Senior Systems Engineer - Surgical Navigation R&D

NBSTSA; Boston (MA); Hybrid; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson’s Orthopaedics division is seeking a Senior Systems Engineer - Navigation R&D for a hybrid role based in Boston, MA or Warsaw, IN. You will own system requirements, risk analysis, and interface definitions, coordinating with software, hardware, human factors, V&V, quality and regulatory partners to deliver safe navigation systems for surgeons.

You will work with clinicians to define user needs, analyze interfaces, and support system integration and verification activities,

Qualifications

• Bachelor's degree in a relevant engineering field.
• 5+ years of systems engineering experience in medical devices or 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.

Responsibilities

• 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.

Skills

Systems engineering

Technical writing

Cross-functional collaboration

Verbal and written communication

Education

Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, Robotics or Mechatronics Engineering

Tools

Polarion

Jama

DOORS

Job description

Johnson & Johnson’s Orthopaedics division is seeking a Senior Systems Engineer - Navigation R&D for a hybrid role based in Boston, MA or Warsaw, IN. You will own system requirements, risk analysis, and interface definitions, coordinating with software, hardware, human factors, V&V, quality and regulatory partners to deliver safe navigation systems for surgeons.

You will work with clinicians to define user needs, analyze interfaces, and support system integration and verification activities,