- Hologic (Marlborough, MA)
- …department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, ... uncontrolled risks with potential impacts on patient safety. + Perform Security Risk Management activities to address identified vulnerabilities and security… more
- Insight Global (Westborough, MA)
- …and documentation skills. Experience supporting tools in a medical device or health-tech environment. Familiarity with test management and requirement ... platforms used throughout the software development lifecycle (SDLC) of Software as a Medical Device (SaMD). This includes tools such as Jama Connect… more
- Guidehouse (Boston, MA)
- …program design, implementation, and monitoring services to pharmaceutical, biotechnology, and medical device , companies. We support our clients across the ... particularly for specialty medications (eg, high cost, biologics, CAR-T, REMs, drug- device combinations), Organizational design and change management , and… more
- J&J Family of Companies (Danvers, MA)
- …team + Manage and develop supply chain phase-in plans accounting for various medical device regulatory approval timelines + Qualify and implement dimensional and ... continually and constructively challenging the status quo + Basic understanding of medical device regulatory submissions + Dedicated, passionate and eager to… more
- Olympus Corporation of the Americas (Westborough, MA)
- … to make solid decisions with long-term impact. He or she must fully understand medical device design control requirements and be able to effectively guide a ... Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill… more
- J&J Family of Companies (Danvers, MA)
- …inputs into software specifications. + Design, development, and test software per medical device software development life cycle (IEC-62304) + Participate in ... and provides updates on project status to team and management . Management of small to mid-size projects of...would be a big plus. + Experience in the medical device industry is strongly preferred. +… more
- Teradyne (North Reading, MA)
- …project briefings. + Establish and maintain integrated project plans, schedules, risk management frameworks, and performance metrics to ensure program ... powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device… more
- Insight Global (Bedford, MA)
- … management , and design changes. - Strong grasp on Middleware solutions - Medical Device Data management experience - Experience with tools: Jira, ALM, ... improvement initiatives. Provide technical input in areas such as risk management , V&V, and cybersecurity. We are...of degree. - Minimum 8 years of experience in medical devices, pharmaceuticals, diagnostics, or clinical labs; or 5… more
- Takeda Pharmaceuticals (Lexington, MA)
- …contract terms that balance overall deal benefit with acceptable levels of risk and profitability across Takeda's supply chain and manufacturing network. **General** ... executive leadership, including pre-governance socialization of proposed deals emphasizing risk /benefit trade-offs, deviations from originally envisioned deal structure, … more
- Sanofi Group (Cambridge, MA)
- …year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device /biotech industry + Knowledge and understanding of complex ... marketed products, to meet both short- and long-term business objectives while mitigating risk . Consults with senior management and provides input to the Global… more