Johnson & Johnson
Boston Massachusetts United States of America, MA
Shift: Full time
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. Job Function: R D Product Development Job Sub Function: Robotics Job Category: People Leader All Job Posting Locations: Boston, Massachusetts, United States of America, Raynham, Massachusetts, United States of America Job Description: About Orthopaedics 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 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 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. Job 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. · 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, q