- 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
- 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
- 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
- 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
- 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
- Jacobs (Boston, MA)
- …and as-built processes; verify construction install with model based practices; create project processes and lead mobile device trainings for field employees; ... are seeking an experienced Virtual Design & Construction (VDC) Engineer to manage and optimize our digital delivery processes...and client goals and define digital delivery scope for project estimates, and coordinate project technical setup… more
- Actalent (Newton, MA)
- …and establish best practices for electrical engineering development within a regulated medical device environment. Responsibilities + Lead and resolve complex ... Job Title: Principal Electrical Engineer Job Description Join our innovative R&D organization...document, and maintain detailed processes and best practices for medical electronics development. + Design, document, and execute electronic… more
