Senior Verification & Validation Engineer

Capstan Medical·
Santa Cruz, CA (Hybrid)
2w ago
Full-timeMidEngineeringRoboticsUnknownBachelors
Market Rate — Chemical Engineers
25th
$92K
Median
$112K
75th
$139K

BLS 2024 data (national)

Description

Join Us in Revolutionizing Cardiac Care from Beautiful Santa Cruz. Imagine ensuring life-saving robotics technology works flawlessly while being minutes from world-class surf breaks and redwood forests. We’re developing a groundbreaking robotic platform that gives surgeons superhuman precision in transcatheter valve deployment—and we need an exceptional V&V Engineer to help us prove our systems meet the rigorous standards that patient safety demands. You’ll be designing and executing verification and validation strategies for complex robotic software and systems, working at the intersection of rigorous testing methodologies, regulatory compliance, and life-critical medical devices. What You’ll Do: - Design, develop, and execute software verification test protocols that demonstrate compliance with system and software requirements per IEC 62304 - Create and maintain requirements traceability matrices linking User Needs through system requirements, software requirements, and verification evidence - Develop test strategies spanning unit, integration, and system-level verification for real-time robotic control software - Execute design validation activities including bench testing, simulated use testing, and support of clinical evaluations - Author clear, detailed test protocols and reports that withstand regulatory scrutiny from FDA and notified body reviewers - Collaborate with systems engineering to ensure software requirements are testable, complete, and properly decomposed from user needs - Support risk management activities by ensuring verification activities adequately address software safety classification per IEC 62304 Class B/C requirements - Identify gaps in test coverage and drive continuous improvement of V&V processes and infrastructure - Work with software developers to establish automated test frameworks that integrate with CI/CD pipelines while maintaining design control compliance - Support design reviews, providing V&V perspective on requirement clarity, testability, and verification approach

Requirements

Experience & Background: - BS in Computer Science, Software Engineering, Biomedical Engineering, or equivalent - 3-5 years of experience in software V&V, test engineering, or software quality in the medical device industry - Track record of delivering verification evidence packages for regulatory submissions - Experience navigating ambiguity while maintaining compliance rigor - Understanding of the complete design control process from user needs through design transfer - Ability to work in a hybrid environment, onsite 3 days a week at our Santa Cruz, CA office. In the future, there will be an option to work one day from our satellite office in Los Altos, CA.
Capstan Medical

Capstan Medical

BIOTECHNOLOGY

Heart Valve Replacement

LocationCA - Santa Cruz
Open Jobs21
CardiovascularMetabolic Diseases
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