- Oracle (Sacramento, CA)
- …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
- Oracle (Sacramento, CA)
- …. 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 (Sacramento, CA)
- …. 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
- 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
- Stryker (San Jose, CA)
- … 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
- 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
- Abbott (Alameda, CA)
- … software application issues to ensure the reliability and safety of medical device software products. Perform thorough testing of mobile ... **Preferred Qualifications** + Experience in testing mobile/web applications (ideally in medical device industry). + Experience in writing, implementing and… more
- Stryker (San Jose, CA)
- …Engineer, Design Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in ... medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical … more
- Stryker (San Jose, CA)
- … Design Quality Engineer** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a ... medical device regulations (820, IEC 62304/82304, 60601), with experience in Software as a Medical Device (SaMD), Software in a Medical … more