Staff Navigation Systems Engineer, Robotics

Johnson & Johnson; Boston (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Long‑term incentive program

Retirement plan (401(k))

Vacation and leave benefits

Job summary

Johnson & Johnson in Boston, MA and Warsaw, IN seeks a Staff Systems Engineer to lead system requirements, risk analysis, and cross‑functional integration for orthopedic robotic platforms. You will guide designs from concept to validation, collaborate with hardware, software and marketing teams, and support regulatory submissions in a highly regulated environment.

The role emphasizes model-based systems engineering, design controls, and sustaining engineering with a focus on improving patient

Qualifications

• 8+ years of experience of relevant systems engineering.
• BS in Systems, Biomedical Engineering, Robotics, or Mechatronics.
• Advanced/Graduate degree in engineering preferred.
• Degree or experience in systems engineering.
• Experience with orthopedic medical device product development.
• Experience with surgical navigation or robotics.
• Experience with Design Controls and requirements management in a medical device development environment.
• Experience in ALM system such as Polarion
• Experience with sustaining engineering and change management of medical devices.
• Experience executing system design verification and validation testing.
• Knowledge of IEC 60601, ISO 14971, ISO 13485 and 62366.
• Experience in an operating room setting supporting surgeons in the use of digital technology.

Responsibilities

• Perform requirements management across multi-site teams.
• Conduct system level risk analysis in a regulated environment.
• Collaborate with subsystem teams on requirements and risk cascade.
• Develop design strategies, system architectures and functional diagrams.
• Evaluate multi-functional solutions to identify best design answers.
• Develop use cases and user stories with partners.
• Provide ongoing systems engineering support to existing products.
• Analyze interfaces and ensure high system performance and reliability.
• Work with hardware, electrical and software teams across product lifecycle.
• Support regulatory submissions and IEC 60601 compliance.
• Coach team members on systems engineering methodologies.
• Ensure compliance with health, safety and environmental practices.

Skills

Systems engineering

Orthopedic medical devices

Surgical navigation/robotics

Design Controls

ALM (Polarion)

MBSE

SDLC

Coaching

Education

BS in Systems, Biomedical Engineering, Robotics, or Mechatronics

Advanced/Graduate degree preferred

Experience in systems engineering

Tools

Polarion

SAP Product Lifecycle Management

Job description

Johnson & Johnson in Boston, MA and Warsaw, IN seeks a Staff Systems Engineer to lead system requirements, risk analysis, and cross‑functional integration for orthopedic robotic platforms. You will guide designs from concept to validation, collaborate with hardware, software and marketing teams, and support regulatory submissions in a highly regulated environment.

The role emphasizes model-based systems engineering, design controls, and sustaining engineering with a focus on improving patient