Staff R&D Engineer
$160,000–$185,000 year
On-site · Campbell, California, United States
Job Summary
Lead technical design and development of endovascular/neurovascular medical devices from early prototyping to manufacturing transfer; mentor junior R&D engineers; drive innovation while ensuring manufacturability and cost targets; collaborate with customers, marketing, physicians, pre-clinical engineering, and regulatory affairs to translate user needs into comprehensive product requirements; conduct animal, cadaver, and bench studies to evaluate performance and usability; lead design-focused risk analysis, verification/validation planning, and test development; evaluate new vendors/materials/processes; guide cross-functional teams to ensure product development complies with customer needs, quality systems, budgets, schedules, and regulatory requirements; ensure proper documentation and enable manufacturing transfer; familiarity with PLM and regulatory environments (FDA, GMP, QSR, ISO 13485/9001, MDD); proficiency with CAD tools (SolidWorks, Pro/E) and statistical software (Minitab); strong communication and documentation skills, with experience leading technical teams in regulated medical device development.
Required Qualifications
- Bachelor’s degree in engineering, or related discipline
- minimum of 8 years of related experience developing flexible medical device instruments
- MS in Engineering and experience in medical device development in a start-up environment preferred
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