Senior Robotics Verification & Validation Engineering Manager

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.
• 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 robotics 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.
• Communicate business-related issues or opportunities to next management level.
• Follow all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, ensure 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.
• 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.

• Bachelor’s or master’s degree in biomedical engineering, Systems Engineering, Electrical Engineering, or related field.
• 7+ years of experience in V&V engineering within the medical device industry.
• Strong understanding of systems engineering principles and product development lifecycle (e.g., V-model, waterfall, Agile).
• Experience with requirements management tools (e.g., DOORS, Jama, Polarion).
• Preferred:
  Experience with Class II or Class III medical devices is preferred.
• Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.
• Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).
• Excellent technical writing and communication skills.
• Certification in CQE, CQA, or Six Sigma is a plus.
• Proficient in sample size calculation and statistical methods for analyzing data.

• Verification and Validation (V&V)
• Requirements management
• Test methods design
• Risk-based approach
• Test automation
• Embedded systems
• Firmware testing
• Electromechanical systems
• Statistical methods
• Sample size calculation

• Communication
• Technical writing
• Problem solving
• Team leadership
• Collaboration
• Project management
• Root cause analysis
• Regulatory compliance
• Organizational skills
• Interpersonal skills

• CQE
• CQA
• Six Sigma