Senior Verification & Validation Engineer

Capstan Medical Inc.; Santa Cruz (CA); Ibrido; USD 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

IEC 62304

Verification protocols

Regulatory documentation

Requirements traceability

Testing methodologies

Technical writing

Debugging

Formazione

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

Strumenti

Jama

DOORS

Polarion

Descrizione del lavoro

Overview:

Join Us in Revolutionizing Cardiac Care from Beautiful Santa Cruz

Imagine ensuring life-saving robotics technology works flawlessly 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 Engineer to help us prove our systems meet the rigorous standards that patient safety demands.

You’ll be designing and executing verification and validation strategies for complex robotic software and systems, working at the intersection of rigorous testing methodologies, regulatory compliance, and life-critical medical devices. This isn’t just another test engineering job—you’re building the evidence that our technology is ready to save lives.

What You’ll Do:

• 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

Skills:

• 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

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

Requirements:

Experience & Background

• 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. 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.