- Amgen (Thousand Oaks, CA)
- …other teams to support life cycle management. The Sr Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European ... management documents as required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations. + Creates and maintains… more
- Actalent (Irvine, CA)
- …conducting reviews and verifying implementation. Essential Skills + Experience with medical device product development lifecycle, including risk management and ... agencies (FDA, MoH, TUV, etc.). + Thorough knowledge of US and International Medical Device Regulations. + Strong knowledge of quality concepts (eg, CAPA,… more
- Teradyne (Agoura Hills, CA)
- …powering next-generation technologies through sophisticated solutions. Behind every electronic device you use, Teradyne's test technology ensures your device ... quickly, efficiently and cost-effectively. Together, Teradyne (http://www.teradyne.com/) companies deliver manufacturing automation across industries and applications around the world!… more
- Medtronic (Irvine, CA)
- …complex regulations including FDA QSR, CFR 820, ISO13485, ISO14971 and EU Medical Device Directive; Responsible for Risk analysis activities including health ... III medical devices. FDA QSR, CFR 820, ISO13485, ISO14971 and EU Medical Device Directive. Risk analysis activities including health hazard Assessment, Fault… more
- Broadcom (San Jose, CA)
- …with Design, Advanced Technology Research and Development, Fab and assembly Manufacturing to define semiconductor device reliability requirements, characterize ... troubleshooting, root cause and failure analysis activity when necessary to resolve the device and reliability failures of RF components. The person should be well… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …Reagent Fill Technician III to support Grifols Diagnostic's Blood Typing Solutions Manufacturing . The Reagent Fill Technician III will be responsible for performing ... manufacturing and assembly of clinical and commercial products. Weighs,...Resource Planning (ERP) System. + Maintains detailed and accurate device history records with cGMP and forwards them in… more
- Teledyne (Camarillo, CA)
- …demonstrate the following qualifications and competencies: + Strong background in semiconductor device design and manufacturing . Experiences in II-VI, III-V or ... development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals… more
- San Jose State University (San Jose, CA)
- …teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and ... and development, biometrics, health economics and outcomes research or manufacturing . + Candidates are expected to teach either full...a minimum of 3-5 years related experience in a medical device , pharmaceutical, In Vitro Diagnostics, and/or… more
- Edwards Lifesciences (Irvine, CA)
- …in engineering or scientific field with at least 4 years of experience in medical device risk management; or Master's degree in engineering or scientific field ... with at least 3 years of experience in medical device risk management. + Strong knowledge of ISO 14971, ISO 13485, 21 CFR Part 820, EU MDR, and FDA… more
- Teleflex (Pleasanton, CA)
- …Mechanical Engineering, Biomedical Engineering or related major) * Minimum 5 years of experience in medical device industry; or at least 3 years of medical ... 10% **Requisition ID** :12317 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health… more