- 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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …+ Demonstrated expertise in applying FDA design control requirements (21 CFR ) as applied to medical device software and medical device regulation ... **Job Description** We're looking for a Principal Software Engineer to join our growing team and...with states and local laws. **Company benefits** : Comprehensive medical , dental, vision, prescription drug coverage, company provided basic… more
- Abbott (Pleasanton, CA)
- … Engineering organization. Accountable for delivering scalable, reliable, high-performance, innovative medical device software and non-regulated digital ... Degree preferred. + Software development experience required in medical device , digital health, and/or other highly regulated industry. + Previous experience… more
- Abbott (Alameda, CA)
- …as they apply to the development, verification, validation, use, and maintenance of medical device software . + Coordinate activities with other engineering ... to the development, verification, validation, and maintenance of application in support of medical device software . + Software Quality lead in various… 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
- Philips (San Diego, CA)
- …if:** + You have a minimum of 8+ years' experience in FDA regulated, IEC 62304 medical device software environments (SiMD/SaMD), with a focus on Software ... stand-alone software projects (SaMD) as well as software -related aspects of complex medical systems (SiMD)....as well as software -related aspects of complex medical systems (SiMD). Manages the development, oversight and execution… more
- Stryker (San Jose, CA)
- …Quality Engineer, Post Market** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD)/ Software in a ... Amazon, Google, Microsoft, or similar, demonstrating strong technical skills. + Experience with Software as a Medical Device (SaMD) and Software in a … more
- Caldera Medical (Westlake Village, CA)
- …with minimal oversight. * Strong analytical and problem-solving skills. * Experience with medical device software requirements and software regulations. ... as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies.… more
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