Medical Robotics V&V Engineer — Hybrid (Santa Cruz)

Capstan Medical Inc.; Santa Cruz (CA); Hybrid; USD 90,000 - 140,000; Full time

Job summary

Capstan Medical Inc. is seeking a skilled V&V Engineer to verify and validate our groundbreaking robotic software and systems for cardiac care.

You will design verification strategies, ensure traceability from user needs to verification evidence, and support regulatory submissions with robust, audit-ready documentation. You will work across unit, integration, and system testing, perform design validation activities, and collaborate with systems engineering to ensure requirements are testable and

Qualifications

• BS in Computer Science, Software Engineering, Biomedical Engineering, or equivalent.
• 3–5 years of software V&V, test engineering, or software quality in medical device industry.
• Track record delivering verification evidence packages for regulatory submissions.
• Experience navigating ambiguity while maintaining compliance rigor.
• Understanding of complete design control from user needs to design transfer.
• Hybrid onsite 3 days/week at Santa Cruz, CA; future satellite office option in Los Altos, CA.

Responsibilities

• Design, develop, and execute software verification protocols to demonstrate compliance with IEC 62304.
• Create and maintain requirements traceability matrices from User Needs to verification evidence.
• Develop test strategies for unit, integration, and system-level verification of real-time robotic control software.
• Conduct design validation activities including bench testing and simulated use; support clinical evaluations.
• Author clear test protocols and reports for FDA and notified body review.

Skills

IEC 62304

Verification protocols

Regulatory documentation

Requirements traceability

Testing methodologies

Technical writing

Debugging

Education

BS in Computer Science, Software Engineering, Biomedical Engineering, or equivalent

Tools

Jama

DOORS

Polarion

Job description

Capstan Medical Inc. is seeking a skilled V&V Engineer to verify and validate our groundbreaking robotic software and systems for cardiac care.

You will design verification strategies, ensure traceability from user needs to verification evidence, and support regulatory submissions with robust, audit-ready documentation. You will work across unit, integration, and system testing, perform design validation activities, and collaborate with systems engineering to ensure requirements are testable and