- Intertek (Boxborough, MA)
- Project Engineer - Medical Device Testing, Boxborough, MA Intertek is a Nationally Recognized Testing Lab (NRTL) and leading provider of quality and ... quality, safety, and sustainability to life. What are we looking for? The Project Engineer is responsible for independently performing testing and evaluation on… more
- Amgen (Cambridge, MA)
- …team. Join us and transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What ... and New Product Introduction program milestones + Participate in project execution according to the Robust Design paradigm and...- ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong… more
- Takeda Pharmaceuticals (Lexington, MA)
- …support lifecycle management of commercial combination product. The Staff Device Engineer has extensive experience in medical devices for drug delivery ... of my knowledge. **Job Description** **Primary** **Role:** The Staff Device Engineer will lead technical efforts for...with medical device and combination device regulations. + Lead project execution activities… more
- Capgemini (Burlington, MA)
- …_ERD PPL US_ **Title:** _Senior Embedded Software Engineer - Test Lead (Embedded Medical Device )_ **Location:** _MA-Burlington_ **Requisition ID:** _079670_ ... **About the job you're considering** Test Lead (Embedded Medical Device ) Test Lead to drive...requirements, use cases, and system specifications to fully understand project details and align test coverage with product expectations.… more
- Globus Medical, Inc. (Methuen, MA)
- …surgery so patients can resume their lives as quickly as possible. **Position: Project Engineer - Systems** **Location:** Methuen, MA **Position Summary:** Our ... integrate electrical, mechanical, and software subsystems into a cohesive, high-performance medical device . + Identify and mitigate system-level risks through… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... **Position Overview** The LEAD PROJECT TEAM SUPPORT ENGINEER -MI provides remote...manages. + Maintains an expert working knowledge of current medical imaging products and related technologies. + May be… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Administer and implement design changes to bring the product to the regulated medical device market + Perform engineering analysis; conduct testing and data ... At Globus Medical , we move with a sense of urgency...with top surgeons and cross-functional engineering teams. The Electrical Engineer will be part of the electrical team responsible… more
- Fujifilm (Boston, MA)
- …of Synapse product implementation, fromsolution validation phases through product go-live. The Project Engineer (PE) must have wellrounded knowledge in all areas ... + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Fresenius Medical Center (Lawrence, MA)
- …REQUIRED SKILLS** + Minimum 7+ years' experience in electrical product development, medical device or highly regulated product development preferred. + ... Engineer is a technical member in the Fresenius Medical Care Research and Development group. This position is...including specification, documentation, and quality assurance + Experience in medical device safety and EMC compliance (IEC… more
- Amgen (Cambridge, MA)
- …experience with 5+ years of experience in operations/manufacturing environment. + Medical device industry experience and regulated work environment experience. ... the lives of patients while transforming your career. Senior Engineer **What you will do** Let's do this. Let's...Regulation - 21CFR820, Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC.… more
- Amgen (Cambridge, MA)
- …of progressive experience as an engineer or scientist in relevant fields ( medical device development, manufacturing, etc.) + Proven track record of executing ... various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key… more
- Takeda Pharmaceuticals (Lexington, MA)
- …relevant experience, Master's degree preferably within the biopharmaceutical industry or medical device development and commercialization is desired. + Hands ... releases. The ideal candidate will be a hands-on technical individual, providing project and engineering support in device and/or system identification,… more
- Medtronic (Newton, MA)
- …well-versed in designing, implementing, and managing DevOps practices within the healthcare, medical device , or robotics software industry. This includes deep ... potential to work a hybrid schedule.** As a Sr. Engineer , you will play a pivotal role in accelerating...DevOps and cloud space, particularly those relevant to the medical device and healthcare sectors **Required Qualifications**… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …devices. + Knowledge and experience developing products under FDA and European Community medical device regulations and standards. + Excellent verbal and written ... devices. + 7+ years' experience as a systems engineer , leading the architectural design and systems engineering of...and systems engineering of complex, real time embedded system medical devices. + Project management experience and… more
- Teradyne (North Reading, MA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device… more
- Fresenius Medical Center (Lawrence, MA)
- **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ensure ... as design changes . Partners with and/or guide software project teams to ensure that software systems are compliant...and data privacy . Compiles, maintains, and evolves approved project deliverables. . Communicates project and compliance… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... **Position Overview** An Imaging Service Engineer II is responsible for performing scheduled and...of this job: This position typically works in usual medical , clinical working environments, including sites under construction. **The… more
- Integra LifeSciences (Boston, MA)
- …related discipline with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years of ... and set new standards of care. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is...testing activities. The role works closely with Product Development, Project Management, Regulatory, Marketing and Medical Affairs.… more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Fresenius Medical Center (Lawrence, MA)
- …related to the design, development, and ongoing maintenance of NxStage' s software-based medical device products and supporting software The candidate will gain ... software test automation, Continuous Integration (CI), embedded systems, GUI systems, and medical device standards ISO 13485 Quality Management System and IEC… more