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

Johnson & Johnson Innovative Medicine•Boston, MA

2d•$137,000 - $235,750•Hybrid

About The Position

The Senior Robotics Verification & Validation (V&V) Engineering Manager 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. The role supports 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. Working across systems, software, hardware, clinical, robotics, manufacturing, and quality teams, the manager ensures design outputs are verified and validated against user needs, intended use, system and subsystem requirements, and risk controls. The role provides technical and people leadership in a regulated, multidisciplinary product-development environment. The position is hybrid and located in Boston, Massachusetts. The anticipated base pay range is $137,000 to $235,750. Employees may participate in the company’s retirement and savings plans, and are eligible for various time-off benefits subject to plan and policy terms. The company has announced plans to separate its Orthopaedics business as DePuy Synthes; following completion of the transaction, the position is anticipated to become an employee of DePuy Synthes, subject to applicable conditions.

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 in the medical device industry.
Strong understanding of systems engineering principles and product development lifecycles, 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.
Certification in CQE, CQA, or Six Sigma.
Proficiency in sample-size calculation and statistical methods for data analysis.

Responsibilities

Lead Verification & Validation and Integration Engineers to ensure robotic systems meet defined subsystem- and system-level requirements.
Collaborate with systems, hardware, and software teams to define testable requirements and maintain traceability from user needs and system/subsystem requirements through verification and validation.
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 for complex medical devices, including system verification protocols and regression strategies.
Oversee investigation, integration, reliability, 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 and setups, including consideration of repeatability and reproducibility.
Coordinate external test facilities, including NRTLs, EMC laboratories, and restricted materials laboratories, to support regulatory compliance and internal policies.
Oversee maintenance of robotics test laboratories, ensuring 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 complaints 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 guidelines and ensure subordinates follow them and have necessary resources in good condition.
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

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year, subject to policy and hire date.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to policy and hire date.
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 a child’s birth, adoption, or foster care placement.
Bereavement Leave: up to 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.