Sr Robotics Systems Engineering Manager

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 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 Software/Systems Engineering 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, weu2019re 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 thatu2019s 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 We are hiring for Senior Robotics System Engineer in a hybrid role to be based out of Raynham or Boston, MA Job Overview: The Senior Robotics Systems Engineering Manager leads a team of multidisciplinary systems engineers and provides technical and organizational leadership for a complex surgical robotic platform across its full product lifecycle. This role is responsible for ensuring cohesive system behavior across hardware, software, controls, and clinical workflows, applying rigorous systems engineering principles to a safetyu2011critical medical robotic system. This position partners closely with commercial, clinical, and product management stakeholders to translate clinical user needs, surgeon workflows, and business objectives into well-defined system requirements and successful new product introductions. The role ensures that customer, clinical, and regulatory expectations are effectively decomposed into robust, traceable system and subsystem solutions. The role leads the endu2011tou2011end requirements flow-down process, starting with identification and engagement of clinical and business stakeholders, definition of user and system requirements, development of system architecture, and decomposition into clear, testable subsystem requirements. The position drives alignment between system architecture decisions and downstream implementation to ensure performance, safety, reliability, and usability objectives are met. The Senior Robotics Systems Engineering Manager plays a critical role in regulatory submissions and product releases by leading the planning, execution, and documentation of design control activities in compliance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements. This includes ownership of system-level risk management, requirements traceability, verification strategies, and design reviews. This role requires close and continuous collaboration with electrical engineering, software, controls, mechanical engineering, clinical, quality, manufacturing, and verification & validation (V&V) teams. The Senior Robotics Systems Engineering Manager ensures crossu2011functional integration, resolves technical trade-offs, and drives system-level decision-making across disciplines to deliver a cohesive, compliant, and highu2011performing robotic system. Job Responsibilities: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: u00b7 Lead and develop a multidisciplinary systems engineering team responsible for the definition of system architecture, decomposition of system functionality, and development of clear, testable systemu2011level and subsystem requirements for a complex surgical robotic platform. u00b7 Own the endu2011tou2011end requirements lifecycle, ensuring seamless flowu2011down and traceability from clinical user needs, surgeon workflows, and business objectives through system, subsystem, hardware, and software requirements, and ultimately through verification and validation. u00b7 Drive close collaboration across hardware, software, controls, mechanical, clinical, and V&V teams to ensure system requirements are technically sound, fully testable, and aligned with realu2011world clinical use cases and robotic performance needs. u00b7 Lead system architecture development for robotic systems, ensuring tight integration of electromechanical hardware, embedded and application software, control algorithms, sensing, actuation, and user interaction within a safetyu2011critical medical device environment. u00b7 Lead systemu2011level risk management activities in accordance with ISO 14971, including hazard analysis, risk control definition, risk verification, and residual risk assessment, with particular focus on robotic behaviors, software contributions to risk, and clinical use scenarios. u00b7 Own and lead software subsystem requirements, including definition of user stories, system behaviors, operational concepts, and detailed clinical and technical use cases that align software functionality with robotic system performance and user workflows. u00b7 Accountable for execution of all design control activities, ensuring compliance with internal procedures and external regulatory requirements throughout the product lifecycle, from concept through commercialization. u00b7 Chair and lead systemu2011level design reviews, architecture reviews, and risk mitigation reviews, driving crossu2011functional alignment, resolving technical tradeu2011offs, and ensuring readiness for regulatory submission and product release. u00b7 Drive the integration of designu2011foru2011reliability practices, such as robust design and Design of Experiments (DoE), across system and subsystem development. u00b7 Partner with Human Factors (HF) Engineering and Clinical Engineering to ensure the system meets usability requirements and that all identified useu2011related risks are effectively mitigated through appropriate risk control measures. u00b7 Lead standards and regulatory compliance efforts, owning the standards requirements flowu2011down and ensuring alignment with FDA 21 CFR Part 820, ISO 13485, IEC 60601, IEC 62304, ISO 14971, and other applicable standards. u00b7 Collaborate with reliability and test engineering teams to ensure the robotic system meets defined reliability, durability, and service life requirements, including support for accelerated life testing and systemu2011level reliability analysis. u00b7 Support design transfer and product launch activities, including manufacturing readiness, service considerations, and postu2011market surveillance activities such as complaints investigation and field issue analysis. u00b7 Utilize Modelu2011Based Systems Engineering (MBSE) and UML practices to define, analyze, and manage system architecture, requirements, interfaces, and behavior. u00b7 Investigate and document nonconformances, deviations, and test failures, leading root cause analysis, defining corrective and preventive actions, and ensuring proper documentation and closure. u00b7 Interface with regulatory affairs, quality, manufacturing, and clinical teams to support internal and external audits, inspections, and regulatory submissions. u00b7 Communicate systemu2011level risks, roadblocks, and opportunities to senior management, translating technical and clinical insights into clear business impact and actionable recommendations. u00b7 Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams. u00b7 Support project resource and schedule planning. Qualifications/Requirements: . Bacheloru2019s or masteru2019s degree in systems engineering, Mechatronics Electrical Engineering, or related field u00b7 7+ years of experience in multidisciplinary systems engineering. u00b7 Experience with Class II or Class III medical devices is preferred. u00b7 Knowledge of embedded systems, firmware/software testing, and electromechanical systems. u00b7 5+ years of experience in surgical robotic systems or complex multidisciplinary medical devices. u00b7 Strong understanding of systems engineering principles and product development lifecycle (e.g., V-model, waterfall, Agile). u00b7 Experience with requirements management tools (e.g., DOORS, Jama, Polarion). u00b7 Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB). u00b7 Excellent technical writing and communication skills. u00b7 Certification in CQE, CQA, or Six Sigma is a plus. u00b7 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 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._ _For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit #LI-PN2 Required Skills: Preferred Skills: Developing Others, Inclusive Leadership, Innovation, Leadership, Operations Management, Process Improvements, Requirements Analysis, Research and Development, Researching, SAP Product Lifecycle Management, Scripting Languages, Software Acquisitions, Software Development Management, Software Engineering Practices, Software Quality Assurance (SQA), Stakeholder Engagement, Systems Development Lifecycle (SDLC), Tactical Planning, Team Management, Technologically Savvy, Vendor Management The anticipated base pay range for this position is : $137,000.00 - $235,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Companyu2019s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companyu2019s 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 u2013120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado u201348 hours per calendar year; for employees who reside in the State of Washington u201356 hours per calendar year Holiday pay, including Floating Holidays u201313 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave u2013 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave u2013 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave u2013 80 hours in a 52-week rolling period10 days Volunteer Leave u2013 32 hours per calendar year Military Spouse Time-Off u2013 80 hours per calendar year For additional general information on Company benefits, please go to:

Created: 2026-04-27