Navigation Systems Verification & Validation (V&V) Engineering Manager
Johnson & Johnson Innovation
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Job summary
Johnson & Johnson is hiring a Navigation Systems Verification & Validation Engineering Manager in a hybrid role based at Raynham or Boston, MA. You will lead a team of V&V and integration engineers, ensuring risk-based, testable requirements are met and regulatory obligations are satisfied.
You will collaborate across systems, hardware, software, clinical, and quality teams to deliver robust verification and validation for navigation devices, supporting FDA/ISO compliance and product launches.
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.
- Experience with requirements management tools (DOORS, Jama, Polarion) and test automation tools (Python, LabVIEW, MATLAB).
- Excellent technical writing and communication skills.
Responsibilities
- Lead a team of Verification & Validation and Integration Engineers to meet subsystem and system requirements.
- Collaborate with systems, hardware, and software teams to ensure testable, traceable requirements.
- Define minimum testable requirements following design changes with a risk-based approach.
- Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices.
- Prepare and deliver system-level V&V documentation, including summary reports.
- Review and approve subsystem verification deliverables for alignment with requirements.
- Design, validate, and implement test methods, including manual and automated setups.
- Coordinate engagement with external test facilities to ensure regulatory compliance.
- Oversee navigation systems test lab facilities and maintain equipment calibration and safety standards.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971.
- Support design transfer and product launch activities including investigations.
- Investigate non-conformances, 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.
- Ensure adherence to Health, Safety and Environmental practices.
Skills
Education
Tools
Job description
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. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
R&D Product Development
Robotics
People Leader
Boston, Massachusetts, United States of America, Raynham, Massachusetts, United States of America
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are hiring for Navigation Systems Verification & Validation (V&V) Engineering Manager in a hybrid role to be based out of Raynham or Boston, MA
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 Navigation Systems V&V Engineering Manager leads a team of Verification & Validation and Integration Engineers, providing technical and people leadership to ensure that navigation systems meet all subsystem‑and system‑level requirements throughout development and release.
Working cross‑functionally with systems, software, hardware, clinical, navigation, manufacturing, and quality teams, the Navigation Systems V&V Engineering Manager ensures that design outputs are thoroughly verified and validated against user needs, intended use, system and subsystem requirements, and risk controls. This role requires strong technical depth, excellent collaboration and leadership skills, and the ability to operate effectively in a regulated, multidisciplinary environment.
- 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.
- 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 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.
- Responsible for communicating business-related issues or opportunities to next management level
- Responsible for following 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
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs 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:
- 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 Class II or Class III medical devices is preferred.
- Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.
- Experience in surgical robotics or surgical navigation technologies is a major plus.
- . Certification in CQE, CQA, or Six Sigma is a plus
- Proficient in sample size calculation and statistical methods for analyzing data.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
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 Aff Mission on Equality…
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.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com
#LI-PN2
- Computer Programming
- Consulting
- Critical Thinking
- Data‑Driven Decision Making
- Data Science
- Developing Others
- Inclusive Leadership
- Industry Analysis
- Innovation
- Leadership
- Manufacturing Technologies
- Product Knowledge
- Prototyping
- Quality Assurance (QA)
- Research and Development
- Robotic Automation
- SAP Product Lifecycle Management
- Team Management
$117,000.00 - $201,250.00
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long‑term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- 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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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