Biomedical Engineering Career Careers in the United States

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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 Lead

Biomedical Technician Contract/Contract to Hire/Direct Hire Los Angeles, CA *Subject to background and drug screen Pay range: Hourly $25 - $35/h r The Biomedical Technology Specialist III provides high level of expertise in the maintenance and repair complex biomedical systems and devices located within the company. Provide technical leadership and guidance to other Biomedical technicians on project implementations, networking and physiological patient data integration and act as a liaison to IS/PMO for biomedical project matters. Maintains accurate documentation to meet JCAHO and DHS requirements as they pertain to Medical Equipment Management Plan. Under limited direction, responsible for providing physiological monitoring data backup, recovery and security procedures. Has responsibility for the physical management of the Biomedical Engineering data, including regulatory documentation and report production, for various committees, agencies and management presentations. Titles & Number of Employees Supervised: Functional supervision of several Biomedical Technichians II, Biomedical Technichians I and Biomedical Assistant. A great degree of individual responsibility on the part of the technician is required. Approximately only one third of the workload is performed in the workshop, while two thirds is performed in patient care areas. Equipment/Machines Used: Defibrillator analyzer, electro surgical analyzer, electrical safety analyzer, Patient simulator, Oscilloscope, digital/analog multi meter, frequency counter, power supplies, function generator, various hand tools, ultrasound output analyzer, TENS output analyzer, gas flow analyzer, anesthesia gas analyzer, laser power meter, Anesthesia machine, cell savers, ventilator, blood pumps and other electronic diagnostic equipment. To provide the highest quality technical service and to reduce the downtime of essential surgical systems, while completing all scheduled work as required. Interface with medical and nursing personnel, and keeping a professional approach at all times....

Biomedical Technician

Biomedical Technician FT Days: 7:30 am to 4 pm The Biomedical Technician is responsible for ensuring the maintenance of all Biomedical equipment throughout the facility as well as implementing processes for the effective and efficient delivery of services for all aspects of medical equipment at the facility. Biomedical Technician...

Director, Biomedical Engineering

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

BIOMEDICAL REPAIR TECHNICIAN II

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

Biomedical Engineering Technician Associate (BMET)

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

Biomedical Electronics Tech TEMP

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

Service Manager / Equipment Technician

Job Summary : The Biomed Supervisor is chiefly responsible for the orderly operation of the site and a resource for all technicians. He / She will function at the BMET II or higher-level and will be capable of troubleshooting, repairing and performing preventative maintenance on a wide variety of medical devices including Beds, Mattresses, Ventilators, Wound Pumps, etc? Primary Responsibilities: Will function as a technician as well as a supervisor Will identify training needs for biomedical personnel. Will assure the service area is clean and orderly, providing a safe environment for service personnel. Will assure accurate database entry and reports. Expected to meet production goals set for department to keep rental equipment patient ready. Be able to document and maintain appropriate paperwork for site including employee write ups and routing forms. Manage and perform on-call responsibilities. Organize after-hours on-call rotation for self and staff. Expected to perform all duties under biomedical technician?s responsibilities, including repair, pm, cleaning and delivery driver responsibilities. Responsible for Inventory control and repair part ordering. Will be expected to work Overtime with short notice. Responsible for sale order processing and fulfillment. Responsible for all Distribution Dispatching when the Operations Manager is not available. Expected to provide technical support and troubleshooting for customers as needed. Must assist the ongoing training of service, distribution, sales and customer service personnel. Quality Management System: Responsible for maintaining the effectiveness of the QMS as appointed management representative for branch biomedical employees. Ensures that all QMS and safety procedures are followed. Ensures all required records are completed in an accurate and timely manner and available for audit purposes....

Senior Mechanical Engineer / Biomedical Engineer

Senior Mechanical Engineer / Biomedical Engineer The engineer will be expected to evaluate existing products and provide design changes that improve manufacturability, quality, reliability, and reduce cost. The engineer will need to work effectively with our client Neuromodulation Manufacturing, Supply Management, Quality, Reliability, and Regulatory functions to qualify and implement design changes. Responsibilities : Perform detailed design analysis on critical design elements Provide design continuation engineering support for Neuromodulation Implantable Neuro System and implantable drug pump devices, used for movement disorder, gastro uro and pain therapies. Projects require the ability to support design changes that are mechanical in nature. The key at being successful in this job is the ability to multi-task, work effectively cross functionally, drive projects to closure within specified timelines and be flexible on project assignments. Participate, support or potentially lead corrective action teams to resolve quality issues (CAPA process. Required Skills: Requirements for this job are a BS in Mechanical Engineering (BSME) with 3+ years relevant engineering experience in design, development, manufacturing or quality. Experience in the medical industry strongly desired. Understanding of regulatory requirements and processes strongly desired (FDA preferred). Proven ability to work independently with minimal oversight within product development process and complete tasks on time. Knowledge and experience using DFSS/Six Sigma, CAD systems (Pro/E, SolidWorks) and FEA preferred. Skills and competencies include: Good written and oral communication skills Ability to effectively lead projects or project elements in a cross functional team environment, strong presentation skills, strong technical writings skills Thrives on variety and flexible project assignments Understand manufacturing processes and quality Computer competency Problem solving skills Time managements skills Strong team work and multi-tasking skills. For more information please contact Stefanie Welch at 952-835-4446 ext 264 or email . Since 1995, iTech Solutions Inc., has been providing Consulting and Direct Hire Services to the Insurance, Financial, Communications, Manufacturing and Government sectors with local offices in Connecticut, Minnesota, Colorado, Massachusetts, Tennessee, and New Jersey / Pennsylvania area. Our recruiting strategy is simple, if you want to find qualified IT professionals then use IT professionals to find them. So at iTech Solutions, our personnel are all career IT professionals with a wide range of IT experience. We can honestly say our staff understands the technologies, the complexities of finding and selecting the appropriate personnel and the pressures of running successful IT projects. (Other Job Titles: Senior Mechanical Engineer, Sr. Mechanical Engineer, Mechanical Engineer, Engineer, Engineering, Biomedical Engineer, Biomedical Engineering, Biomedical)...

