Principal R&D Systems Engineer

Job Function: R&D Product Development

Job Category: Scientific/Technology

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. We are searching for Principal Robotics Systems Engineer to be based out of Boston, MAPurpose: Principal Robotics Systems Engineer is a highly experienced individual contributor and technical specialist responsible for leading all aspects of systems engineering for a complex surgical robotic platform across its full product lifecycle. This role ensures cohesive system behavior across hardware, software, controls, and clinical workflows, applying rigorous systems engineering principles to a safety-critical medical device. 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 Principal Robotics Systems Engineer leads the end-to-end requirements flow-down process, including 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 role drives alignment between system architecture decisions and downstream implementation to ensure performance, safety, reliability, and usability objectives are achieved. This role plays a critical part 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 quality system requirements. Responsibilities include ownership of system-level risk management, requirements traceability, verification strategies, and design reviews. The Principal Robotics Systems Engineer works in close collaboration with electrical, software, controls, mechanical, clinical, quality, manufacturing, and verification & validation (V&V) teams. As a technical leader without direct people management responsibility, this role drives cross-functional integration, resolves complex technical trade-offs, and leads system-level decision-making to deliver a cohesive, compliant, and high-performing robotic system.

Job Responsibilities: Lead all aspects of systems engineering for a complex surgical robotic platform, including definition of system architecture, decomposition of system functionality, and development of clear, testable system and subsystem requirements. Own the end-to-end requirements lifecycle, ensuring seamless flow-down and traceability from clinical user needs, surgeon workflows, and business objectives through system, subsystem, hardware, and software requirements, and ultimately verification and validation. Drive cross-functional collaboration across hardware, software, controls, mechanical, clinical, and V&V teams to ensure system requirements are technically sound, testable, and aligned with real-world clinical use cases and robotic performance needs. Lead system architecture development, ensuring robust integration of electromechanical hardware, embedded and application software, control algorithms, sensing, actuation, and user interaction within a safety-critical environment. Lead system-level risk management activities in accordance with ISO 14971, including hazard analysis, risk control definition, verification of risk controls, and residual risk assessment, with emphasis on robotic behaviors, software contributions, and clinical use scenarios. Own software-related system requirements, including definition of system behaviors, operational concepts, user stories, and detailed clinical and technical use cases that align software functionality with system performance and user workflows. Ensure execution of design control activities in compliance with internal procedures and external regulatory requirements across the full product lifecycle (concept through commercialization).Lead system-level design and architecture reviews, driving cross-functional alignment, resolving technical trade-offs, and ensuring readiness for regulatory submission and product release. Define, control, and maintain system interfaces and interface specifications, ensuring compatibility and robust integration across hardware, software, and mechanical domains. Drive design for reliability practices, including robust design methodologies and Design of Experiments (DoE), across system and subsystem development. Partner with Human Factors and Clinical Engineering to ensure usability requirements are met and use-related risks are effectively mitigated. Lead standards and regulatory compliance activities, including requirements flow-down and alignment with FDA 21 CFR Part 820, ISO 13485, IEC 60601, IEC 62304, ISO 14971, and other applicable standards. Collaborate with reliability and test engineering teams to ensure defined reliability, durability, and service life requirements are achieved, including support for accelerated life testing and system-level reliability analysis. Support design transfer and product launch activities, including manufacturing readiness, service considerations, and post-market surveillance (complaints, field issues, and failure analysis).Apply Model-Based Systems Engineering (MBSE) and UML methods to define, analyze, and manage system architecture, requirements, interfaces, and behavior. Lead investigation of nonconformances, deviations, and test failures, performing root cause analysis and driving corrective and preventive actions (CAPA) to closure. Interface with regulatory affairs, quality, manufacturing, and clinical teams to support audits, inspections, and regulatory submissions. Communicate system-level risks, constraints, and opportunities to senior management, translating technical and clinical insights into clear business impact and actionable recommendations. Identify critical paths and address development risks, facilitating structured problem-solving across R&D teams. Support project planning activities, including input to resource and schedule planning.

Qualifications/Requirements: Bachelor's or master's degree in Systems Engineering, Software Engineering, Mechatronics, Electrical Engineering, or related field.8+ years of experience in multidisciplinary systems engineering. Experience with Class II or Class III medical devices is preferred. Knowledge of embedded systems, firmware/software testing, and electromechanical systems.5+ years of experience in surgical robotic systems or complex multidisciplinary medical devices. Strong understanding of systems engineering principles and product development lifecycle (e.g., Vmodel, 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. Certification in CQE, CQA, or Six Sigma is a plus. Proficient in sample size calculation and statistical methods for analyzing data.

Preferred Skills: Computer Programming, Cost-Benefit Analysis (CBA), Critical Thinking, Data Science, Industry Analysis, Innovation, Manufacturing Technologies, Organizing, Problem Solving, Process Improvements, Prototyping, Quality Assurance (QA), Quality Control (QC), Research and Development, Robotic Automation, SAP Product Lifecycle Management, Technical Credibility 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. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Johnson &