Sr Manager R&D Mechanical Engineering

Johnson & Johnson Boston, Massachusetts, United States of America Updated 6 October 2026
PharmaMedTechRegulatory AffairsQuality Assuranceregulatory submissionfdaiso 13485croravesap

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. Job Function: R&D Product Development Job Sub Function: R&D Mechanical Engineering Job Category: People Leader All Job Posting Locations: Boston, 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 searching for Sr Manager R&D Mechanical Engineering to be based out of Boston, Massachusetts, USA or Grenoble, France with in office expectations of a minimum of 3 days per week. Purpose: Lead and grow a high-performing mechanical engineering team to develop current products and next-generation orthopedic robotic systems for the Joints robotics group. You will own mechanical architecture, design-for-manufacturability, prototype delivery, and some mechanical verification/validation while partnering closely with systems, software, electronics, clinical, quality, and regulatory functions to bring safe, effective robotic products from concept to production. Key Responsibilities: Lead, mentor, and grow a global mechanical R&D team. Drive hiring, performance management, and career development. team currently split between USA and France. Define mechanical system and sub-system architecture for robotic platforms. Translate clinical and product requirements into detailed mechanical designs, specifications, DFx, and engineering change controls. The role includes some hands-on part in parallel to people leadership. Deliver prototypes and production-ready designs on program schedule and budget; manage trade-offs between performance, cost, reliability, and manufacturability. Establish and drive robust verification & validation plans (unit, subsystem, system testing) and support clinical and bench testing programs. Ensure design outputs meet medical device quality and regulatory expectations (risk management, FMEA, design history file requirements, ISO 13485, FDA 21 CFR 820 familiarity). Partner with supply chain and manufacturing to qualify suppliers, support DFM/DFM reviews, ramp to production, and transfer designs to operations. Lead cross-functional design reviews and provide clear technical decision-making; escalate and mitigate technical and schedule risks. Manage project budgets, resource planning, and deliverable tracking for assigned programs. Qualifications: Required qualifications Bachelor’s or Master’s degree in Mechanical Engineering, Mechatronics, Robotics, Biomedical Engineering, or related field. 3+ years of people leadership experience (managing engineers/teams). Demonstrated experience designing electromechanical systems: actuators, gear trains, bearings, transmissions, mechanisms, and precision assemblies. Strong hands-on experience with CAD (SolidWorks, Creo or equivalent), GD&T, tolerance analysis, and rapid prototyping techniques. Track record of taking products from concept through verification and transfer to manufacturing. Excellent communication skills and ability to influence cross-functional and executive stakeholders. Preferred qualifications 10+ years of hands-on mechanical design experience, with minimum 5 years in medical device or robotics product development. Direct experience in surgical robotics, orthopaedics, or other implantable medical systems. Solid understanding of medical device design controls, risk management (FMEA), and verification/validation processes. Familiarity with actuators (electric, harmonic drives, motors), position/safety sensors, cable-driven systems, and sterile field considerations. Experience with regulatory submissions and design history file preparation. Knowledge of manufacturing processes relevant to medtech (micro-machining, injection molding, precision assembly, surface treatments, sterilization constraints). Advanced degree (MS/PhD) in relevant technical area. Experience working with global, matrixed organizations and cross-site teams. Core competencies and leadership behaviors Strategic thinker with bias for clear technical decisions and delivery. Strong coach/mentor with focus on developing engineers and building inclusive teams. Results-driven, accountable, and comfortable navigating ambiguity. Collaborative: builds alignment across engineering, clinical, quality, and operations. Customer-focused: prioritizes safety, clinical utility, and surgeon experience. Travel Some travel, domestic and international to be expected (supplier sites, manufacturing transfers, clinical support). 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. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal,

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