- Capgemini (Burlington, MA)
- …**Your skills and experience** + 5+ years of experience in application software development , with 2+ years in the medical device or other regulated ... Software Engineer - C++ / MATLAB (Med Device Product Development ) Choosing Capgemini means choosing...clinical outcomes. **Your role** + Design and develop standalone medical device applications using modern C++ on… more
- Philips (Cambridge, MA)
- …+ You have 4+ years in a role associated with healthcare and/or medical device and software development in a regulated environment. + You have experience ... changes. + Define and manage product roadmaps using Product Development Lifecycle Management frameworks, ensuring timely delivery and market...with Salesforce, RCM software , EHR integrations and SAP (a plus). + Your… 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 ... that enhance the usability and functionality of our advanced medical devices. The Principal Software Engineer will...and methodologies to drive efficiency and innovation within the software development team. **About the Affera Mapping… 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, ... devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device ...MDSAP, and global quality systems. + Strong background in software development life cycle, SaMD/SiMD validation, and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …data integrity. This experience is intended to build foundational skills in medical device development , cross-functional collaboration, and disciplined ... Description** Our DE&C function, part of Drug Product and Device Development in Pharmaceutical Sciences, is a...microscopy (SEM-EDS) is a plus + Experience in the medical device industry is a plus +… 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 ... across engineering, regulatory, and product leadership teams to align development activities with ISO 14971, IEC 62366, and EU/US...MDR, FDA 510(k), etc.). . Experience working with AI-driven medical device applications or software … more
- Oracle (Boston, MA)
- …Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development , etc. in medical device industry or equivalent. Experience ... in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will...who can keep up with the fast-paced environment of software development and an evolving regulatory landscape.… more
- Sanofi Group (Cambridge, MA)
- …support a wide range of digital health technologies (DHTs), from digital biomarkers, wearables, software as a medical device (SaMD), connected devices and ... (GRA) Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic (IVD) products… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and oversight for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that ... medical devices, including stand-alone devices, combination devices, and Software as a Medical Device ...At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class… more
- Danaher Corporation (Boston, MA)
- …9+ years of experience. + Industry Expertise: Extensive experience in medical device /diagnostics regulated environments across manufacturing, R&D, supply chain, ... senior leadership. + Project & Program Mgt Excellence: Lead the development , implementation, and continuous improvement of standard PMO/Project methodologies and… more