Capstan Medical, Inc.

Job Description Job Description Reports to: Head of Software & Controls Workplace Type: Hybrid (onsite in Santa Cruz 3 days/week) At Capstan Medical, we're building one of the most exciting and innovative companies in medtech-developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands-on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone. Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space-creating the perfect place to do meaningful, career-defining work. Overview: Join Us in Revolutionizing Cardiac Care from Beautiful Santa Cruz Imagine leading the verification and validation program for life-saving robotics technology 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 Lead to own the strategy that proves our systems meet the rigorous standards that patient safety demands. You'll be defining and driving verification and validation across our robotic surgical platform, working cross-functionally with systems engineering, software development, quality, and regulatory teams. This is a hands-on leadership role-you'll be writing protocols, executing tests at the bench, and building the V&V program that enables us to bring life-saving technology to patients. 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. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.