Orthopaedic Systems Engineer - MedTech & Robotics

Biopharma Asia; Boston (MA); On-site; USD 78,000 - 127,000; Full time

Job summary

Johnson & Johnson in Boston seeks a System Engineer to join the Orthopaedics digital and robotic technology team. You will participate in system requirements generation, risk analysis, and cross-disciplinary collaboration to define architectures and support integration.

The role involves development, verification, validation, regulatory support, and creating technical materials for stakeholders. Ideal candidates have 1-2 years in medical device development, a BS in an engineering field, and

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

MBSE

Requirements analysis

Scripting languages

Problem solving

Technical writing

Regulatory knowledge

Education

BS in Systems

Biomedical Engineering

Robotics

Mechatronics

Advanced degree

Tools

SAP PLM

Job description

Johnson & Johnson in Boston seeks a System Engineer to join the Orthopaedics digital and robotic technology team. You will participate in system requirements generation, risk analysis, and cross-disciplinary collaboration to define architectures and support integration.

The role involves development, verification, validation, regulatory support, and creating technical materials for stakeholders. Ideal candidates have 1-2 years in medical device development, a BS in an engineering field, and