Senior Systems Engineer, Surgical Navigation R&D

Brighter Signals; Warsaw (IN); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation - 120 hours/year

Sick time - 40 hours/year

Holiday pay - 13 days/year

Parental Leave - 480 hours/year

Bereavement Leave - 240 hours

Job summary

Johnson & Johnson’s Orthopaedics team seeks a Senior Systems Engineer for Navigation R&D. You’ll own system requirements, risk analyses, and interfaces, collaborating with software, hardware, human factors, and regulatory partners to deliver safe, reliable surgical navigation systems.

You’ll work across labs and OR settings, mentoring junior engineers, ensuring traceability from user needs through verification and validation, with travel up to 10%. Hybrid role in Boston or Warsaw, IN.

Qualifications

• Bachelor's degree in Systems, Biomedical, Electrical, Mechanical, Robotics or Mechatronics Engineering or related field.
• 5+ years of systems engineering experience in medical devices or regulated industry.
• Experience with Design Controls, requirements management and risk management.
• 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 and maintain system and subsystem requirements; ensure traceability.
• Perform system-level risk analysis including hazard analysis and FMEA.
• Coordinate with software, hardware and V&V teams to ensure testable requirements.
• Develop use cases, workflows with clinical, marketing and human factors teams.
• Define and analyze mechanical, electrical and software interfaces; support integration testing.
• Contribute to system architecture and design trade-off studies.
• Support design reviews, impact assessments and sustaining engineering.
• Support regulatory submissions and DHF deliverables per IEC/ISO requirements.
• Engage with surgeons and clinical staff to clarify user needs and evaluate performance.
• Mentor junior engineers and co-ops on systems engineering methods.

Skills

Systems engineering

Medical devices

Design Controls

ALM tools

IEC 60601

ISO 14971

ISO 13485

MBSE/SysML

Education

B.S. in Systems/Mechatronics

Tools

Polarion

Jama

DOORS

Job description

Johnson & Johnson’s Orthopaedics team seeks a Senior Systems Engineer for Navigation R&D. You’ll own system requirements, risk analyses, and interfaces, collaborating with software, hardware, human factors, and regulatory partners to deliver safe, reliable surgical navigation systems.

You’ll work across labs and OR settings, mentoring junior engineers, ensuring traceability from user needs through verification and validation, with travel up to 10%. Hybrid role in Boston or Warsaw, IN.