Senior Systems Engineer, Surgical Navigation R&D

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

Job summary

Johnson & Johnson seeks 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 interface definitions, coordinating with software, hardware, V&V, and regulatory teams to deliver safe, testable navigation solutions for orthopaedics.

The role requires 5+ years in medical devices or regulated industries, design controls experience, and collaboration with surgeons in OR settings.

Qualifications

• 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.
• Knowledge of IEC 60601, ISO 14971, ISO 13485 and IEC 62366.

Responsibilities

• Author, decompose and maintain system and subsystem requirements for assigned features.
• Perform system-level risk analysis including hazard, use risk and FMEA.
• Define and analyze mechanical, electrical and software interfaces; support integration testing.
• Develop use cases and workflows with clinical, marketing and human factors teams.

Skills

Systems engineering

Regulated environment

Technical writing

Cross-functional collaboration

MBSE

Surgical navigation experience

Education

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

Tools

Polarion

Jama

DOORS

Job description

Johnson & Johnson seeks 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 interface definitions, coordinating with software, hardware, V&V, and regulatory teams to deliver safe, testable navigation solutions for orthopaedics.

The role requires 5+ years in medical devices or regulated industries, design controls experience, and collaboration with surgeons in OR settings.