- Oracle (Augusta, ME)
- …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 (Little Rock, AR)
- …. 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 (Helena, MT)
- …. 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
- Hologic (Newark, DE)
- Senior Software Engineer, Medical Device Newark, DE, United States Located in Newark, DE, **Hologic** 's Innovation Center is continuing to offer job ... opportunities. We are seeking a **Senior Software Engineer (C#/ .NET, Full Stack)** to design, develop,...secure coding principles or cybersecurity is a plus. + Medical device experience is a plus. +… 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
- US Tech Solutions (San Bruno, CA)
- …system issues. **Mandatory:** + 5+ years of experience in program management. + Experience in Medical Device Manufacturing or Software as a Medical ... screening. + The team develops and deploys hardware and software solutions to help screen for vision threatening eye...+ Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring… more
- US Tech Solutions (San Bruno, CA)
- …frameworks, and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in ... experience in standalone software development, with a solid understanding of medical device software standards such as IEC 62304. ** Software Quality… more
- Bayer (Indianola, PA)
- … development processes, software architecture, data structure and compliance as it relates to medical device software and software as a medical ... product including Device Software Solutions, Class I and II Software as a Medical Device Applications; + Provide technical advice to the Cevego … more
- Fujifilm (Bothell, WA)
- …engineering practices and processesfor medical devices + Demonstrated experience developing medical device software compliant with IEC 62304 + Experience ... the resolutions meetperformance requirements andcustomer expectations. + Producesoftwarearchitecturedocumentationincompliance with medical device development standards. + Stay abreast… more
- Globus Medical, Inc. (Audubon, PA)
- …to the latest tools and methodologies in C++ development, robotics integration, and medical device software , with opportunities for continuous learning and ... and components for medical or robotic applications + Familiarity with medical device development, including regulatory and safety considerations, is highly… more
- Stryker (Orlando, FL)
- … Device (SaMD)/ Software in a Medical Device (SiMD) and non- medical device software to support projects as a quality engineer for post-market ... Power BI or similar tools for basic data visualization and monitoring. + Exposure to Software as a Medical Device (SaMD), Software in a 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
- 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
- Hologic (Newark, DE)
- …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
- Stryker (Redmond, WA)
- …code/vulnerability analysis and bug tracking tools. + Create efficient deployment processes for medical device software and ensure compliance with industry ... within the SDLC. + Familiar with regulatory and compliance standards relevant to medical device software , including IEC 62304, ISO 13485, and the FDA's… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …team of talented software engineers in the development and delivery of innovative medical device software solutions. This role is critical in driving ... + Proven experience managing software development teams in the medical device industry, with a strong understanding of regulatory requirements (eg, FDA 21… more
- Philips (San Diego, CA)
- …HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software . + Serving as SME for Software Design ... etc.) + 8+ years of experience in Software Quality and/or Software Development in medical device industry with hands on experience with SW Design… more
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