- Oura (San Francisco, CA)
- …management of a quality system, including external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. ... tracking. We view Oura Ring as a clinical grade device in a consumer package rather than as a...do: + Lead regulatory and quality strategy for product development , approval, and lifecycle management for all regulated features.… more
- Otsuka America Pharmaceutical Inc. (Palo Alto, CA)
- …Advanced degree (MD, DVM, PhD) with 1-3 years of relevant experience. * Prior medical device or cardiovascular device industry, preferred. * Prior experience ... **Position Summary:** The Staff, Preclinical Scientist will join the Medical Affairs Team with the responsibilities of supporting the design, conduct, and analysis… more
- Terumo Neuro (Aliso Viejo, CA)
- …and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4. Proven experience in statistical analysis ... Focus Lead quality engineering projects to support the development of medical devices. Work with Manufacturing...design verification, and design validation. 2. Strong knowledge of medical device design control process. 3. Ability… more
- Palo Alto Networks (Santa Clara, CA)
- …ability to architect scalable and maintainable test frameworks + Solid understanding of software development best practices, including the use of version control ... each employee as a unique individual. Knowing we all have different needs, our development and personal wellbeing programs are designed to give you choice in how you… more
- Insight Global (Irvine, CA)
- …experience with ML frameworks Bachelor's Degree Familiarity with FDA-regulated environments or medical device development . Experience in biomedical signal ... Job Description A large medical device company in Irvine, CA...is passionate about developing algorithms that drive innovation in medical technology. Key Responsibilities Algorithm Development : Translate… more
- Ford Motor Company (Palo Alto, CA)
- …electrical, mechanical, and software domains * Strong comprehension of embedded software development languages (C/C++) * Experience with Python is desired * ... will be responsible for Heating, Ventilation and Air Conditioning (HVAC) sub system device and feature development . This individual would ensure HVAC hardware… more
- J&J Family of Companies (Santa Clara, CA)
- …a sharp strategic mind pulled from insights within J&J as well as the medical device industry and more broadly, excellent written and oral communications, and ... Pricing for Robotics and Digital Solutions will support the development and execution of pricing strategy throughout the entire... as a service (SaaS) + Experience in the medical device industry and product/market knowledge of… more
- Abbott (Alameda, CA)
- …medical devices, customer complaints, and product nonconformances. Prior experience in the medical device industry and/ or quality systems are required. + ... full life. You'll also have access to: + Career development with an international company where you can grow...FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO14971, as… more
- US Tech Solutions (Thousand Oaks, CA)
- …+ Experience with combination products and device regulatory requirements and medical device development and engineering **Preferred Traits:** + Passion ... in Computer Science, Electrical Engineering, or Computer Engineering, or those with purely software -focused backgrounds, are not a fit for this role. + The Digital… more
- Legrand NA (Carlsbad, CA)
- …design, and implementation. The candidate may participate in any part of the Software Development Lifecycle. This role will support the Lighting Management ... of a design team, develops, evaluates, and verifies system- and device -level requirements, architecture, and interface specifications; device -level firmware… more