- Oracle (Boston, MA)
- …and support the adoption of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven ... **Responsibilities:** As a Principal Member of Technical Staff for Medical Device Software , your key responsibilities include: + Architectural… more
- ICS (Waltham, MA)
- Senior Project Manager - Medical Device Software Waltham, MA Apply Now Senior Project Manager, Medical Device Software Role SummaryWe are seeking ... a seasoned Senior Project Manager with extensive experience in the medical device / regulated software development sector. In this critical role, you will be… more
- Abbott (Burlington, MA)
- …EU Medical Device Regulations and MDSAP + Experience with medical device software development lifecycle for Cloud-based networks and/or mobile ... product software (Cloud Patient Care Networks, mobile applications and embedded software ), non- medical software , and non-product software + Support … more
- Medtronic (Newton, MA)
- …hardware components. Experience with regulatory compliance and security protocols specific to medical software (eg, HIPAA, FDA regulations) is preferred but not ... interfaces that enhance the usability and functionality of our advanced medical devices. The Principal Software Engineer will be a key player in the Affera … more
- Oracle (Boston, MA)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device … more
- Oracle (Boston, MA)
- …. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety ... submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device … more
- Takeda Pharmaceuticals (Lexington, MA)
- …strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, ... medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality… more
- Olympus Corporation of the Americas (Westborough, MA)
- … medical device setting. + Experience in the application of relevant standards to medical device software and non- medical device health ... guidance, and leadership for the application of health and medical device SW regulatory standards to the...as a Subject Matter expert on regulations around health software development, and software for medical… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …self-sufficiency Experience with Scrum is preferred, but not required + Experience with medical device software development is preferred, but not required ... technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat… more
- Hologic (Marlborough, MA)
- …States Are you passionate about ensuring the quality, safety, and reliability of life-saving medical device software ? Hologic is seeking a **Lead Software ... meaningful impact on healthcare innovation. **Knowledge:** + Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820,… more