Verification & Validation Lead

Leadership & Strategy

• Own the V&V strategy for the robotic surgical platform, defining the approach for software, system, and design validation activities
• Plan and manage V&V project timelines, resource allocation, and deliverables aligned with program milestones and regulatory submissions
• Establish and continuously improve V&V processes, templates, and infrastructure to scale with the organization
• Mentor and guide V&V engineers, fostering technical growth and maintaining high standards for verification evidence

Cross-Functional Collaboration

• Partner with systems engineering to influence system requirements, ensuring they are verifiable, traceable, and properly decomposed from user needs
• Collaborate with regulatory affairs to shape submission strategy and ensure V&V deliverables meet FDA and notified body expectations
• Work with risk management to ensure verification activities adequately address risk controls and software safety classification per IEC 62304 and ISO 14971
• Engage with clinical and human factors teams to plan and execute design validation activities including simulated use and clinical evaluations
• Represent V&V in design reviews, providing expert input on requirement clarity, testability, and verification approach

Technical Execution

• Design and execute software verification test protocols demonstrating compliance with system and software requirements per IEC 62304
• Personally execute test cases at the bench—we don’t have a separate test execution team, and all engineers participate in running DV protocols
• Own requirements traceability matrices linking User Needs through system requirements, software requirements, and verification evidence
• Develop and execute test strategies spanning unit, integration, and system-level verification for real-time robotic control software
• Author and review test protocols and reports that withstand regulatory scrutiny from FDA and notified body reviewers
• Drive adoption of automated test frameworks that integrate with CI/CD pipelines while maintaining design control compliance

Skills:

• 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

Preferred:

• 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

Requirements:

• 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.