Biomedical Engerineering Technician

Biomedical Engerineering Technician309581WashingtonAdventistHospitalFull-TimeRegular Return to Previous Page ResponsibilitiesResponds to service calls to evaluate, diagnose and perform repair and planned maintenance (PM) on biomedical electronic equipment, verifying proper condition and operation. Also provides training to BioMed Technicians and monitors biomedical equipment vendors performing on-site service.Qualifications* A.S. in Electronics, Mechanical Principles or equivalent formal technical training. * Proficiency to independently perform repairs and planned maintenance on a variety of clinical equipment. * 2 years experience as Biomedical Technician, hospital experience preferred. * Effective technical communications skills. * Ability to work independently and also in a collaborative environment. * Strong customer service skills. * Proficient in PC skills in a MS Windows environment. (e-mail, workorder processing, procurement, etc.)Work ScheduleFull Time day shift with on-call service one week each month.Equal Employment OpportunityAdventist HealthCare is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, marital status, disability or any other basis prohibited by law. Return to Previous Page...

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....

Quality Engineer

Quality Engineering About Our Company: With more than25,000 employees globally, ZEISS is one of the leaders in the optical andoptoelectronic industry. As part of the Medical Technology business group youwill work on simplifying clinical and office workflows through innovativesolutions. Products from ZEISS help doctors to diagnose and treat moreefficiently and reliably, and therefore enhance their patients' quality oflife. Carl ZeissMeditec AG, recently acquired, AAREN Scientific, a US-based manufacturer ofintraocular optical lenses (IOLs) and ophthalmic surgical products for cataractsurgery. AAREN Scientific is located in Ontario, California and seeks experienced, highly motivatedindividuals to support the growth and demands within various departments andfunctions. Within our QM/QC department we need; QualityEngineering Job Summary: This individual will p rovideQuality support for Validations, IQ/OQ and PQs creation and Quality processdevelopment and documentation necessary to integrate and maintain products intothe production systems. Plans and coordinates activities to support new productintroductions and process improvements by performing the following duties. ESSENTIAL DUTIES ANDRESPONSIBILITIES : Other duties may be assigned. Document implementation of QM/QC group (SOP?s; ETE?s). Reviews records; Writes procedures for QM/QC group. Support QM/QC document control function Responsible for QM/QC validations, IQ/OQ/PQs, testing and other assigned QM/QC functions Responsible for regulatory agency audit support, QSR maintenance and improvements and creating improving QM/QC documentation Create new documents in-QM/QC implementation Development/optimization of QM/QC processes to improve product quality Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes. Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence. Establishes statistical reliability by using mean time before failure, weibull 3-parameter distribution, reliability modeling, and reliability demonstration tests. Develops experiments by applying full and fractional factorial techniques. Develops sampling plans by applying attribute, variable, and sequential sampling methods. Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests. Prepares reports by collecting, analyzing, and summarizing data; making recommendations. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies; maintaining ASQ American Society of Quality Control certified quality engineer qualification. Contributes to team effort by accomplishing related results as needed. Quality Engineering...

Engineer- Medical Device

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

Product Manager - Materials Science

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

Field Service Engineer

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

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 MEM

Summary: Perform service work in accordance with established policies and procedures of the HSS Biomedical Instrumentation Department. Works with a high degree of autonomy and may supervise others. Qualifications:...

