Staff Navigation Systems Engineer – Orthopedic Robotics

Johnson & Johnson MedTech; Warsaw (IN); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson in the United States is seeking a Staff Systems Engineer for the Navigation R&D team, based in Warsaw, IN and Boston, MA. You will generate system requirements, perform risk analysis, and collaborate with cross-disciplinary teams across hardware, software, and marketing to advance orthopedic robotic platforms.

Responsibilities include implementing design controls, managing ALM workflows, and supporting regulatory submissions while ensuring IEC 60601 and ISO 14971 alignment.

Qualifications

• 8+ years of systems engineering experience.
• BS in Systems Engineering, Biomedical Engineering, Robotics, or Mechatronics.
• Advanced/Graduate degree 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 in ALM systems 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, ensuring requirements are structured, organized, maintained, and communicated across multi-disciplined and multi-site teams.
• Be responsible for performing system level risk analysis, including use risk analysis, in a highly regulated environment.
• Collaborate with sub system teams on requirements and risk cascade.
• Collaborate with cross-disciplinary teams developing design strategies, system architectures, functional diagrams and participate in the generation of concepts.
• Evaluate multi-functional solutions to help identify and select the best design answers for specific requirements.
• Partner with key partners to develop use cases and user stories to further define system user needs, design requirements and system risks.
• Provide continuing systems engineering support to existing products and sustaining engineering activities.
• Analyze mechanical, electrical, and software interfaces. Work with cross functional teams on system integration and interface management, ensuring high system performance and reliability.
• Partner with hardware engineering, electrical engineering, software engineering, marketing, and testing using a systems engineering approach throughout the product development lifecycle.
• Support regulatory submissions.
• Ensure system requirements, designs and deliverables meet Medical Device Electrical Safety (IEC 60601) Requirements.
• Coach team members on System Engineering methodologies and best practices.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Job description

Johnson & Johnson in the United States is seeking a Staff Systems Engineer for the Navigation R&D team, based in Warsaw, IN and Boston, MA. You will generate system requirements, perform risk analysis, and collaborate with cross-disciplinary teams across hardware, software, and marketing to advance orthopedic robotic platforms.

Responsibilities include implementing design controls, managing ALM workflows, and supporting regulatory submissions while ensuring IEC 60601 and ISO 14971 alignment.