Capstan Medical, Inc.
Verification & Validation Lead
Santa Cruz, California
Sponsorship not specifiedDetected 160 days ago
Systems EngineeringRoboticsMedical DevicesLeadershipCommunicationCollaborationMentoringWriting
About the role
- 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.
- 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.
Requirements
- Track record of delivering verification evidence packages for regulatory submissions
Nice to have
- BS in Computer Science, Software Engineering, Biomedical Engineering, or equivalent
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
- 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
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