Capstan Medical, Inc. - Verification & Validation Lead

• Deep expertise in IEC 62304 software lifecycle processes, safety classification, and verification requirements • Strong understanding of ISO 14971 and IEC 60601 risk management principles and how verification addresses risk controls • Proven ability to develop V&V strategies and plans for complex medical device programs • Experience managing V&V timelines, resources, and deliverables across multiple concurrent workstreams • Proficiency in requirements management and traceability tools (e.g., Jama, DOORS, Polarion, or similar) • Excellent technical writing skills—you can author and review audit-ready documentation • Strong communication and influencing skills—you can drive alignment across engineering, quality, and regulatory stakeholders • Understanding of the complete design control process from user needs through design transfer and post-market surveillance • Experience with robotic systems, motion control, or real-time embedded software testing • Experience building or scaling V&V functions in a startup or growth-stage environment • Experience with test automation frameworks and scripting (Python preferred) • Experience with test fixtures, hardware-in-the-loop testing, or bench test development • Knowledge of FDA 21 CFR 820, ISO 13485, and EU MDR requirements • Track record of successful FDA 510(k), De Novo, or PMA submissions • Exposure to usability engineering (IEC 62366) and design validation methodologies • BS in Computer Science, Software Engineering, Biomedical Engineering, or equivalent; MS preferred • 5-10 years of experience in software V&V, test engineering, or software quality in the medical device industry • Demonstrated leadership experience—formal or informal—in guiding V&V activities and mentoring engineers • Comfortable being hands-on: you’re energized by executing tests yourself, not just delegating • Track record of delivering verification evidence packages for regulatory submissions • Experience working cross-functionally to influence requirements, risk management, and design decisions • 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.