Senior Robotics Verification & Validation (V&V) Engineer
About The Position
The Senior Robotics Verification & Validation (V&V) Engineer 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 Sr. Robotics V&V Engineer works cross functionally with systems, software, hardware, robotics, manufacturing, and quality teams to ensure design outputs are thoroughly verified and validated against user needs, intended use, system and subsystem requirements, and risk controls. This role requires strong technical depth, excellent collaboration skills, and the ability to operate effectively in a regulated, multidisciplinary environment.
Requirements
- 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.
Nice To Haves
- Experience with Class II or Class III medical devices
- Knowledge of embedded systems, firmware/software testing, or electromechanical systems
- Certification in CQE, CQA, or Six Sigma
Responsibilities
- 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.
- 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.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
