Senior Robotics V&V Engineer

• Collaborate with systems engineering to ensure requirements clarity, testability, and traceability from user needs, system and sub-system requirements, through verification and validation.
• Define minimum testable requirements post-change (risk-based, essential performance, basic safety).
• Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression plans that ensure robust requirements coverage; this includes investigational, integration, reliability, and formal V&V 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.
• 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.
• 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.
• 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.
• 3+ years of experience in V&V engineering within the medical device industry.
• Experience with Class II or Class III medical devices is preferred.
• Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.
• 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).
• 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.

Demonstrates expertise in Verification and Validation (V&V) engineering for medical devices, with a strong focus on regulatory compliance, systems engineering principles, and effective communication. Proficient in developing test strategies and managing requirements throughout the product development lifecycle.

• Verification And Validation Engineering
• Medical Device Industry Experience
• Requirements Management Tools
• Regulatory Compliance (FDA, ISO)
• Test Automation Tools

• V&V Strategies
• Test Method Design
• Statistical Analysis
• Embedded Systems Testing
• Firmware/Software Testing

• Technical Writing
• Communication Skills
• Problem Solving

• CQE
• CQA
• Six Sigma

• Biomedical Engineering
• Systems Engineering
• Class II Medical Devices
• Class III Medical Devices
• Product Development Lifecycle

• DOORS
• Jama
• Polarion
• Python
• LabVIEW
• MATLAB