Verification & Validation Lead (Software / Systems)

Overview

An innovative medical device company is developing a next-generation robotic platform designed to support complex minimally invasive procedures. We are seeking an experienced Verification & Validation (V&V) Lead to define and drive the strategy ensuring the system meets rigorous performance, safety, and regulatory requirements.

This role will lead verification and validation activities across a highly integrated system including software, hardware, and electromechanical subsystems. The position requires both technical leadership and hands-on execution, working cross-functionally with systems engineering, software development, quality, regulatory, and clinical teams.

What You’ll Do

Leadership & Strategy

• Own the verification and validation strategy across system and software components

• Define V&V plans aligned with program milestones and regulatory submission timelines

• Establish scalable V&V processes, documentation standards, and test infrastructure

• Provide mentorship and technical guidance to engineers supporting verification activities

Cross-Functional Collaboration

• Partner with systems engineering to ensure requirements are verifiable, traceable, and properly decomposed from user needs

• Collaborate with regulatory and quality teams to ensure testing activities support submission and compliance requirements

• Work with risk management teams to ensure verification activities adequately address risk controls and safety classifications

• Support design validation activities, including simulated use and human factors testing where applicable

• Participate in design reviews, providing input on requirements clarity, testability, and verification strategy

Technical Execution

• Develop and execute software verification test protocols demonstrating compliance with system and software requirements

• Execute bench-level testing and system-level validation activities

• Maintain requirements traceability matrices linking user needs, system requirements, software requirements, and verification evidence

• Develop and implement verification strategies spanning unit, integration, and system-level testing

• Author and review verification protocols and reports suitable for regulatory review

• Support development of automated testing approaches integrated with development workflows while maintaining design control compliance

Skills

• Strong knowledge of software lifecycle processes for medical devices (IEC 62304)

• Understanding of risk management principles (ISO 14971) and how verification supports risk controls

• Experience developing verification strategies for complex medical device systems

• Experience managing V&V timelines, resources, and deliverables

• Familiarity with requirements management and traceability tools (e.g., Jama, DOORS, Polarion, or similar)

• Excellent technical documentation and communication skills

• Ability to drive alignment across engineering, quality, and regulatory teams

• Understanding of the medical device design control process

Preferred Experience

• Experience testing complex electromechanical or software-driven systems

• Experience helping build or scale V&V programs in early-stage or high-growth organizations

• Familiarity with test automation frameworks and scripting (Python preferred)

• Experience developing test fixtures, hardware-in-the-loop systems, or bench testing environments

• Knowledge of medical device regulatory frameworks (FDA, ISO 13485, EU MDR)

• Experience supporting regulatory submissions such as 510(k), De Novo, or PMA

• Exposure to usability engineering and design validation methodologies

Requirements

Experience & Background

• BS in Computer Science, Software Engineering, Biomedical Engineering, or related field (MS preferred)

• 5–10 years of experience in verification & validation, software test engineering, or software quality within regulated medical device environments

• Experience providing technical leadership in V&V activities

• Comfortable working hands-on with system testing and verification

• Demonstrated experience generating verification documentation for regulatory submissions

• Experience collaborating across engineering, quality, regulatory, and product teams

Work Environment

• Ability to work onsite several days per week at the company’s engineering facility in Northern California