- J&J Family of Companies (Irvine, CA)
- …impact health for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Product Development **Job Sub** **Function:** Multi-Family R&D Product ... Electrophysiology field is highly preferred + Knowledge or experience in electromagnetically navigated device development is a plus + The ability to interpret an… more
- Abbott (Alameda, CA)
- …discipline. + Must have 5+ experience in Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- J&J Family of Companies (Irvine, CA)
- … adoption and lifecycle management, and work closely with the R&D teams during product development and with marketing and commercial teams during product ... to influence overall regulatory and commercial strategy, as well as support product development , pre- and post-approval clinical studies, downstream claims,… more
- Cordis (Irvine, CA)
- …provide key clinical and scientific insights to internal stakeholders-such as Clinical Development , Medical Affairs, and Commercial teams, helping shape strategy ... heart of innovation to transform cardiovascular care. Our flagship product , SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing… more
- Skyworks (Irvine, CA)
- …into to BAW Filter New Product Introduction (NPI) organization to lead our product development teams. Reporting directly to the BAW Filter New Product ... engineering communication system on BAW stacks for shortening our product development cycle. * Collaborate and openly...from industry and university experience in BAW/SAW and/or MEMS device development including device structure… more
- Hologic (San Diego, CA)
- … product /process development /transfer experience in a regulated environment ( Medical Device or Pharmaceutical) **Required Skills** + Knowledge of GMP/GLP ... resolution to investigations resulting from non-conformances; and + Participate in new product development , scale-up and optimization projects and core teams.… more
- Abbott (Alameda, CA)
- … is required. **Preferred Qualifications** + Solid knowledge of regulations for medical device development , (EN460001, ISO13485, FDA) is desirable. ... device preferred + Embedded UI design experience preferred + Detailed experience with medical device development processes and FDA 510K and PMA regulatory… more
- Astellas Pharma (South San Francisco, CA)
- …evaluate and develop suitable formulations and manufacturing processes for rAAV drug product under development , supporting the growing and diversifying portfolio ... world. We are committed to turning innovative science into medical solutions that bring value and hope to patients...+ Experience with preparation activities for PPQ of drug product manufacturing processes. + Experience in the development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Lead or support human factors engineering (HFE) strategies and HFE activities for device combination product design and development from feasibility, ... color theory. + Experience with leading HFE efforts in support of combination product development and commercialization, including a working knowledge of human… more
- Stryker (San Jose, CA)
- …Assurance** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) ... a software design quality assurance engineer for pre-market new product development projects. **Workplace Flexibility & Location...4 years of professional experience in the highly regulated medical device industry, with a focus in… more