Senior Systems Engineer - Surgical Navigation R&D

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

Job summary

Johnson & Johnson is hiring a Senior Systems Engineer – Navigation R&D. This hybrid role is based in Boston, MA or Warsaw, IN, requiring up to 10% travel domestically or internationally.

You will own system requirements, risk analysis and interface definitions for navigation systems in orthopaedics, collaborating with software, hardware, human factors, V&V, quality, and regulatory teams. You will mentor junior engineers, contribute to architecture and design trade studies, and support regulatory

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 a 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. Ensure traceability across multi-site teams.
• Perform system-level risk analysis, including hazard analysis, use risk analysis and FMEA, for assigned areas.
• Collaborate with software, hardware and V&V teams to ensure testable and fully traced requirements.
• Develop use cases, user stories and workflows with clinical, marketing and human factors partners.
• Define and analyze mechanical, electrical and software interfaces; support system integration and testing.

Skills

Systems engineering

Risk analysis

Requirements management

Technical writing

Cross-functional collaboration

V&V collaboration

Education

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

Tools

Polarion

Jama

DOORS

Job description

Johnson & Johnson is hiring a Senior Systems Engineer – Navigation R&D. This hybrid role is based in Boston, MA or Warsaw, IN, requiring up to 10% travel domestically or internationally.

You will own system requirements, risk analysis and interface definitions for navigation systems in orthopaedics, collaborating with software, hardware, human factors, V&V, quality, and regulatory teams. You will mentor junior engineers, contribute to architecture and design trade studies, and support regulatory