Verification & Validation Lead

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

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

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

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