Senior Sustaining Engineer
$125,000–$1,250,000 year
On-site · Santa Clara, California, United States
Job Summary
Senior Sustaining Engineer responsible for lifecycle support of commercially released MONARCH platform medical device instruments and capital equipment within the MedTech Surgery group. Leads root cause investigations for field issues, coordinates design updates and process improvements, manages documentation (test protocols/reports, engineering studies, drawings, design history files), and ensures safety, performance, and regulatory compliance across the product lifecycle. Works cross-functionally with Instruments & Accessories, Vision, Mechanical, Electrical, Software, and Systems Engineering, QA, Manufacturing, Service, and Regulatory Affairs to maintain device reliability and support external manufacturing transfers and EOL activities. Requires Bachelor's degree in Engineering or related field, 4+ years in sustaining/product lifecycle roles, and strong CAD and risk-management capabilities.
Required Qualifications
- Bachelor’s Degree in Engineering or related field
- Minimum of 4+ years of sustaining engineering, product lifecycle support, or related engineering roles within a regulated industry
- Strong experience in Design Control and cross-functional teamwork
- Experience designing and building test equipment and fixtures
- Knowledge of mechanical design, mechatronics, sensors, electronics and software management
- Proficiency in CAD software (e.g., SolidWorks)
- Experience with risk assessments and regulatory compliance in medical devices
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