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

Johnson & Johnson•Boston, MA

1d•Hybrid

About The Position

Johnson & Johnson is seeking a Senior Robotics Verification & Validation (V&V) Engineering Manager for its Orthopaedics team. This hybrid role is located in Boston, Massachusetts. The position leads Verification & Validation and Integration Engineers and ensures robotic products meet system- and subsystem-level requirements and are safe, effective, and compliant for their intended clinical use. It supports regulatory submissions, product releases, design transfer, and launch through planning, executing, and documenting V&V activities in accordance with applicable FDA regulations, ISO 13485, IEC standards, and quality-system requirements. The manager works cross-functionally with systems, software, hardware, clinical, robotics, manufacturing, quality, regulatory, and other teams. The role oversees requirements traceability, test strategies and plans, system and subsystem verification, validation, integration, investigation, reliability, and regression testing. It also manages external testing-facility engagement and robotics test-lab readiness, investigates test failures and non-conformances, supports audits and inspections, and contributes to project resource and schedule planning. The role requires a relevant engineering degree and at least seven years of medical-device V&V engineering experience, along with strong systems-engineering and product-development lifecycle knowledge and experience with requirements-management tools. Preferred qualifications include experience with Class II or III medical devices, embedded or electromechanical systems, test automation and scripting, quality or Six Sigma certification, and statistical analysis skills.

Requirements

Bachelor’s or master’s degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, or a related field.
At least 7 years of V&V engineering experience within the medical-device industry.
Strong understanding of systems-engineering principles and the product-development lifecycle, such as V-model, waterfall, or Agile.
Experience with requirements-management tools such as DOORS, Jama, or 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 such as Python, LabVIEW, or MATLAB.
Excellent technical-writing and communication skills.
CQE, CQA, or Six Sigma certification.
Proficiency 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 subsystem- and system-level requirements.
Collaborate with systems engineering, hardware, and software teams to define testable requirements and maintain traceability from user needs and system/subsystem requirements through V&V.
Define minimum testable requirements following design or requirement changes, using a risk-based approach that considers essential performance and basic safety.
Develop and execute V&V strategies and master system test plans, including system verification protocols and regression strategies.
Oversee investigation, integration, reliability, and formal verification and validation testing.
Prepare and deliver system-level V&V documentation, including summary reports and verification results.
Review and approve subsystem verification deliverables for alignment with overall system requirements.
Design, validate, and implement manual and automated test methods suitable for verifying product requirements, including repeatability and reproducibility.
Coordinate engagement with external test facilities, including NRTLs, EMC facilities, and restricted-materials laboratories.
Oversee robotics test-lab facilities and ensure equipment and infrastructure are calibrated, serviced, and compliant with safety, quality, and procedural standards.
Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and ISO 14971.
Support design transfer, product launch, and complaint investigations.
Investigate and document non-conformances, deviations, and test failures; drive root-cause analysis and corrective actions.
Work with regulatory, quality, and manufacturing teams to support audits and inspections.
Communicate business-related issues or opportunities to the next management level.
Follow company Health, Safety and Environmental practices and ensure subordinates follow applicable guidelines and have the resources needed to do so.
Ensure personnel and company compliance with applicable federal, state, local, and company regulations, policies, and procedures.
Identify critical paths, bottlenecks, and risks during product development and facilitate problem solving across R&D teams.
Support project resource and schedule planning.

Benefits

Consolidated retirement plan (pension) and 401(k) savings plan, subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year, with different amounts specified for residents of Colorado and Washington.
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, or foster care of a child.
Bereavement leave: 240 hours for an immediate family member and 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.