· Lead a team of Verification & Validation and Integration Engineers to ensure navigation 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. This includes oversight of investigational, integration, reliability, and formal verification and validation testing.
· Prepare and deliver system-level V&V documentation, including summary reports and verification results.
· Reviewing and approving 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, 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 navigation systems test lab facilities, ensuring all equipment and infrastructure are properly calibrated, serviced, and compliant with company safety, quality, and procedural standards; proactively identify and resolve issues to support uninterrupted testing and development workflows.
· 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.
· Responsible for communicating business-related issues or opportunities to next management level
· Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
· For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
· Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
· Performs other duties assigned as needed
· Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
· Support project resource and schedule planning.