Data Engineer

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

Director, Facilities Management & Engineering Services

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

140731-1 Project Manager

Point Innovation is an International Design Firm with a creative and innovative Design and Engineering Staff. We are a collaborative design company that produces aviation and product development solutions that are innovative and to the Point. We are looking for a Project Manager to join our team. A. Duties and Responsibilities: Responsible for managing all activities required to define, design, develop and deliver new medical device products. Knowledge of the medical device industry and technology preferred; coupled with broad cross-functional knowledge and comprehensive business management skills. This position provides leadership to cross-functional product development teams, which may include members from the following disciplines: product engineering, quality/regulatory, manufacturing operations, product management, and marketing communications. The Project Manager is accountable for overall project execution and m anages all aspects of the new product development (NPD) project teams per project definition within the Clients Product Development Process (PDP). B. PRINCIPLE JOB DUTIES & RESPONSIBILITIES: Identify and obtain the approval for funding required for an NPD project. Leads and manages a cross-functional team established for the purposes of developing medical device products. Monitors progress toward pre-established objectives, assesses risk and implements strategies to ensure successful delivery of the product(s). Guide and resolve issues that arise through the NPD process. Secures and deploys resources to support the project plan. Maintains effective communication with team members, functional leadership and senior management, in all activities required to design, develop and deliver the product successfully. Communicates status of projects to all affected internal personnel, and promotes project benefits within organization. Reviews product design for compliance with engineering principles, company standards, and customer contract requirements. Directs integration of technical activities and products. Ensures effective transition to relevant manufacturing, distribution, and commercial entities. Directly manages core team members, although members may formally report to functional department managers. Assist with questions and/or concerns and provide technical support regarding product manufacturability, ISO, FDA, IEC and other applicable standards/regulations. Responsible for all project deliverables, reviews/updates, and communications to senior management in accordance with Clients product development polices and processes. Responsible for accurate documentation and ensures that all work is in compliance to Clients policies, procedures, and FDA requirements. Provides input for team member performance reviews. C. EDUCATION AND/OR EXPERIENCE REQUIRED: BS Degree in a technical discipline (biomedical, mechanical, materials, electrical). Engineering degree preferred. MBA a plus. 5+ years engineering experience, 2 years experience in project management, preferably in the medical industry. At least 3 years experience in product development environment Experienced in the principles and practice of new product development. Knowledge of US FDA QSRs, DFSS, and DOE methodologies would be a plus. Understanding of customer needs analysis methodologies such as voice of customer (VOC) and quality functional deployment (QFD) Must have good interpersonal skills to collaborate internally and with customers. Experience in meeting customer requirements through the development and commercialization of products. Able to effectively communicate and interact with senior management, customers, manufacturing, and technical disciplines for collaboration and to make progress on projects. Must have proficient computer skills with all Microsoft business software programs (Word, Excel, PowerPoint, Outlook, etc). Expertise in the use of Microsoft Project. Competent at building business models, strategic and financial justification of initiatives. Strong analytical skills. PMI/PMP Certification a plus. Demonstrated experience leading technical teams with successful implementation of new products to the market place. Please forward your resume to and insert reference code: 140731-1 in the subject line....

Senior Engineer, New Product Development

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

UI Design- iOS apps

Start Date : 8/4/2014 End Date : 2/4/2015 CONTRACT ROLE Job Duties : Participates in Design and Code Reviews,Specifies, Designs, and Debugs, and Verifies Medical Applications Software,Participates in Software Requirements Specifications inspections ,Researches Automated Testing Tools and Techniques Details:- Design and develop Apple iOS apps in conjunction with low power embedded sensor interface electronics, next generation display devices, and software tools for supporting development and test. Basic Qualifications:?BSEE, BSCS, or BS Biomedical Engineering ?Minimum 5 years of software design and implementation ?***Minimum 2 years experience in developing iOS apps.*** ?***Experience in UI design*** ?Overall software system architecture design experience. ?Good oral and written communication skills....

Medical Device Design Engineer / R&D Engineer

Engineer Today, Manager Tomorrow 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 rapidly growing 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 - 1-10 years of 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...

Mechanical Engineering Laboratory Technician

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

Laboratory Technician

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

Process Engineer

A Process Engineer position located in Mountain View, CA is currently available courtesy of Adecco Engineering and Technical. To be considered for this position you must know to execute microfabrication processes with high level of precision and optimize process recipe. The successful candidate will be responsible for executing microfabrication processes used to create prototypes for a wide variety of applications. Experience in hands-on wafer processing is required. Experience with microfabrication on polymers, specifically for biomedical devices, is highly recommended. Responsibilities Execute microfabrication processes with high level of precision Optimize process recipes Research new techniques to improve current microfabrication process Required Skills: Hands-on experience with photolithography, wet/dry etching, and electroplating on polymers Strong attention to detail Excellent documentation skills Ability to work independently Strong organization skills Preferred Skills; Performed microfabrication on polymers for biomedical devices Knowledge of encapsulating devices for moisture protection Experience with handling thin, flexible substrates Demonstration of process management Qualifications: BS in electrical engineering, materials science, mechanical engineer, chemical engineering, biomedical engineering, or related field with at least two years of experience or MS/PhD in one of these fields. If you are interested in this Process Engineer job in Mountain View,CA then please click APPLY NOW. or for other opportunities available at Adecco Engineering and Technical go to www.adeccousa.com. If you have questions about the position please contact Anu at 408-962-4984 or Equal Opportunity Employer Minorities/Women/Veterans/Disabled...

Area Vice President

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

Sr. Mechanical Engineer

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

Electronic Hardware/Engineer

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

Engineering Sales Support Program Project Manager

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

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...

