- Stryker (Irvine, CA)
- …**Preferred:** + MS, CQE, or CRE. + Six Sigma Green or Black belt. + Medical device industry experience is strongly preferred. + Experience in interacting with ... performance across the business and for customers while ensuring regulatory standards and compliance. **What You Will Do:** +...MoH, TUV, etc.). + Understanding of US and International Medical Device Regulations. + Familiarity with ISO… more
- Gilead Sciences, Inc. (Foster City, CA)
- …review/approve Gilead and CMO APQRs for commercial products. + Accountable for medical device / combination product quality compliance: engage/liaise with ... Biological Product Deviation and Complaints. + Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist...medical device product engineering, development, and quality teams. + Facilitate… more
- Terumo Neuro (Aliso Viejo, CA)
- …review, investigation, and assessment of adverse events. 5. Class III medical device safety experience. **External-Facing Title:** Specialist, Clinical Safety ... milestones and to provide regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical expertise to provide input… more
- TEKsystems (San Diego, CA)
- Job Posting: Test Engineer II - Advanced Medical Device Testing Location: San Diego, CA Industry: Medical Technology / Device Engineering Overview: Join ... a dynamic and innovative team at the forefront of medical device development. We're seeking a Test...validate robust, scalable test methods aligned with product and regulatory requirements. + Troubleshoot and optimize test setups using… more
- Abbott (Alameda, CA)
- …in model based design (UML or SysML), is highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Abbott (Sylmar, CA)
- …diverse and growing portfolio of digital health products, including software as a medical device (SaMD), connected devices, and digital health platforms. This ... field + Minimum 12 years of proven experience in Connectivity development within the medical device / life sciences / digital health space, 5+ years being… more
- GRAIL (Menlo Park, CA)
- …experience in managing clinical trials at a sponsor company (pharma, biotech, or medical device ) with a strong track record of successful trial initiation ... experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable + Thorough knowledge of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …ISO 13485. IEC 60601 and IEC 62304 experience a plus. + Experience in medical device and/or regulated industry (required). + Experience with remediation efforts ... Experience:** + 8+ years in a regulated industry, particularly within the medical device , bio-pharmaceutical, or biotechnology sectors, with a strong preference… more
- Abbott (San Diego, CA)
- …Computer Science, or related field. + 6+ years of experience in embedded systems, medical device development, or product cybersecurity. + 10 years of general ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Abbott (Sylmar, CA)
- …diverse and growing portfolio of digital health products, including software as a medical device (SaMD), connected devices, and digital health platforms. This ... preferred) + 10+ years of progressive experience in Quality Assurance within the medical device or digital health industry + Deep knowledge of global… more