Senior Systems Engineer – Surgical Navigation R&D (Hybrid)

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

Job summary

Johnson & Johnson MedTech is hiring a Senior Systems Engineer – Navigation R&D for a hybrid role based in Boston, MA or Warsaw, IN. You will own system requirements, risk analyses and interfaces for surgical navigation features, collaborating across software, hardware, human factors, V&V, quality and regulatory teams.

You will mentor engineers, contribute to architecture, and support regulatory deliverables to ensure safe, reliable navigation systems for orthopaedics.

Qualifications

• Bachelor’s degree in Systems, Biomedical, Electrical, Mechanical, Robotics or Mechatronics Engineering or a related field.
• 5+ years of 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.
• Perform system-level risk analysis, including hazard analysis, use risk analysis and FMEA.
• Ensure requirements are testable and traceable from user needs through verification and validation.
• 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.
• Contribute to system architecture, diagrams and design trade-off studies.
• Support design reviews, change impact assessments and sustaining engineering.
• Assist regulatory submissions and DHF deliverables; ensure IEC/ISO compliance.
• Engage with surgeons and clinical staff to clarify needs and evaluate performance.
• Mentor junior engineers and co-ops; communicate issues to management.

Skills

Systems engineering

Regulated industry

Design controls

Requirements management

ALM tools

IEC standards

System integration

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Tools

Polarion

Jama

DOORS

Job description

Johnson & Johnson MedTech is hiring a Senior Systems Engineer – Navigation R&D for a hybrid role based in Boston, MA or Warsaw, IN. You will own system requirements, risk analyses and interfaces for surgical navigation features, collaborating across software, hardware, human factors, V&V, quality and regulatory teams.

You will mentor engineers, contribute to architecture, and support regulatory deliverables to ensure safe, reliable navigation systems for orthopaedics.