Mechanical Engineer - TSB

The NIH is the premier biomedical research center for the world. Its 27 Institutes and Centers employ approximately 18,000 employees doing a vast array of jobs, all supporting efforts for a healthy nation. For information on the NIH mission, goals, and Institutes and Centers, visit http://www.nih.gov/about Job Description If you have expert knowledge of advanced mechanical engineering principles, practices and procedures relative to the design and construction of biomedical laboratories, animal facilities and healthcare facilities AND you want to play a significant role in a dynamic organization, then consider joining the NIH Office of Research Facilities (ORF)! For more information, visit http://orf.od.nih.gov . Please use https://www.usajobs.gov/GetJob/ViewDetails/377087300 to apply. KEY REQUIREMENTS ? Professional Engineering licensing required. ? Position is subject to a background investigation. DUTIES: Working as a Mechanical Engineer (Technical Support Branch) in ORF, you will: Serves as a consultant to project officers and contractors; performs ad-hoc reviews of contract documents, design and construction contract submissions, including shop drawings, as-builts, control submissions, testing, commissioning, and equipment maintenance and operations. Provides expert advice to other segments of NIH, other agencies, and to contract architect, engineers on mechanical engineering systems, particularly for those of major size and complexity. Oversees major mechanical engineering programs for which DTR is responsible. Responsible for the development and implementation of new approaches to mechanical engineering systems for biocontainment research, animal and healthcare facilities using performance specifications. Provides technical direction to regional offices and to contract architects and engineers where complex problems have arisen in applying new systems building techniques. Prepares or reviews feasibility studies, special reports and investigations on problems related building mechanical systems, their related user needs and testing requirements. Participates in the Commissioning Process to ensure that facilities perform as intended and provides analysis, recommends solutions, and cost effective alternatives for systems in need of repair or replacement. Maintains state-of-the-art knowledge in mechanical engineering, current codes and standards in order to apply current technology to policies in development, to update and review the NIH Design Requirements Manual (ORM) and to identify need for new or revised policies. Uses national codes and standards extensively to perform duties and justify decisions. Reviews project construction documents in accordance with the NIH Design Review Process to ensure compliance with the design criteria in the NIH Design Requirements Manual (DRM), international codes, standards, guidelines, and industry practices required to build quality facilities within a specified budget and schedule. Develops plans and specifications for various construction and maintenance projects. Performs construction site visits for projects on and off campus to observe and report on technical features of all features within the mechanical engineering field. Provides recommendations and reports when necessary. Desired Skills & Experience Applicants must show successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree that included a major field of study in engineering. A combination of education and experience--college-level education, training, and/or technical experience that furnished (1) a thorough knowledge of the physical and mathematical sciences underlying professional engineering, and (2) a good understanding, both theoretical and practical, of the engineering sciences and techniques and their applications to one of the branches of engineering. This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. BENEFITS: The federal government offers a comprehensive benefits package including vacation, sick leave, holidays, life insurance, health benefits, and participation in the Federal Employees Retirement System. For more information, check out New Employee Benefits at NIH and OPM's Employee Benefits Information http://hr.od.nih.gov/Benefits/permanentemployee.htm...

Sr. HVAC Engineer (Building Systems)

van Zelm Heywood & Shadford, Inc. is seeking Senior HVAC Engineer Senior HVAC Engineer will be responsible for development of system concepts, heating and cooling load analysis, equipment selection, and layout of air distribution, chilled water and hot water systems. Candidates must have graduated from an accredited college or university with a B.S. in Mechanical Engineering. Candidates will have established a minimum of 8-10 years experience in the engineering design, field and installation of building systems for: Corporate & Institutional Colleges & Universities Hospitals & Healthcare Pharmaceutical & Biomedical Facilities Arts & Culture and Historic and Adaptive Reuse Strong written and oral communication skills are also required as well as proficiency with AutoCAD and experience in production of contract drawings and specifications. A Professional Engineering license is desirable. If you are interested in applying for SENIOR HVAC ENGINEER please be sure you meet the qualifications listed. For more information about van Zelm Heywood & Shadford, Inc . please visit our website www.vanzelm.com Company Profile: Engineering excellence since 1930, van Zelm Heywood & Shadford, Inc. has been developing creative solutions to mechanical and electrical engineering problems for clients throughout the United States. Through the integration of architecture and technology van Zelm designs building infrastructures that improve the quality of life in a way that balances the needs of the individual, society and the environment. van Zelm has been devoted to the planning, design and study of MEP systems for the environment. We have received recognition for the design excellence in a variety of projects. van Zelm offers: Complete Mechanical and Electrical Design Sustainable Design Power and Utilities Strategic Energy Planning, Management & Conservation Commissioning Construction Administration Master Planning Diversified project portfolio including, commercial, education and healthcare markets Exciting and innovative projects We offer a competitive salary and benefits program including: Health and Dental Insurance 401(k) Savings Plan and Roth 401(k) Life / Disability Insurance Holidays Paid Time Off / PTO Flexible Reimbursement Accounts and Health Savings Accounts Tuition Reimbursement Business Casual Professional Registration Society Memberships Credit Union Membership Qualified and Interested Candidates Should Send Resume, Cover Letter VISIT US: www.vanZelm.com van Zelm Heywood & Shadford, Inc. is an Affirmative Action / Equal Opportunity Employer and is strongly committed to all policies which will afford equal opportunity employment to all qualified persons without regard to age, ancestry, color, marital status (including civil union status), national origin, race, religious creed, sex, sexual orientation, veteran status, mental retardation, learning disability, present or past history of mental disorder, or physical disability including, but not limited to, blindness, unless it is shown that such disability prevents performance of the work involved. Our policy and practice applies to all persons, particularly those who are members of the protected classes identified as being Black, Hispanic, Women, and Persons with Disabilities and others such as Asian, Native American, etc. van Zelm Heywood & Shadford, Inc. will implement, monitor, and enforce our Affirmative Action / Equal Opportunity Policy Statement and program in conjunction with all applicable Federal and State laws, regulations and executive orders. AA / EEO M / F / D / V * * * We ask that NO AGENCIES respond to this opening. * * * * * * NO SOLICITATIONS PLEASE * * * Key Words: M/E/P Engineering Mechanical Engineer, Engineer, Engineering, MME, materials engineering, design and manufacturing, mechanics, dynamics and systems, thermal systems, thermodynamics, System Engineer, systems engineering, MEP, M/E/P, plumbing / fire protection, architecture, LEED, LEED AP, LEEDAP, green, green design, environment, environmental engineer, design engineer, sustainable design, power and utilities, Strategic Energy Planning, Management & Conservation, Commissioning, Construction Administration, Master Planning, designs building infrastructures, MEP systems, Corporate, Institutional, Colleges, Universities, Hospitals, Healthcare, Pharmaceutical, Biomedical Facilities, Adaptive Reuse, AutoCAD, CAD, contract drawings, specifications. Professional Engineering license, system concepts, heating and cooling, load analysis, equipment selection, air distribution, chilled water, hot water systems, electrical systems, electrical infrastructure, power distribution, lighting design, fire protection systems...

