- Fresenius Medical Center (Lawrence, MA)
- …SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non-medical software device engineering teams to ensure compliant ... **PRINCIPAL DUTIES AND RESPONSIBILITIES** . Works as part of software development team on new product development or on...well as design changes . Partners with and/or guide software project teams to ensure that software … more
- Meta (Cambridge, MA)
- …systems for our AR, VR, and wearable devices, working on low-level systems software , device drivers, and connectivity protocols such as Wi-Fi, Bluetooth, and ... experts is developing and shipping products at the intersection of hardware, software , and content, pushing the future of computing platforms and redefining the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …% **Preferred:** + MS in engineering or life sciences preferred. + Experience with medical device software , including software in a medical device (SiMD) ... and support submissions related to digital health technologies, including software , and connected systems. Working closely with the DU's...and software as a medical device (SaMD), preferred. + Knowledge of regulatory submissions such… more
- Hologic (Marlborough, MA)
- …and maintaining robust CI/CD infrastructure and development tools to support high-quality medical device software delivery. This role requires you to bridge ... especially SVN and Git, including migration strategies. + Familiarity with medical device software development standards and regulatory frameworks (eg, IEC… more
- Oracle (Boston, MA)
- …self-healing, and scalable processes. + Serve as the escalation authority for device performance, software /firmware issues, and field incidents. + Author ... roadmaps, investment cases, automation strategies, and device standardization documents. **KEY RESPONSIBILITIES:** + Develop, communicate, and execute the global… more
- MPR Associates (Burlington, MA)
- …to stretch into application development to support the full suite of software for device implementations. Duties/Responsibilities + Embedded Systems Development: ... is actively seeking a capable and motivated Embedded System Software Engineer to join our team. If you are...Description Join our engineering team as an Embedded System Software Engineer where you'll develop connected embedded systems and… 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 Quality ... for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device for the US and Rest Of World region (excluding EU,… more
- Sanofi Group (Cambridge, MA)
- …a wide range of digital health technologies (DHTs), from digital biomarkers, wearables, software as a medical device (SaMD), connected devices and other ... **Job Title:** GRA Device Lead (Associate Director) - Digital Health **Location:**...markets. Working knowledge with technical/industry standards related to eg, software development lifecycle, design controls, labeling, software … more
- Medtronic (Boston, MA)
- …**Compliance** - Ensure compliance with industry standards and regulations related to medical device and health software product security, such as NIST, IEC ... critical role in ensuring the security of Medtronic Surgical Operating Unit medical device solutions. Reporting to the Director of Product Security, this role drives… more
- Evolv Technology (Waltham, MA)
- …system testing for Express and Expedite. + Evaluate product behavior across on- device software , hardware modules, and Portal connectivity. + Validate new ... in a dynamic, fast-paced environment testing both hardware and software ? Do you want to help validate new hardware,...you want to help validate new hardware, firmware, and software for Evolv's Express and Expedite products-and play a… more