Capstan Medical · 4 days ago
Senior Verification & Validation Engineer
Santa Cruz County, CA
Full-time
Hybrid
Mid, Senior Level
3+ years expCapstan Medical is focused on revolutionizing cardiac care through innovative robotic technology. They are seeking a Senior Verification & Validation Engineer to design and execute verification and validation strategies for complex robotic software and systems, ensuring compliance with rigorous safety standards.
MedicalMedical DeviceRobotics
Responsibilities
Design, develop, and execute software verification test protocols that demonstrate compliance with system and software requirements per IEC 62304
Create and maintain requirements traceability matrices linking User Needs through system requirements, software requirements, and verification evidence
Develop test strategies spanning unit, integration, and system-level verification for real-time robotic control software
Execute design validation activities including bench testing, simulated use testing, and support of clinical evaluations
Author clear, detailed test protocols and reports that withstand regulatory scrutiny from FDA and notified body reviewers
Collaborate with systems engineering to ensure software requirements are testable, complete, and properly decomposed from user needs
Support risk management activities by ensuring verification activities adequately address software safety classification per IEC 62304 Class B/C requirements
Identify gaps in test coverage and drive continuous improvement of V&V processes and infrastructure
Work with software developers to establish automated test frameworks that integrate with CI/CD pipelines while maintaining design control compliance
Support design reviews, providing V&V perspective on requirement clarity, testability, and verification approach
Qualification
Required
Design, develop, and execute software verification test protocols that demonstrate compliance with system and software requirements per IEC 62304
Create and maintain requirements traceability matrices linking User Needs through system requirements, software requirements, and verification evidence
Develop test strategies spanning unit, integration, and system-level verification for real-time robotic control software
Execute design validation activities including bench testing, simulated use testing, and support of clinical evaluations
Author clear, detailed test protocols and reports that withstand regulatory scrutiny from FDA and notified body reviewers
Collaborate with systems engineering to ensure software requirements are testable, complete, and properly decomposed from user needs
Support risk management activities by ensuring verification activities adequately address software safety classification per IEC 62304 Class B/C requirements
Identify gaps in test coverage and drive continuous improvement of V&V processes and infrastructure
Work with software developers to establish automated test frameworks that integrate with CI/CD pipelines while maintaining design control compliance
Support design reviews, providing V&V perspective on requirement clarity, testability, and verification approach
Strong understanding of IEC 62304 software lifecycle processes and safety classification
Experience writing and executing verification protocols for medical device software
Proficiency in requirements management and traceability tools (e.g., Jama, DOORS, Polarion, or similar)
Understanding of ISO 14971 and IEC 60601 risk management principles and how verification addresses risk controls
Familiarity with software testing methodologies: unit testing, integration testing, system testing, regression testing
Strong technical writing skills—you can translate complex test results into clear, audit-ready documentation
Debugging skills to isolate and characterize software defects with reproducible steps
BS in Computer Science, Software Engineering, Biomedical Engineering, or equivalent
3-5 years of experience in software V&V, test engineering, or software quality in the medical device industry
Track record of delivering verification evidence packages for regulatory submissions
Experience navigating ambiguity while maintaining compliance rigor
Understanding of the complete design control process from user needs through design transfer
Ability to work in a hybrid environment, onsite 3 days a week at our Santa Cruz, CA office
Preferred
Experience with robotic systems, motion control, or real-time embedded software testing
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
Experience supporting FDA 510(k) or De Novo submissions
Exposure to usability engineering (IEC 62366) and design validation methodologies
Company
Capstan Medical
Capstan Medical is creating minimally invasive technologies to treat heart valve disorders.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$141.4MKey Investors
Eclipse Ventures
2024-12-11Series C· $110M
2023-08-09Series B· $31.4M
Leadership Team
Dan Wallace
Founder & CTO at Capstan Medical
Recent News
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