Orthopedic Systems Engineer – Robotics & Digital Surgery

Hardware FYI; Boston (MA); On-site; USD 78,000 - 127,000; Full time

Benefits offered by this job

Vacation policy

Sick leave

Holiday pay

401(k) plan

Job summary

Johnson & Johnson Boston is seeking a System Engineer to drive digital and robotic technology in Orthopaedics. Based in Boston with 3 in-office days, you will develop system requirements, perform risk analysis, and coordinate cross-disciplinary teams across hardware and software.

You will work on system architectures, verification, validation, and regulatory submissions, ensuring safe and effective device performance.

Qualifications

• 1–2 years in a medical device new product development environment.
• BS in Systems, Biomedical Engineering, Robotics, or Mechatronics.
• Advanced/Graduate degree in engineering preferred.
• Experience with orthopedic medical device product development.
• Experience with surgical navigation or robotics.
• Experience with Design Controls and requirements management in a medical device environment.
• 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 system-level risk management and use-related risk analysis.
• Collaborate with subsystem teams on requirements and risk decomposition.
• Develop system architectures, functional diagrams, and system concepts.
• Support verification, validation, and product launch activities.
• Ensure traceability of requirements and risks across the system lifecycle.
• Develop use cases and user stories with cross-functional teams.
• Coordinate integration across hardware, software, and subsystems.
• Prepare results documentation for stakeholders and regulatory needs.
• Generate technical materials for diverse audiences.

Skills

Analytical Reasoning

MBSE

Requirements Analysis

Scripting Languages

Software Testing

SDLC

Regulatory Awareness

Education

BS in Systems, Biomedical Engineering, Robotics, or Mechatronics

Advanced/Graduate degree preferred

Tools

SAP PLM

Job description

Johnson & Johnson Boston is seeking a System Engineer to drive digital and robotic technology in Orthopaedics. Based in Boston with 3 in-office days, you will develop system requirements, perform risk analysis, and coordinate cross-disciplinary teams across hardware and software.

You will work on system architectures, verification, validation, and regulatory submissions, ensuring safe and effective device performance.