Sr Systems Engineer – Nav R&D

• Author, decompose and maintain system and subsystem requirements for assigned features. Keep them structured, traceable and communicated across multi-site teams.
• Perform system-level risk analysis, including hazard analysis, use risk analysis and FMEA, for assigned areas. Support risk cascade to subsystem teams.
• Work with software, hardware and V&V teams to make sure requirements are testable and fully traced from user needs through verification and validation.
• Develop use cases, user stories and workflows with clinical, marketing and human factors partners to define user needs and design inputs.
• Define and analyze mechanical, electrical and software interfaces. Support system integration, integration testing and issue resolution.
• Contribute to system architecture, functional diagrams and design trade-off studies under the guidance of Staff/Principal engineers.
• Support design reviews, change impact assessments and sustaining engineering for released products.
• Support regulatory submissions and DHF deliverables. Make sure system deliverables meet IEC 60601, ISO 14971 and IEC 62366 requirements.
• Engage with surgeons and clinical staff, including in lab and OR settings, to clarify user needs and evaluate system performance.
• Mentor junior engineers and co-ops on systems engineering methods and tools.
• Communicate business-related issues or opportunities to the next management level.
• Follow all Company guidelines on Health, Safety and Environmental practices, and ensure personal and Company compliance with all applicable regulations, policies and procedures.

• Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, Robotics or Mechatronics Engineering, or a related field.

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of relevant systems engineering experience in medical devices or another regulated industry.

• Experience with Design Controls, requirements management and risk management in a regulated environment.
• Experience with an ALM/requirements tool such as Polarion, Jama or DOORS.
• Working knowledge of IEC 60601, ISO 14971, ISO 13485 and IEC 62366.
• Experience with system integration and interface management across software, electrical and mechanical subsystems.
• Strong technical writing, communication and cross-functional collaboration skills.

• Advanced/graduate degree in engineering.
• Experience with surgical navigation, robotics or image-guided surgery systems.
• Experience developing orthopaedic medical devices.
• Experience supporting system design verification and validation testing.
• Experience with sustaining engineering and change management for released medical devices.
• Experience in an operating room setting supporting surgeons who use digital technology.
• Familiarity with MBSE/SysML or AI-assisted engineering tools.

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, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-PN2

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