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

Location: Hybrid role based in Raynham or Boston, Massachusetts, United States

Salary: $137,000–$235,750 annually

Company

Johnson & Johnson MedTech develops healthcare and orthopaedic solutions, including robotics and digital surgery products.

What you will do

• Lead Verification & Validation and Integration Engineers developing and releasing robotic medical devices.
• Define traceable, testable requirements and develop system-level V&V strategies, master test plans, protocols, and regression strategies.
• Design, validate, and implement manual and automated test methods with appropriate repeatability and reproducibility.
• Prepare V&V reports, review subsystem verification deliverables, and support design transfer, product launches, complaints investigations, audits, and inspections.
• Investigate test failures, deviations, and non-conformances; lead root-cause analysis and corrective actions.
• Manage external testing facilities and maintain calibrated, compliant robotics laboratory equipment and infrastructure.

Requirements

• Bachelor’s or master’s degree in biomedical engineering, systems engineering, electrical engineering, or a related field.
• 7+ years of Verification & Validation engineering experience in the medical device industry.
• Strong knowledge of systems engineering principles and product development lifecycles, including V-model, waterfall, and Agile approaches.
• Experience with requirements management tools such as DOORS, Jama, or Polarion.
• Knowledge of applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and ISO 14971.

Nice to have

• Experience with Class II or Class III medical devices.
• Knowledge of embedded systems, firmware/software testing, or electromechanical systems.
• Experience with test automation tools and scripting languages such as Python, LabVIEW, or MATLAB.
• CQE, CQA, or Six Sigma certification, and experience with sample-size calculation and statistical analysis.

Culture & Benefits

• Inclusive work environment focused on healthcare innovation and improving patient outcomes.
• Participation in the company pension and 401(k) savings plans.
• Eligibility for a long-term incentive program.
• Paid vacation, sick time, holidays, parental leave, caregiver leave, volunteer leave, and other time-off benefits.
• Reasonable workplace accommodation is available for qualified individuals with disabilities.