Navigation Systems Verification & Validation (V&V) Engineering Manager

Job Title Navigation Systems Verification & Validation (V&V) Engineering Manager Location Boston, Massachusetts or Raynham, Massachusetts, United States of America Job Description Lead and manage the Verification & Validation (V&V) function for navigation systems, ensuring that products meet all defined system‑ and subsystem‑level requirements and comply with regulatory, quality and safety standards. Responsibilities Lead a team of Verification & Validation and Integration Engineers to ensure navigation 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. Prepare and deliver system‑level V&V documentation, including summary reports and verification results. Review and approve 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 and 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 navigation systems 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, ensure 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 personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Perform other duties assigned as needed. Identify critical paths during product development, address bottlenecks and risks, and facilitate problem solving across R&D teams. Support project resource and schedule planning. Qualifications Required: 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). Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB). Excellent technical writing and communication skills. Preferred: Experience with ClassII or ClassIII medical devices. Knowledge of embedded systems, firmware/software testing, or electromechanical systems. Experience in surgical robotics or surgical navigation technologies. Certification in CQE, CQA, or Six Sigma. Proficient in sample size calculation and statistical methods for analyzing data. EEO & Disability Accommodation We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Johnson & Johnson is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability. Pay and Benefits Base pay range: $117,000.00 – $201,250.00. Vacation: 120 hours per calendar year. Sick time: 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents). 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 birth/adoption/foster care. Bereavement leave: 240 hours (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. Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), long‑term incentive program, and other general benefit programs. #J-18808-Ljbffr 6149-DePuy Synthes Products Inc. Legal Entity