Senior Robotics Verification & Validation (V&V) Engineering Manager

Purpose

The Senior Robotics Verification & Validation (V&V) Engineering Manager is responsible for ensuring that robotic products meet all defined system and subsystem level requirements and are safe, effective, and compliant for their intended clinical use. This role plays a critical part in supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements.

The Senior Robotics V&V Engineering Manager leads a team of Verification & Validation and Integration Engineers, providing technical and people leadership to ensure that robotic systems meet all subsystem and system level requirements throughout development and release. Working cross functionally with systems, software, hardware, clinical, robotics, manufacturing, and quality teams, the Senior Robotics V&V Engineering Manager ensures that design outputs are verified and validated against user needs, intended use, system and subsystem requirements, and risk controls.

Key Responsibilities

• Lead a team of Verification & Validation and Integration Engineers to ensure robotic systems meet all defined subsystem and system level requirements.
• Collaborate closely with systems engineering, hardware, and software teams to ensure requirements are clearly defined, testable, and fully traceable from user needs and system/subsystem requirements through verification and validation.
• Define minimum testable requirements following design or requirement changes, applying a risk-based approach that considers essential performance and basic safety.
• Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression strategies to ensure robust requirements coverage.
• Oversee investigation, integration, reliability, and formal verification and validation testing.
• Prepare and deliver system-level V&V documentation, including summary reports and verification results.
• Review and approve sub-system verification deliverables to ensure alignment with overall system requirements.
• Design, validate, and implement test methods, including manual and automated test setups, to ensure they are suitable for verifying product requirements, including repeatability and reproducibility.
• Coordinate and manage engagement with external test facilities (e.g., NRTLs, EMC, and restricted materials laboratories) to ensure full regulatory compliance and adherence to internal company policies.
• Oversee the maintenance of robotics test lab facilities, ensuring all equipment and infrastructure are properly calibrated, serviced, and compliant with company safety, quality, and procedural standards.
• Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971).
• Support design transfer and product launch activities including complaints investigations.
• Investigate and document non-conformances, deviations, and test failures, drive root cause analysis and corrective actions.
• Interface with regulatory, quality, and manufacturing teams to support audits and inspections.
• Communicate business-related issues or opportunities to next management level.
• Follow all Company guidelines related to Health, Safety and Environmental practices.
• Ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices.
• Ensure personnel and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
• Support project resource and schedule planning.