- Syner-G BioPharma Group (Boston, MA)
- …Experience: 4-7 years of experience within the biotech, pharmaceutical, or medical device industry.Knowledge and experience working with FDA cGMP, ... (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : Syner-G is seeking an experienced Process … more
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC ... product delivery while maintaining compliance and quality. + Provide project management oversight for QMS integration, Quality plans, process...+ Minimum of 6 years of experience in a medical device setting. + Experience in the… 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
