Senior Systems Engineer, Surgical Navigation R&D

Johnson & Johnson Co.; Boston (MA); Hybrid; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson's Orthopaedics division is hiring a Senior Systems Engineer - Navigation R&D for a hybrid role in Boston, MA or Warsaw, IN. You will own system requirements, risk analyses, and interface definitions for navigation features, partnering with software, hardware, human factors, and regulatory teams to deliver safe, testable medical devices.

You will mentor junior engineers, support design reviews, and contribute to system architecture while ensuring IEC/ISO compliance and effective

Qualifications

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

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.
• Work with software, hardware and V&V teams to ensure 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 guidance of Staff/Principal engineers.
• Support design reviews, change impact assessments and sustaining engineering for released products.
• Support regulatory submissions and DHF deliverables. Ensure system deliverables meet IEC 60601, ISO 14971 and IEC 62366 requirements.
• Engage with surgeons and clinical staff 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 regulatory compliance.

Skills

Cross-functional collaboration

Design controls

Requirements management

Risk management

ALM tools

System integration

Technical writing

Education

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

Advanced/graduate degree in engineering

Tools

Polarion/Jama/DOORS

Job description

Johnson & Johnson's Orthopaedics division is hiring a Senior Systems Engineer - Navigation R&D for a hybrid role in Boston, MA or Warsaw, IN. You will own system requirements, risk analyses, and interface definitions for navigation features, partnering with software, hardware, human factors, and regulatory teams to deliver safe, testable medical devices.

You will mentor junior engineers, support design reviews, and contribute to system architecture while ensuring IEC/ISO compliance and effective