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Capstan Medical

Robot type
Surgical and Medical
Location
Santa CruzCaliforniaUSA
Job type
Software
Posted
Feb 12, 2026
Full-time

Verification & Validation Lead

Job description

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…

Job requirements

  • 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

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