- Intertek (Boxborough, MA)
- Project Engineer - Medical Device Testing, Boxborough, MA Intertek, a Nationally Recognized Testing Lab (NRTL) and leading provider of quality and safety ... the top recognized brands and companies is actively seeking a Project Engineer - Medical Device Testing to join our Electrical team in Boxborough, MA.… 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
- 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 ... their health and get on with their lives. We are seeking an experienced Staff Engineer , Software Design Quality to ensure our medical devices are developed in… 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 HL7 Integration Engineer (IE) for Canadian region oversees all technical...must have expert level knowledge in all areas of medical informatics, IT infrastructure design and deployment, medical… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to the best of my knowledge. **Job Description** **Title: Senior/Principal Engineer , Combination Products and Drug Delivery Devices** **Location: Cambridge, MA** ... **About the role:** As a Senior/Principal Engineer , Combination Products and Drug Delivery Devices, you will...Combination Products and Drug Delivery Devices, you will provide project and technical leadership in the development, manufacturing, and… more
- J&J Family of Companies (Danvers, MA)
- …verification and validation plan and strategies while maintaining traceability. + Use Software as a Medical Device (SaMD) and Software in a Medical Device ... for the best talent for Sr. Software Design Quality Engineer role to be located at Danvers, MA.** The...of 5 years of related work experience within the medical device industry on SaMD and SiMD… more
- Amgen (Cambridge, MA)
- …automate model creation and post/processing. + Experience with combination products and device regulatory requirements, medical device development and design ... and transform the lives of patients while transforming your career. **Senior Engineer : Mathematical Modeling and Simulation** **Cambridge, MA** **What you will do**… more
- Medtronic (Boston, MA)
- …implementation, build, test, deployment and debugging of embedded software on a medical device + Architecting, implementing, and supporting an end-to-end CI/CD ... office in the Seaport District of Boston, MA, as a Principal DevOps Software Engineer you will lead and/or participate in supporting our CI/CD infrastructure for the… 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 Senior Upgrade Engineer is responsible for performing upgrades for Fujifilm...for performing upgrades for Fujifilm Healthcare Americas Corporation (HCUS) Medical Informatics (MI) products to all eligible sites. In… more
- Hologic (Marlborough, MA)
- …Are you passionate about ensuring the quality, safety, and reliability of life-saving medical device software? Hologic is seeking a **Lead Software Design ... Lead Software Design Assurance Engineer Marlborough, MA, United States Newark, DE, United...excellence in software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD).… more
- RTX Corporation (Andover, MA)
- …applications. Your subject matter technical expertise in reliability testing and characterization, device physics, and applied statistics is key to the success on ... this role. As a senior engineer , you will need to communicate efficiently and effectively...strong initiatives to go above and beyond + Push Device Reliability Function to a higher level through exploration… 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 ... process as well as design changes . Partners with and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …pacemakers or low-level analog signal equipment would be a strong plus + Familiarity with medical device safety agency approval processes such as UL or ETL a ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide...subsystems. May act in the role of lead electrical engineer (Task Leader) within a development team, group, or… more
- J&J Family of Companies (Danvers, MA)
- …This role will drive the scale-up and production of a complex electro-mechanical medical device used in life-saving cardiac support therapies. This role will ... preferred. + 6-10+ years of manufacturing engineering experience in electronics or medical devices ( device hardware, electronics assembly, or related fields). +… more
- J&J Family of Companies (Danvers, MA)
- …a related engineering discipline. + Minimum of 5 years of experience in medical device development (senior-level candidates often have more). + Demonstrated ... Johnson & Johnson is hiring for a **Sr Systems Engineer ** **-** **Abiomed** to join our team located in...design controls and traceability practices. + Solid understanding of medical device regulatory environment and standards (for… more
- Hologic (Marlborough, MA)
- …Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a **Lead Design ... Lead Design Assurance Engineer Newark, DE, United States Marlborough, MA, United...to hear from you! **Knowledge:** + In-depth understanding of medical device regulations and standards, including ISO… more
- Celestica (Boston, MA)
- …Celestica product design partners. + Understanding ISO 13485 requirements for medical device engineering changes. **Knowledge/Skills/Competencies** + An "out of ... and key characteristics that allow for substitution. + Understanding of IEC 60601-1 Electrical Medical Device Safety Standard. + Understanding of ISO 13485 as it… more
- Hologic (Marlborough, MA)
- …& Attributes:** + Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP. + ... Post Market Quality Engineer Newark, DE, United States Marlborough, MA, United...quality and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic's Breast and Skeletal Health Division… more
- Hologic (Marlborough, MA)
- …teams in the execution of design changes, product enhancements, and quality projects for medical device products. This position plays a vital role in ensuring ... experience, with a preference for 3 years in a medical device process and/or product development environment....Medical Devices Directive. + Effective team leadership and project management skills. + Strong knowledge of root cause… more
- Hologic (Marlborough, MA)
- …field required; Master's preferred. + Extensive understanding of engineering principles, medical device development, and customer-centric design. + Advanced ... Sr. New Product Development Engineer - Marlborough, MA Marlborough, MA, United States...in documentation and deliverables. **Experience** + 5+ years in medical device product development with a Bachelor's… more