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Verification And Validation information

What are the key skills and qualifications needed to thrive in verification and validation?

To excel in Verification and Validation, you typically need a background in engineering or computer science, strong analytical skills, and an understanding of industry standards. Familiarity with test management tools, automation frameworks, and quality assurance methodologies, as well as relevant certifications like ISTQB, is highly valuable. Attention to detail, problem-solving abilities, and strong communication are crucial soft skills for this role. These competencies ensure that products meet requirements, function reliably, and minimize defects before release.

What is the difference between Verification And Validation vs Quality Assurance?

AspectVerification And ValidationQuality Assurance
FocusEnsuring products meet specifications and are fit for purposePreventing defects through process improvements
ActivitiesReviews, testing, validation protocolsProcess audits, standards compliance, process improvements
TimingDuring and after developmentThroughout the development process
CertificationsOften requires technical testing certificationsQuality management system certifications (e.g., ISO 9001)

Verification and Validation focus on confirming that a product meets requirements and is fit for use, primarily through testing and reviews. Quality Assurance emphasizes establishing processes to prevent defects, ensuring consistent quality throughout development. Both are essential but serve different roles in maintaining product quality.

What are some common challenges faced in a verification and validation role, and how can they be addressed?

A common challenge in Verification and Validation roles is keeping up with rapidly changing project requirements and ensuring tests remain relevant and comprehensive. Additionally, V&V professionals often need to collaborate closely with both development and quality assurance teams, which requires strong communication and documentation skills. Addressing these challenges involves adopting agile methodologies, maintaining clear and regular communication channels, and continuously updating test plans and documentation to reflect the latest system changes.

What is verification and validation?

Verification and Validation (V&V) are two key processes used to ensure that a product, system, or software meets its requirements and works as intended. Verification involves checking that the product is built correctly according to specifications, typically through reviews, inspections, and testing during development. Validation, on the other hand, confirms that the final product fulfills its intended purpose and meets the needs of users or stakeholders. Together, V&V help ensure quality, safety, and compliance in various industries such as software, aerospace, and manufacturing.
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Verification And Validation jobs near you
Infographic showing various Verification And Validation job openings in California as of July 2026, with employment types broken down into 71% Full Time, and 29% Contract. Highlights an 94% In-person, and 6% Remote job distribution.

Verification & Validation Lead

Capstan Medical, Inc.

Santa Cruz, CA • On-site

Full-time

Re-posted yesterday

Job description

Reports to: Head of Software & Controls
Workplace Type: Hybrid (onsite in Santa Cruz 3 days/week)
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 meaningful, career-defining work.
Overview:
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. We're developing a groundbreaking robotic platform that gives surgeons superhuman precision in transcatheter valve deployment-and we need an exceptional V&V Lead to own the strategy that proves our systems meet the rigorous standards that patient safety demands.
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. This is a hands-on leadership role-you'll be writing protocols, executing tests at the bench, and building the V&V program that enables us to bring life-saving technology to patients.
Leadership & Strategy
  • Own the V&V strategy for the robotic surgical platform, defining the approach for software, system, and design validation activities
  • Plan and manage V&V project timelines, resource allocation, and deliverables aligned with program milestones and regulatory submissions
  • Establish and continuously improve V&V processes, templates, and infrastructure to scale with the organization
  • Mentor and guide V&V engineers, fostering technical growth and maintaining high standards for verification evidence

Cross-Functional Collaboration
  • Partner with systems engineering to influence system requirements, ensuring they are verifiable, traceable, and properly decomposed from user needs
  • Collaborate with regulatory affairs to shape submission strategy and ensure V&V deliverables meet FDA and notified body expectations
  • Work with risk management to ensure verification activities adequately address risk controls and software safety classification per IEC 62304 and ISO 14971
  • Engage with clinical and human factors teams to plan and execute design validation activities including simulated use and clinical evaluations
  • Represent V&V in design reviews, providing expert input on requirement clarity, testability, and verification approach

Technical Execution
  • Design and execute software verification test protocols demonstrating compliance with system and software requirements per IEC 62304
  • Personally execute test cases at the bench-we don't have a separate test execution team, and all engineers participate in running DV protocols
  • Own requirements traceability matrices linking User Needs through system requirements, software requirements, and verification evidence
  • Develop and execute test strategies spanning unit, integration, and system-level verification for real-time robotic control software
  • Author and review test protocols and reports that withstand regulatory scrutiny from FDA and notified body reviewers
  • Drive adoption of automated test frameworks that integrate with CI/CD pipelines while maintaining design control compliance

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
  • 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

Preferred:
  • Experience with robotic systems, motion control, or real-time embedded software testing
  • Experience building or scaling V&V functions in a startup or growth-stage environment
  • 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
  • Track record of successful FDA 510(k), De Novo, or PMA submissions
  • Exposure to usability engineering (IEC 62366) and design validation methodologies

Requirements:
  • BS in Computer Science, Software Engineering, Biomedical Engineering, or equivalent; MS preferred
  • 5-10 years of experience in software V&V, test engineering, or software quality in the medical device industry
  • Demonstrated leadership experience-formal or informal-in guiding V&V activities and mentoring engineers
  • Comfortable being hands-on: you're energized by executing tests yourself, not just delegating
  • Track record of delivering verification evidence packages for regulatory submissions
  • Experience working cross-functionally to influence requirements, risk management, and design decisions
  • 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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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