Senior Robotics Verification & Validation; V&V Engineer

Job Function: R&D Product Development

Job Sub Function: R&D Software/Systems Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Boston, Massachusetts, United States of America;
Raynham, Massachusetts, United States of America

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle;

spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness.

We are searching for the best talent to join our Orthopaedics team as a Senior Robotics Verification & Validation (V&V) Engineer to be located in Raynham, MA or Boston, MA.

Purpose:

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.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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…