Supplier Quality Engineer

Overview: This position is responsible for the development, documentation, and management of Supplier Quality Assurance and Control processes as required to support facility/division/corporate quality objectives. This position will act as the Supplier quality consultant to transfer project teams, and will lead projects to resolve supplier quality issues. This position is also responsible to manage the BES-Dymax Material Review Board, to participate in qualification efforts for new suppliers, to monitor and report on supplier performance of existing suppliers, and to perform on-site audits of supplier quality systems. Summary of Position with General Responsibilities: ?Lead the BES-Dymax Material Review board and assist in the investigation of component defects and failures. ?Participate on New Product Development and Project Transfer teams to facilitate the approval and transfer of suppliers into the BES-Dymax supplier management system. ?Assist Materials and Engineering in the selection of new suppliers and conduct qualifications and/or surveillance audits of new or established suppliers to BES. ?Track supplier performance and prepare and issue monthly reports of supplier and material quality performance, issues, and actions. ?Issue Supplier Corrective Action Requests as appropriate in response to detected supplier quality trends, and follow-up with suppliers on root cause investigation and closed loop corrective action. ?Plan and perform component, supplier, and process qualifications including First Article Inspections and the preparation of written test protocols and reports. ?Provide supplier related quality assurance sustaining engineering support to established product lines. ?Work with suppliers to identify and support process and product improvements in support of quality and cost improvement projects. ?Develop quality inspection processes, tests, techniques, tools, and fixtures, and train the production, service, and quality control staffs as needed to perform their respective duties. ?Develop written quality plans, quality inspection and test procedures. ?Create and review Risk Assessments and Rework Plans for component and product related issues including use-as-is and rework dispositions. ?Design and conduct Quality Engineering studies to determine causes of quality non-conformances, initiate changes in process, tooling, product design, etc. to correct them. ?Other duties as assigned....

Utility Operator/Stationary Engineer (4396)

The Jackson Laboratory is an independent, nonprofit biomedical research institution and National Cancer Institute-designated Cancer Center based in Bar Harbor, Maine, with a facility in Sacramento, Calif., an institute for genomic medicine planned in Farmington, Conn., and a total staff of about 1,400. Its mission is to discover the genetic basis for preventing, treating and curing human disease, and to enable research and education for the global biomedical community. The Laboratory is the world's source for more than 5,000 strains of genetically defined mice, is home of the mouse genome database and is an international hub for scientific courses, conferences, training and education. The Jackson Laboratory is seeking an experienced Stationary Steam Engineer to join the Facilities Maintenance and Operations team. Our plant is always growing and we are seeking enthusiastic engineers to operate and maintain our complex plant in Bar Harbor while being part of a tight knit crew. Key Responsibilities Include: Responsible for operation and maintenance of a complex and modern high pressure steam plant, chill water plant, and emergency electrical generation to include:Documentation of plant condition, maintenance, and status via equipment rounds, fuel and water meter logs, preventative and corrective maintenance using our CMMS software, and keeping a detailed log book in the control room. Very unique Suspended Wood Powder Combustion 1200hp, 300 psi pellet boiler with a 600kW back pressure steam turbine, 1600hp of LPG fire tube 85 psi boilers with associated vaporizers, and 1500hp of fuel oil fire tube 85 psi boilers. Responsibilities of operation and maintenance of associated supporting plant equipment such as condensate pumps, feed water pumps, steam pressure reducing stations, steam traps, air compressors, and boiler water chemistry amongst others. 5,500 tons of chiller capacity from x4 low pressure units, x2 steam absorption units, and x3 high pressure units including associated supporting plant equipment such as towers, pumps, and water chemistry. 4.25Mw of emergency diesel generation capacity. Documentation of plant condition, maintenance, and status via equipment rounds, fuel and water meter logs, preventative and corrective maintenance using our CMMS software, and keeping a detailed log book in the control room. Working up to personal ability level in other Maintenance trades as a first responder to after-hours facility related issues. Work will require shift work as part of a 24/7/365 operation with occasional required or optional overtime....

