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

Johnson & Johnson Innovative Medicine•Boston, MA

23h•Hybrid

About The Position

The Senior Robotics Verification & Validation (V&V) Engineering Manager at Johnson & Johnson, within the Orthopaedics sector, 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 hybrid role, based out of Raynham or Boston, MA, is critical for 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 manager leads a team of Verification & Validation and Integration Engineers, providing both technical and people leadership to ensure robotic systems meet all requirements throughout development and release. This involves extensive cross-functional collaboration with systems, software, hardware, clinical, robotics, manufacturing, and quality teams to verify and validate design outputs against user needs, intended use, system/subsystem requirements, and risk controls. The role demands strong technical depth, excellent collaboration, and leadership skills, operating effectively within a regulated, multidisciplinary environment.

Requirements

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).

Nice To Haves

Experience with Class II or Class III medical devices.
Knowledge of embedded systems, firmware/software testing, or electromechanical systems.
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.
Proficient in sample size calculation and statistical methods for analyzing data.

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. This includes oversight of investigation, integration, reliability, and formal verification and validation 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.
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, responsible for ensuring 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.

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; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
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
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year