply logical reasoning, test assumptions, observe results and make corrections ? Strong verbal and written communication skills that demonstrate the ability to express complex technical concepts clearly and concisely ? Good interpersonal skills to work effectively with others and in a team. ? Travel will be required as necessary...

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....

Field Service Engineer (D14-074)

Provide customer site repair and maintenance on CDG group instruments primarily in the Richmond, Virginia area. Other assignments will require extensive travel. Required Skills: Technical skills must include electronic, electromechanical and computer maintenance experience. Must have good communication and customer relation skills. Experience in a clinical lab environment a plus. Required Experience: 3-5 years clinical instrumentation repair, military electronics, Bio-Medical, or competitor experience....

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....

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...

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...

Biodefense Laboratory Validation Engineer Scientist

Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at USAMRIID . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team. We are currently seeking a Biodefense Laboratory Validation Engineer Scientist for the Frederick, Maryland area. RESPONSIBILITIES: The candidate will perform the following functions: 1. Develop, execute, and report all validation and qualification activities for aerobiological laboratory instrumentation to meet GLP requirements, including but not limited to developing user requirements (URS), design qualification (DQ), installation qualification (IQ), operation qualification (OQ), performance qualification (PQ), maintenance qualification (MQ), and component qualification (CQ). Identify the qualification/ validation requirements necessary to maintain the system?s validated status 2. Assist with SOP writing and revision to meet GLP requirements 3. Assists the Department Chief, Aerosol Technology and Training, on technology improvement initiatives MINIMUM QUALIFICATIONS: 1. B.S. in Chemical or Mechanical Engineering or similar scientific discipline, MS is preferred 2. 3yrs of laboratory experience with pharmaceutical equipment qualification/validation 3. Experience with aerosols and/or aerobiological equipment is a plus 4. Must be able to work independently following a brief period of specific technical training. Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM?s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks. ClinicalRM is an Affirmative Action-Equal Opportunity Employer www.clinicalrm.com ?NorthCoast 99? Best Places to Work recipient...

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...

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