Systems Engineering Manager (D14-046)

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

Senior Product Development Engineer

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

Senior Product Development Engineer - Sports Medicine

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

Validation Engineer IRC7095

Validation Engineer IRC7095 Department Description: Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices. Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART" Brief Description: Qualified candidates must be experienced in one or more of the areas of validation: Utility Qualification Equipment Qualification Computer System Validation Cleaning Validation Method Validation Process Validation Responsibilities associated with this position are directly associated with the introduction and launching of new or products and processes into a turn-key manufacturing facility. The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The candidate must obtain technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle. The candidate must be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. Gown qualification is a plus, with an understanding of clean room practice and cGMP environments. The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting. SUPERVISION RECEIVED: Under direct supervision of the Manager, Validation Engineering SUPERVISION EXERCISED ? Validation Consultants Detailed Description: ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation. Must be able to read and understand engineering P&ID?s and turnover documentation. Work with project teams to develop DOEs and statistically sound tests for appropriate support of results. Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate. Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments. Develop statistically based sampling plans for in-process and final test sequencing. Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. Support and address comments and suggestions associated with validation and engineering documentation. Change control, non-conformance and CAPA support. Participate in FDA inspections, ISO certifications, surveillance audits and customer audits. Identify and implement opportunities for continuous improvement....

Design Control Engineer

Engineer will be responsible for reading through legacy data and reports to ensure that all documentation meets company criteria. This data will include design history files, design history reports, FDA data, and identifing gaps in the information. Engineer may also be responsible for writing additional protocols and testing of products. Must have an engineering degree in mechanical, biomedical, or chemical engingeering with 2-3 years of exeperience outside of school. Experience in the medical device industry or othe regulated environments is highly prefered. 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 ....

Modeling and Simulation Engineer

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

Quality Engineer II - CEE Lab

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

Sr Principal Packaging Engineer - Sterile Finished Products

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

Development Scientist

The Development Scientist will research, design, prototype, and productize new MRI techniques. This position will work on small teams to create new software and to maintain existing software for Toshiba MRI scanners and collaborate with other international team members and external research partners. Primary responsibilities include: Support an applications team developing prototype and product pulse sequences (Windows platform) Create and optimize scan protocols to meet clinical requirements in each clinical application Create, implement, test and report per functional specifications Technical support of clinical research colleagues, customers, users, sites and operation of Toshiba MRI Research technical and clinical trends in the industry and medical community in order to develop future product strategy...

Clinical Engineer

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

Sr. Product Development Engineer

Job Classification: Full-Time Regular Connect confidentially with MRIGlobalMedDevice at: Our client is a medical device organization located in eastern Tennessee. They have a critical need for a QA/RA Director so this is a great opportunity to make a strong impact and add immediate value. There is a strong team environment and great growth potential within the organization. Relocation assistance provided if necessary. Essential job responsibilities include, but are not limited to: Initiates and monitors the entire design process. Ensure that EN-13485 and FDA GMP Design Control requirements are adhered to per the Quality Manual. Prepare Capital Expenditure Requests as needed for new projects. Prepares detailed component and product drawings on CAD (Computer Aided Design). Directs and coordinates manufacturing or building of prototype products, if necessary. Creates and maintains ?Design History File? for all engineering projects. Analyzes test data and reports to determine if design meets functional and performance specifications. Participates in new product development teams and product launch teams to facilitate the introduction of new products. Applies engineering theory and problem solving techniques to address product deign, mechanical, and fabrication issues....

Biomechanical Engineer

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

Senior Staff Quality Engineer

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

Electronics Tech (Medical)

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

Vehicle Safety Supervisor

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

Senior R&D Engineer - Medical Device

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

Staff Engineer

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

Quality Control Engineer

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

Mechanical Project Engineer

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

Field Service Engineer (215260-017)

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

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....

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...

Manufacturing Engineer II

Pioneering Therapies, Transforming Lives. What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Manufacturing Engineer II to work with our innovative Manufacturing Engineering team in Sunnyvale, CA. The Manufacturing Engineer II will perform complex activities in providing manufacturing engineering support of existing circulatory support products and the development/transfer into manufacturing of new products. Provide technical solutions to a wide range of difficult problems. Responsibilities: This position is responsible for, but not limited to, the following: Work with cross-functional teams to transfer new products efficiently and effectively into manufacturing. Provide critical assessments of new product/component designs regarding DFM/DFA/DFT principles. Work with various internal and external organizations as required developing manufacturing processes or resolving technical issues w/ on-going products. Improve/design existing/new equipment/fixtures/gauging based on product and manufacturing/QA/R&D requirements. Develop and validate manufacturing processes (including identification, design, installation and validation of equipment) for fabrication of products in a clean room environment. Review technical drawings for appropriate dimensions and tolerances for the application. Develop effective fabrication, in-process control, and final quality test procedures. Develop manufacturing process flow diagrams, pFMEAs and process validation procedures. Aid in the selection, evaluation and ramp up of contract manufacturers. Perform process characterization studies. Collect and analyze in process data to evaluate capability and determine areas for process improvement. Drive process improvements and validations through manufacturing implementation. Provide technical support to manufacturing and QA to improve productivity and reduce costs. Participate as a manufacturing support member on cross-functional project team(s). Evaluate process capabilities, cycle times, yield, throughput, labor standards, and environmental impact. Participate in vendor evaluations re: manufacturing capability and capacity, engineering support and overall process quality controls....

