- Gilead Sciences, Inc. (Foster City, CA)
- …**Key** **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. + Collaborate with device engineering on new combination product development, supporting design verification, validation, and… more
- Terumo Neuro (Aliso Viejo, CA)
- …2. Minimum five (5) years of relevant experience in product labeling in medical device field. 3. Minimum one (1) year of experience in project management in a ... (eg 21 CFR 801 - Labeling, 21 CFR 820 - Device Labeling, 21 CFR 830 - Unique Device Identification, FDA 89-4203, ISO 15223, CDRH Guidance Document, etc.). 6.… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …and other departments/business units for complaint investigations + Evaluate complaints for Medical Device Reporting (MDR) + Prepare and submit MDR reports to FDA + ... related field, 2-5 years experience complaint handling Required andmedical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare,… more
- IQVIA (San Diego, CA)
- …healthcare professionals and advocate for the well-being of patients through medical device technology. You will be responsible for training and educating Registered ... in-servicing to nurses, physicians, and hospital staff to support medical device implementations Assess customer-specific education needs and collaborate with staff… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …CI/CD with focus on CI/CD for AWS serverless deployments + PHI/PII and/or Med device or other device -related experience + Demonstrated expertise in applying FDA ... design control requirements (21 CFR ) as applied to medical device software and medical device regulation (IEC-62304) **Competencies** **Accountability for… more
- Skyworks (Irvine, CA)
- …the technology development of piezoelectric bulk acoustic resonators (BAW) including device modeling, characterization and EDA support. It is a cross-functional role ... Construct FEM and circuit models in collaboration with other device modeling and circuit design engineers + Analyze on-wafer... modeling and circuit design engineers + Analyze on-wafer device statistics of key device parameters +… more
- Abbott (Menlo Park, CA)
- …restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the ... + Minimum of 5 years' experience of Risk Management in the Medical Device or Pharmaceutical Industry, preferably focused on complaint management and Health Hazard… more
- J&J Family of Companies (Santa Clara, CA)
- …quality management systems in regulated industry with at least 12 years in a medical device industry. + A minimum of 10 years is required as a quality leader, ... and Development including End-to-End Quality & Compliance in Medical Device . + Must have a minimum of 5 years...a minimum of 5 years of large-scale Capital Medical Device Equipment experience as a quality leader with a… more
- Medtronic (Irvine, CA)
- …support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; ... analysis of customer returns; supplier related engineering changes and optimizing device production relative to cost constraints. + Assumes responsibility for … more
- Meta (Burlingame, CA)
- …Reality Labs at Meta is seeking Research Engineers to develop and enhance on- device AI/ML models for our Wearables devices. This role is pivotal in advancing ... Wearables AI Responsibilities: 1. Lead the design, development, and optimization of on- device AI models for gesture recognition 2. Adapt standard machine learning… more