- Amgen (Cambridge, MA)
- …various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key ... Most of the designs will be in polymers. + ** Engineering Testing:** Responsible for engineering test protocol,...experience as an engineer or scientist in relevant fields ( medical device development, manufacturing, etc.) + Proven… more
- Fresenius Medical Center (Lawrence, MA)
- …REQUIRED SKILLS** + Minimum 7+ years' experience in electrical product development, medical device or highly regulated product development preferred. + ... development process, including specification, documentation, and quality assurance + Experience in medical device safety and EMC compliance (IEC 60601, CE, etc.)… more
- Fresenius Medical Center (Lawrence, MA)
- …alignment across the organization. + Provide planning and project management support for medical device product launches. + Assist in the development and ... years of experience as a Product Manager in a medical device field or (ii) Master's degree...device field or (ii) Master's degree in Biomedical Engineering or Bioengineering. Must also have had experience (which… more
- Abbott (Burlington, MA)
- …types of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory ... on product complaints to various teams (eg Regulatory, Quality Engineering ). The other role of the Post Market Surveillance...work experience **Preferred Qualifications** + 3+ years in MDR ( Medical Device Reporting) + Knowledge of the… more
- Fresenius Medical Center (Lawrence, MA)
- …for staffing and leading a team of software developers to deliver high quality medical device software. Develop and drive a long-term strategic vision for the ... in software development, verification, and standards necessary to meet global medical device regulatory requirements. + Clear understanding of Software… more
- Capgemini (Burlington, MA)
- …verification strategies, manage a team of engineers, and ensure compliance with medical device regulations. **Your Role** . Lead Verification Strategy: Develop ... & Standards: Ensure all verification activities align with relevant medical device regulations such as ISO 13485,...a plus. . Bachelor's or master's degree in computer engineering , Electrical Engineering , Biomedical Engineering ,… 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)
- …geometric tolerance analysis, and documentation is preferred + Strong understanding of medical device development processes + Able to communicate effectively, ... and/or testing of complex electro-mechanical products preferred + Prior medical device experience strongly preferred EO/AA Employer:… more
- Fresenius Medical Center (Waltham, MA)
- …regulatory compliance, quality engineering and auditing in the pharmaceutical or medical device sector or related industries + Several years of practical ... Fresenius Medical Care (FMC) is a people business. Our...Demonstrated expertise in specialized processes related to drug and device manufacturing, particularly in areas of sterilization, bag manufacturing,… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …frameworks and tools to verify the software within a software-driven electro-mechanical medical device + Design, develop, and support automated unit, ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more