Mechanical Test Lab Engineer

MED Institute, Inc. is currently accepting applications for a Mechanical Test Lab Engineer to become a part of our growing Nonclinical team. Responsibilities The three primary roles of this position include: Feasibility testing to support the product development of medical devices; Design verification testing to support device regulatory approval; and Post-market device evaluation to support clinical and/or marketing activities. This position requires a technically sound engineer capable of challenging medical devices through accelerated fatigue, corrosion, electrosurgical, simulative use, and basic mechanical properties medical device testing. In addition to developing and validating test methods and conducting tests compliant with various international regulatory agencies, this person will also be responsible for the maintenance of well-controlled documentation, including written protocols, data forms, and laboratory notebooks. Other activities, but not limited to, may include test matrix development, standard committee involvement, and research related to defining clinically relevant test conditions. Essential Qualifications M.S. in Mechanical/Biomedical Engineering required. A hard-working, enthusiastic, detail-oriented person with strong written and verbal communication skills, recordkeeping and interpersonal skills is needed. Will be working in a team setting and must be willing to be trained....

Senior Commissioning & Qualification Engineers

PSC Biotech is a leading life sciences consulting and IT services company. For over 15 years we have been engaged in providing project, process, IT, engineering and validation support to top-tier pharmaceutical and biotech companies. PSC is seeking experienced (1) Senior Commissioning and Qualification Project Engineer Lead and (4) Commissioning and Qualification Engineers for our client in the East Coast Area in Puerto Rico. Responsibilities Manage qualification and commissioning activities to meet timelines. IQ/OQ/PQ (Installation, Operational, & Performance Qualification) protocol test scripts. Commissioning and Qualification of: HVAC Systems, CIP Systems, Autoclaves, Process Equipment Incubators, Refrigerators, Incubators, walk in freezers, Facilities, Utilities, Electrical, Computer Systems (AHU controls), etc. System Risk Assessments Work closely with Construction Management Services and Engineering Services. Ensure compliance with FDA, cGMP and other appropriate regulations, as required....

Level I Validation Engineer/Specialist

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

Sr. Software Engineer

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

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...

Consultant- Technology Specialist- Semi Conductor

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

Principal Quality Engineer - Lenexa, KS

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

Principal Process Engineer

Principal Process Engineer Job Category: Research & Development Instrumentation Laboratory (IL) is a multinational company, a world leader in the development of in-vitro diagnostic reagents and instrumentation. Since its founding in 1959, IL has led the rapidly evolving markets of clinical diagnostic systems for blood gas and electrolytes analysis, hemostasis, and clinical chemistry. IL?s renowned medical technology is used every day in hundreds of hospitals and laboratories around the globe. It is IL?s focus on its customers-and on the patients whose lives are touched by its products-that is guiding the company into the next century. Position Description: Develop and improve manufacturing methods, systems, and processes to produce a high quality product at optimal cost. Act under general supervision of Process Engineering Management on multiple assignments of complex nature and broad scope. ? Concurrent Engineering:Support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. ?Documentation: Define and generate all required documentation in support of manufacturing products and processes. These include: Engineering protocols, FMECAs, reports, manufacturing instructions and procedures. Ensures compliance with cGMP's and internal protocols. Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations. ?Equipment and Fixturing:Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. Collaborate on design with suppliers to fulfill equipment and fixturing requirements. ?Qualification and Validation: Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Applies six sigma methodology as appropriate. ?Continuous Improvement and Cost Analysis:Continually improve manufacturing methods/systems and process/ product improvements to optimize product performance and reduce manufacturing costs. Identify and evaluate opportunities for improvement and make specific recommendations for adoption. Perform cost analyses to reduce or optimize product costs. ?Leadership: Lead team in operations related programs including product iterations, cost reduction programs, process changes across product lines and manufacturing layout synergies. May lead work of lower level engineers and I or technicians and provide performance input to reviewing manager. Qualifications: ?B.S. in Engineering, M.S. preferred ?Broad knowledge and experience with electro-mechanical, biomedical, and chemical manufacturing processes ?Minimum of 7- 10 years in process development and sustaining role in R&D or manufacturing or equivalent Desired/Preferred Qualifications: ?Knowledgeable in lean manufacturing principles and six sigma methodology ?IVD and/or Medical device manufacturing or manufacturing in highly regulated environment ?Excellent oral and written communication skills, including presentation skills ?Excellent PC skills, Excel, Project, Visio, Minitab, etc. ?Project management experience ?Proficient at interfacing with suppliers, engineers, scientists, and/or contractors effectively communicating requirements resolving conflicts and achieving objectives ?Solid interpersonal skills and ability to work in a team environment ?Proficient in statistical and financial analysis ?Demonstrated experience in the transfer of new products into manufacturing ?CAD skills If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Apply Now Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V *cb...

Product Manager - Medical Device

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 Manager 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 Manager 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 Manager 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...

