- Oracle (Boston, MA)
- …bridges product development, regulatory, and enterprise architecture functions-ensuring that device software solutions are designed securely, maintain regulatory ... of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven experience defining and… 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 software development sector. In this critical role, you will be responsible for… more
- Abbott (Burlington, MA)
- …EU Medical Device Regulations and MDSAP + Experience with medical device software development lifecycle for Cloud-based networks and/or mobile applications. ... their lives. We are seeking an experienced Staff Engineer, Software Design Quality to ensure our medical devices are...and state of the art standards. The Staff Engineer, Software Design Quality will serve as a technical representative… more
- Medtronic (Newton, MA)
- …the Greater Boston area or have the ability to relocate for the position The Senior Software Engineer will be a key player in the Affera Software Team, working ... proficiency in Python and C++, and have a deep understanding of software engineering principles, including object-oriented design, data structures, algorithms, and … more
- Oracle (Boston, MA)
- …of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety analysis, and ... (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device (SaMD). . Familiarity with Oracle… more
- Oracle (Boston, MA)
- …of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). . Strong understanding of clinical risk, safety analysis, and ... (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software as a medical device (SaMD). . Familiarity with Oracle… more
- Capgemini (Waltham, MA)
- …and workflow tools such as Bitbucket and Jira. + Exposure to medical device software or other safety-critical systems. **Preferred skills** + Basic scripting ... lines and releases. You'll work hands-on in lab environments-often with medical device systems-to ensure software modules function seamlessly together and meet… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Quality 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...diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality standards. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- … device setting. + Experience in the application of relevant standards to medical device software and non-medical device health software development, ... . **Job Description** This role provides professional expertise for Software quality and best practices in SW design, development, release,… 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 ... impact on healthcare innovation. **Knowledge:** + Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO… more