- Gilead Sciences, Inc. (Foster City, CA)
- …for: **Job** **Responsibilities:** * Serve as a lead quality engineer for medical device combination product development projects, with a strong emphasis ... on design control and risk management activities....and experience in quality assurance for the development of medical devices and/or drug- device combination products. **Preferred… more
- Abbott (Santa Clara, CA)
- …providing engineering expertise in its creation and the development of this class 3 medical device product in this desirable technology space. Hiring Manager - ... Technical System Leadership, including driving decision making processes while considering risk management considerations, time criticality, and business needs.… more
- AbbVie (Irvine, CA)
- …but not limited to, medical safety assessments, regulatory responses and risk management plans + Apply current regulatory guidance as appropriate for ... clinical trials and post marketing + Responsible for implementing risk management strategies for assigned products +... Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management , coaching… more
- Abbott (Alameda, CA)
- …and work experience will be accepted. + Related work experience, especially in product Risk Management for medical devices, customer complaints, and product ... the product nonconformances, and including the escalation of higher risk nonconformances to executive management . This position...nonconformances. Prior experience in the medical device industry and/ or quality systems… more
- Terumo Neuro (Aliso Viejo, CA)
- …(SOPs), regulations, standards, good clinical practices, and guidelines applicable to the medical device industry to contribute to overall quality and regulatory ... standards, good clinical practices, and guidelines applicable to the medical device industry. + Identify gaps and...5. Advanced working knowledge of QA principles including Quality Risk Management (QRM), Critical Thinking, and Quality… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …for marketing collateral to support clinical products + Ownership of on-time quality assessments, medical device reporting and health risk assessments to the ... surveillance for BD Biosciences Clinical portfolio of products. Management of these teams requires technical expertise in next...subject matter expertise into design of clinical trials for medical device development and submission to the… more
- Medtronic (Northridge, CA)
- …and project management capabilities. + Experience in designing and developing medical device products + Strong skills in design of experiments, data ... Senior Product Engineer is responsible for leading biological evaluations within a risk management framework, ensuring compliance with ISO 10993 standards and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a working knowledge of human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products. ... communication skills are required. + Demonstrated ability to facilitate the interface with medical device vendors and HF consulting firms. + Demonstrated ability… more
- 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 products. +… more
- Globus Medical, Inc. (Redwood City, CA)
- …3 years with a PhD - related experience with development or verification in the medical device industry. (class III medical device experience preferred). ... At Globus Medical , we move with a sense of urgency...and an understanding of embedded firmware strong desired. + Risk management ( risk analysis, FMEA,… more