- J&J Family of Companies (Santa Clara, CA)
- …PhD is a strong plus. + Minimum of 15 years' progressive experience in medical device development , including 5+ years' experience in leading projects ... Strong background in acoustics and/or ultrasound sensors + Experience with disposable medical device development , preferably coronary and/or vascular… more
- J&J Family of Companies (Irvine, CA)
- …leading Medical /Clinical/R&D teams in a regulated, commercial biomedical or medical device business is strongly preferred 9.) Demonstrated success in ... providing therapeutic and clinical expertise in support of the development of medical devices for the treatment...Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If… more
- Amazon (Sunnyvale, CA)
- Description Our team leads the development and optimization of on- device ML models for Amazon's hardware products, including audio, vision, and multi-modal AI ... resource-constrained devices. Currently, we enable production ML models across multiple device families, including Echo, Ring/Blink, and other consumer devices. Our… 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 ... laws, regulations, standards, good clinical practices, and guidelines applicable to the medical device industry. + Identify gaps and develop and/or standardize… more
- GRAIL (Menlo Park, CA)
- …+ Demonstrated knowledge of US and international regulatory frameworks and processes for medical device development and approvals. + Effective collaborator ... . The role assists with regulatory strategy and the development of submissions in partnership with key internal and...clinical affairs, quality, or program management within the IVD, medical device , or pharmaceutical industries. + Regulatory… more
- Amazon (Sunnyvale, CA)
- …Ring, and Kuiper. They collaborate with Program Managers, Contract Manufacturers, and development teams to plan, allocate and process thousands of prototype ... Description Amazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer...and Astro. What will you help us create? The Device Services Tracking Team (DSTT) is responsible for managing,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …expertise in applying FDA design control requirements (21 CFR ) as applied to medical device software and medical device regulation (IEC-62304) ... Engineer to join our growing team and lead the development and strategy for our Digital Medicine Platform's service...CI/CD for AWS serverless deployments + PHI/PII and/or Med device or other device -related experience + Demonstrated… more
- Abbott (Milpitas, CA)
- …in model based design (UML or SysML), is highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory ... required + Excellent troubleshooting skills + Knowledgeable of device driver and low-level device interface design and development is required + Experience… more
- Edwards Lifesciences (Sacramento, CA)
- …+ Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research ... and physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device accountability and… more
- Abbott (Alameda, CA)
- …Excellent knowledge of general Engineering principles. + Extensive Knowledge of regulations for medical device development (ISO13485, FDA) is a plus. ... a development environment with an emphasis on medical product development . + Writing process...+ Extensive knowledge and understanding of GxP, ISO and medical device regulations and the development… more