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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Purpose The Navigation Systems Verification & Validation (V&V) Engineering Manager is responsible for ensuring that navigation 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 Manager leads a team of Verification & Validation and Integration Engineers, providing technical and people leadership to ensure navigation systems meet all subsystem‑ and system‑level requirements throughout development and release. 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. This includes oversight of investigational, 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 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 such as 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 the next management level. Follow all Company guidelines related to Health, Safety and Environmental practices as applicable. 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. Required Qualifications 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 such as DOORS, Jama, Polarion. Familiarity with test automation tools and scripting languages such as Python, LabVIEW, MATLAB. Excellent technical writing and communication skills. Preferred Qualifications Experience with Class II or Class III 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. Proficiency in sample size calculation and statistical methods for analyzing data. Pay Base pay range: $117,000.00 – $201,250.00. Benefits 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 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. EEO & 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. Please contact us to request accommodation. 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. #J-18808-Ljbffr Johnson & Johnson MedTech