- J&J Family of Companies (Santa Clara, CA)
- …portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary ... **Essential Job Functions** + Lead the software development for medical device product(s) in full compliance with the company's Design Control requirements… more
- Abbott (Alameda, CA)
- …preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. **What You'll ... product design projects to ensure compliance with the internal design control process and external standards and regulations. + Contributes to the planning and… more
- Amazon (Sunnyvale, CA)
- …Amazon seeks an experienced Senior Finance Analyst to play a role on our Device Logistics Finance Team. This role can be based in Amazon offices in: Sunnyvale, ... CA Key job responsibilities Partner directly with our Device Finance team to drive visibility and sound decision...workplace accommodation or adjustment during the application and hiring process , including support for the interview or onboarding … more
- Skyworks (Irvine, CA)
- …communicates. Requisition ID: 74982 Description Skyworks Solutions seeks a director of BAW device development who will lead a small but highly skilled team in the ... BAW, and other MEMs technologies primarily working at the device level. Work closely with a technical team to:...understanding of Bulk Acoustic Wave (BAW) devices and associated process technology. + Experienced in using Finite Element Modeling… more
- Terumo Neuro (Aliso Viejo, CA)
- …standards, good clinical practices, and guidelines applicable to the medical device industry to contribute to overall quality and regulatory compliance objectives. ... responsibilities including conducting clinical research audits (sponsor, site, vendor, process , function, and systems); preparing for and hosting external regulatory… more
- J&J Family of Companies (Santa Clara, CA)
- …specifications, design for quality and manufacturing requirements, process /technology development, product verification/validation, manufacturing, supplier controls, ... investigations involving medical devices. + Partner with Operations and Process Excellence to set strategies that drive continuous improvements...industry with at least 12 years in a medical device industry. + A minimum of 10 years is… more
- GRAIL (Menlo Park, CA)
- …position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual ... 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings. + Serve as a key member of the Regulatory… more
- Medtronic (Irvine, CA)
- …following and other duties may be assigned: + Represents Medtronic as device specialist during surgical procedures by ensuring all necessary equipment and products ... required are available, providing technical support and device selection, and performing programming and testing of...+ Manages patients through all phases of the clinical process as well as educate them on the features… more
- Edwards Lifesciences (Sacramento, CA)
- …and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, ... Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements. + Contribute to the development of clinical… more
- AbbVie (Irvine, CA)
- …product, process , equipment, and facilities of pharmaceutical, biological or device related products. + Knowledge of QA systems and GMP compliance requirements ... Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position...and CAPA. This position will ensure that all product, process or system related quality activities from raw material… more