Senior Computer Repair Technician

This position reports to the Computer Operations Manager to provide internet, intranet, application, and hardware system support to the College of Medicine students, staff and faculty. Provides customer support utilizing a web-based help desk database system. Performs initial setup and configuration of computer hardware and software. Provides technical assistance, training, and support to all College of Medicine staff and university affiliates with respect to in-house and vendor-developed applications. Initiates routine diagnostics and troubleshooting methods to isolate system failures. Supports the College of Medicine internal and external data collection and reporting needs. Works with a team that builds cooperative relationships with the faculty, College of Medicine administration, biomedical researchers, university administration, and the off-campus health sciences community; and participates in local, state, regional, and national professional associations. Duties associated with the Help Desk/Customer Service aspects of the position include, but are not limited to: - Answer help desk phone/assist users in resolving issues and training users on software. - Initiates routine diagnostics to isolate system failures. - Create trouble call tickets and assign to appropriate personnel. - Follow up on all open and closed tickets to ensure timely and effective resolution of issues. - Develop user guides and procedure manuals for specialized computer applications or training purposes....

Engineer 1, Hardware-US - NY - Rochester - CNP

Ortho-Clinical Diagnostics, Inc. (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company has approximately 3,800 employees around the world serving the global clinical laboratory and transfusion medicine community, and is committed to providing customers with products, services and process solutions to make labs more efficient in delivering the quality test results doctors and patients need. OCD was recently acquired by global alternative asset manager The Carlyle Group as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide Ortho Clinical Diagnostics a global company, is recruiting for an Engineer 1, Hardware in our Research & Development Organization located in Rochester, NY. The Engineer I, Hardware reports to the Hardware Engineering Manager within the Research & Development Systems function. Participates in Design Engineering Function responsible for development of hardware,designs from concept through transfer to manufacturing as well as significant post-launch design changes for current products. Responsibilities include participating in development of processes, process improvements, and staying up to date with latest design tools and practices. Is responsible to continually improving relevant engineering and leadership skills;conduct or manage deliverables, analysis or processes.Ensures completion of activities balancing quality, cost and time.Demonstrates a strongability to work as a systems engineer. Is responsible for leading laboratory automation development with external manufacturers. Requirements: Requires a minimum of a Bachelors Degree. Applicants who exhibit core competencies in one of the following fields: electrical engineering mechanical engineering chemical engineering biomedical engineering chemistry Requires at least 1 year ofequipment development experience.Medical Device Product Development experience is preferred. Demonstrated ability to work as a systems engineer in a team environment. Excellent verbal, written and presentation skills are required. Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively. Experience in identifying and resolving problems for Medical Device instrumentation. Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law. R&D...

Business Systems Analyst

Our prestigious medical client is in need of a seasoned Business Systems Analyst with extensive experience in workflow and business process design. The Business Systems Analyst will be involved in new development efforts as well as helping to resolve production issues. Day-to-day contributions for this role will include: Working with customers to expose the root cause of issues as opposed to just the symptoms or solutions that the customer describes. The BSA will then use this information so that the team can define a technical solution that maximally addresses the customer needs. Working with the technical team to translate customer's desires into an optimally defined technical solution. Producing clear functional specifications to ensure success and traceability across the development cycle ? design, development, QA and user acceptance. Generates applicable artifacts. Defining information architecture requirements to ensure overall design adheres to best practices for the user experience and implementation. Work with technical team to identify the root cause and alternatives for resolving production systems issues Communicate with the customer to determine a path forward and risk mitigation....

Materials Manager

Under the direction of the Clinical Director, the OR materials management coordinator is responsible for the day-to-day management of the supply procurement and patient billing activities Scrub tech experience a plus Responsibilities: Complies with accreditation and regulatory bodies and commissions in relation to operating room materials management Attends all required safety training programs and can describe his/her responsibilities related to general safety, center/service safety, and specific job-related hazards Follows the center exposure control plans/bloodborne and airborne pathogens Oversees the maintenance of materials management and center records Monitors equipment control including maintenance and repair in collaboration with biomedical engineer Assists in preparation of material and service budgets Collaborates with Clinical Director to negotiate competitive pricing with vendors Develops a system for inventory management Promotes effective working relations and works effectively as part of a center/unit team inter- and intracenter to facilitate the center's/unit's ability to meet its goals and objectives Demonstrates willingness to identify and/or assume activities relative to the developmental needs of the center and the organization Controls operating room inventory Responds to Business Office Manager and billing concerns Develop materials management and patient billing policies and procedures for the operating room region in accordance with center policies and procedures Qualifications: High School Diploma Basic computer skills Good phone etiquette The ability to multi task Excellent organizational skills CPR-AED on hire or within 90 days of hire...

Project Manager

A Project Manager provides leadership to the task force to ensure timely completion of all activities and deliverables during the various stages of multidisciplinary design projects. The project manager is responsible for the technical integrity of the design deliverables as well as management of the project scope of work, project engineering budget, design schedule and client relation management. The projects may vary in size and nature, but are mainly in the area of small to medium capitals works, plant engineering and improvements to mill or plant operations. Besides project execution activities, the project manager takes leadership in the development of competitive proposals which outline and define project scope of work, design deliverables, engineering effort-hour and engineering cost estimates....

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