- Abbott (Alameda, CA)
- …and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. ... regulations. + Contributes to the planning and execution of risk management for new products and supports...support mobile app deployment activities (for Software as a Medical Device projects). + Drives alignment during… more
- J&J Family of Companies (Irvine, CA)
- …Provide support to Marketing, R&D, Communications, Legal, Quality Assurance/ Risk Management /Product Safety and Commercial teams by providing medical and ... for new products and reviews and approves the final risk management report for all new products...Medical /Clinical/R&D teams in a regulated, commercial biomedical or medical device business is strongly preferred 9.)… more
- Broadcom (San Jose, CA)
- …cellular front-end module development. Part of a global team that develops RF semiconductor device (GaAs HBT, RF SOI, RF CMOS, GaN HEMT) and MMIC (power amplifiers, ... successful candidate will have wide-ranging hands-on experience in RF semiconductor device fabrication and operation, IC foundry process control, MMIC process… more
- Stryker (San Jose, CA)
- …Scientific and medical writing skills. + Knowledge of clinical operations, risk management , regulatory submissions and US and international guidelines. + ... required CERs, and annual updates. + Performs systematic literature reviews for medical device groups or sub-groups. Interprets literature information and… more
- Abbott (Alameda, CA)
- …role will ensure the Medical Events Group (MEG) is compliant with global medical device reporting regulations. This position will be based out of our Abbott ... for identifying any trends that are found during the medical event process and alerting management in...as well as verification of data compiled for metrics, risk evaluations, CAPAs and various other MEG related activities.… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... **Essential Job Functions** + Lead the software development for medical device product(s) in full compliance with...+ Actively participate in Hazard Analysis, Design FMEA, Firmware Risk Assessment, Risk Control measure in a… more
- Edwards Lifesciences (Irvine, CA)
- …portfolio of products across TMTT. The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to ... feedback on moderately complex cross-functional deliverables (eg, clinical study data, risk management documents, IFUs, SSED) using clinical and technical… more
- ZOLL Medical Corporation (San Jose, CA)
- …At least three (3) years of field sales experience - client focus within cardiology, medical device and/or pharma industries required + Five or more years of ... been trusted to protect more than 1M patients at risk of sudden cardiac death. + HFMS (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia- management… more
- Oura (San Francisco, CA)
- …digital health products, including wearable devices and related software, including Software as a Medical Device (SaMD), Software in a Medical Device ... and Good Manufacturing Practices (GMPs), as well as post-market compliance, including Medical Device Reporting (MDR), product recalls, corrective actions, and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class II or III devices, or ... as required + Expert knowledge of design controls and risk management + Experience in front room...(Design Assurance, Quality Operations, etc.) + Experience in full Medical Device product lifecycle. Ie Demonstrated … more