- Medtronic (Santa Rosa, CA)
- …development life cycle. + In depth experience supporting successful software device development (SaMD, AI, Cybersecurity, IEC 62304/82304) and associated ... CA. The **Principal Regulatory Affairs Specialist** will support Research and Development programs with early phase pre-market regulatory strategy development … more
- Abbott (Alameda, CA)
- …based design (UML or SysML), is highly desirable + Detailed experience with medical device development processes and FDA 510K and PMA regulatory requirement + ... skills + Knowledgeable of device driver and low-level device interface design and development is required + Familiarity with signal and data processing… more
- AbbVie (Irvine, CA)
- …products to patients. Supports regulatory objectives for the company's development and marketed device /combination products including coordination, management ... DE NOVO, post-approval reports, annual reports, export certificates, establishment registrations and device listings. Support the development of the device … more
- Abbott (Milpitas, CA)
- …usability and validation testing. + Extensive knowledge of entire medical device development process from needs definition through regulatory approvals, ... degree in one of the above disciplines. + Experience in medical device development especially in system engineering and/or risk management + Working knowledge of… more
- Abbott (Alameda, CA)
- …of general Engineering principles. + Extensive Knowledge of regulations for medical device development (ISO13485, FDA) is a plus. Extensive understanding of ... products. + Extensive knowledge and understanding of GxP, ISO and medical device regulations and the development /implementation of new products/processes in a… more
- AbbVie (Pleasanton, CA)
- …education and experience, position requires: Six (6) years of experience with medical device development life cycles and Design Control processes; Six (6) years ... Responsible for Quality Engineering deliverables required within the product development process. + Support Design Verification and Validation activities, including… more
- Terumo Neuro (Aliso Viejo, CA)
- …products, hardware, software, and methodologies. 9. Experienced in supporting medical device development through various advanced engineering and analytical ... Support development of products and/or product engineering for medical device with work including writing or verifying specifications; designing new products and… more
- Medtronic (Irvine, CA)
- …patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development -we actively collaborate with the medical community to ... plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy,… more
- Amazon (Pasadena, CA)
- …our device lifecycle workflow About the team You will be joining the Device Lifecycle software development team within the AWS Center of Quantum Computing. ... The AWS Center for Quantum Computing (CQC) is seeking a Sr. Software Development Engineer to lead the technical direction of our software team responsible for… more
- Meta (Burlingame, CA)
- …Phones via Wireless technology 20. 10. Working on frameworks for Wireless device development . **Public Compensation:** $225,569/year to $240,240/year + bonus + ... processing and machine learning. 4. Create and maintain system software components including device drivers, firmware and tools to manage the hardware. 5. Work with… more