- Gilead Sciences, Inc. (Foster City, CA)
- …projects, with a strong emphasis on design control and risk management activities. + Collaborate with device engineering on new combination product ... for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments. + Develop...and experience in quality assurance for the development of medical devices and/or drug- device combination… more
- J&J Family of Companies (Irvine, CA)
- …recruiting for a Director, Product Security within our Information Security and Risk Management (ISRM) organization. The preferred locations for this hybrid ... logging, and secure communications (eg TLS/mTLS). + Oversee security integration across medical devices , software, mobile applications, embedded devices , and… more
- Oura (San Francisco, CA)
- …health products, including wearable devices and related software, including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), ... and Good Manufacturing Practices (GMPs), as well as post-market compliance, including Medical Device Reporting (MDR), product recalls, corrective actions, and… more
- Abbott (Santa Clara, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... providing engineering expertise in its creation and the development of this class 3 medical device product in this desirable technology space. Hiring Manager -… more
- Abbott (Sylmar, CA)
- …and improve chronic disease management . Together with Abbott's life-changing medical devices , Digital Solutions leverages technologies such as AI and ... portfolio of digital health products, including software as a medical device (SaMD), connected devices ,...strategy + Provide strategic input into AI product development, risk management , and lifecycle planning + Partner… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …program. + Experience working in a design center. **Knowledge and Skills:** + Quality Management Systems requirements for medical devices + Knowledge and ... Center. + Collaborates with core teams to establish Design Controls and Risk Management implementation strategies in compliance with internal, Industry, and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … management processes (ISO 14971) and cybersecurity considerations for medical devices . + Exceptional analytical and problem-solving skills. + Excellent ... Staff Specialist Regulatory Affairs, you will have a deep understanding of Risk Based frameworks, Agile SDLC, experience with cross functional team transactions, and… more
- Sodexo (Los Angeles, CA)
- …and security guidelines for medical devices . + Conduct technical risk assessments and determine device exposure based on vulnerabilities. + Manage both ... asset management best practices. + Experience with medical device configuration, vulnerability patching, and ...risk assessments. + Specific experience with the following medical devices or equipment: DiCom, Siemens, Toshiba,… more
- Stryker (San Jose, CA)
- …Scientific and medical writing skills. + Knowledge of clinical operations, risk management , regulatory submissions and US and international guidelines. + ... Reports (CERs) and post market clinical follow-up (PMCF) documents for new medical devices to support product registrations internationally, maintain periodic… more
- Abbott (Sylmar, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... staff in the company. + Gathers and analyzes input requirements for medical devices , supporting instrumentation/service infrastructure, and translates these into… more