- Abbott (Pleasanton, CA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... their health and get on with their lives. We are seeking an experienced Staff Engineer , Software Design Quality to ensure our medical devices are developed in… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …in control theory, signal processing, physiological systems, and algorithm development for medical device innovation. This is a critical role in shaping ... in control theory, signal processing, physiological systems, and algorithm development for medical device innovation. This is a critical role in shaping… more
- Amgen (Thousand Oaks, CA)
- …experience with demonstrated ability in operations/manufacturing environment + Experience in medical device , pharmaceutical or a similar regulated industry + ... regulations: + Quality System Regulation - 21CFR820 + Quality Management System for medical device /component manufacturers - ISO 13485 Risk Management for … more
- Stryker (San Jose, CA)
- …Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) ... maintained engineering documentation, including Design History Files, in accordance with medical device regulatory standards. + Demonstrated strong understanding… more
- Stryker (San Jose, CA)
- …** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) ... strong technical skills + Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), with experience in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …communication skills are required. + Demonstrated ability to facilitate the interface with medical device vendors and HF consulting firms. + Demonstrated ability ... together. Qualified candidates will focus on the development of devices and drug - device combination products such as pre-filled syringes and auto-injectors.… more
- Genentech (South San Francisco, CA)
- …and the drug therapy being delivered. The Principal Human Factors Engineer has strong experience in human factors engineering for combination products and/or ... That's what makes us Roche! **The Opportunity** The Principal Human Factors Engineer will be responsible for providing human factors engineering expertise to project… more
- US Tech Solutions (Thousand Oaks, CA)
- …of professional experience in highly regulated environment (strong preference for medical device , biopharma and/or combination product experience). + Experience ... Seeking candidates with experience in combination products, electromechanical systems, or medical devices, a background in pharma, and hands-on expertise in design… more
- Abbott (Sunnyvale, CA)
- …etc.) a plus. + Experience and knowledge of software development process as required for medical device industry a plus. + Experience with SVN, git, and JIRA. + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Stryker (San Diego, CA)
- …for Endoscopy products and features. + Research, design, develop, and modify medical device systems, including updates to existing platforms and new ... helping identify hazards, evaluate risk, and define mitigations in compliance with medical device standards. + Drive analytical studies (trade-off, sensitivity,… more