Orthopedic Systems Engineer – Robotics & MBSE

Johnson & Johnson Co.; Boston (MA); Hybrid; USD 78,000 - 127,000; Full time

Job summary

Johnson & Johnson’s Orthopaedics unit in Boston seeks a System Engineer to advance digital and robotic technologies for orthopedic devices. You will generate system requirements, conduct risk analysis, and coordinate cross-functional teams to define architectures and verification plans.

You will lead risk-based design strategies, support system integration, and contribute to regulatory submissions while collaborating with surgeons and engineers to ensure safety and performance.

Qualifications

• 1-2 years of experience 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 development 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 activities, including use-related risk analysis, in a highly regulated environment.
• Collaborate with subsystem teams on requirements and risk decomposition and cascade.
• Collaborate with cross-disciplinary teams in developing design strategies, system architectures, functional diagrams, and system concepts.
• Participate in system development, implementation, and integration to support successful verification, validation, and product launch.
• Identify, evaluate, and communicate system requirements and risks in concert with design teams throughout the system lifecycle.
• Partner with cross-functional stakeholders to develop use cases and user stories that further define system user needs, design requirements, and system risks.
• Support requirements traceability and change impact assessments across user needs, system requirements, subsystem requirements, and risk controls.
• Participate in system integration activities, including evaluation and troubleshooting of interactions across hardware, software, and subsystems.
• Participate in system verification, validation, and usability activities, including protocol development, test execution, analysis, and documentation of results.
• Support development and improvement of system workflows, usability, and instructions for use.
• Support regulatory submissions.
• Perform appropriate analyses to evaluate and support the safety and effectiveness of the system architecture.
• Generate and present technical material necessary for the understanding of stakeholders and users at all levels.

Skills

Analytical reasoning

Problem solving

MBSE

Requirements analysis

Education

BS in Systems, Biomedical Engineering, Robotics, or Mechatronics

Advanced/Graduate degree in engineering preferred

Tools

SAP PLM

Scripting languages

SDLC

Job description

Johnson & Johnson’s Orthopaedics unit in Boston seeks a System Engineer to advance digital and robotic technologies for orthopedic devices. You will generate system requirements, conduct risk analysis, and coordinate cross-functional teams to define architectures and verification plans.

You will lead risk-based design strategies, support system integration, and contribute to regulatory submissions while collaborating with surgeons and engineers to ensure safety and performance.