Principal Robotics Systems Engineer
Johnson & Johnson · Boston, MA
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Role summary
Principal Robotics Systems Engineer position leading systems engineering for a complex surgical robotic platform at Johnson & Johnson's Orthopaedics division. The role spans the full product lifecycle, from clinical requirements definition through regulatory submission, ensuring integration across hardware, software, controls, and clinical workflows in a safety-critical medical device environment.
What they're looking for
- Extensive experience in systems engineering for complex medical devices or robotic platforms
- Deep knowledge of FDA regulations, ISO 13485, IEC standards, and design control requirements
- Demonstrated expertise in requirements management, traceability, and flow-down processes
- Strong background in safety-critical system design and ISO 14971 risk management
- Proven ability to lead cross-functional teams and drive technical trade-off decisions
- Experience with electromechanical system architecture and software-hardware integration
What you'll be doing
- Lead systems engineering across surgical robotic platform lifecycle, including architecture definition and subsystem requirement decomposition
- Manage end-to-end requirements traceability from clinical needs through verification and validation activities
- Drive cross-functional collaboration among hardware, software, controls, mechanical, clinical, and V&V engineering teams
- Own system-level risk management activities including hazard analysis and risk control verification per ISO 14971
- Lead design control planning and documentation for FDA compliance and regulatory submissions
Privacy & handoff
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