Lead Systems Engineer (Medical Robotics)

Staff Systems Engineer (Technical Lead)

The Company :

Our client is a well funded startup company in the medical robotics space. They currently have a successful commercial product with several new exciting products in their pipeline. This exciting opportunity will help grow and shape the quality organization for years to come.

About The Team :

The Staff Systems Engineer will be a technical leader and expert contributor responsible for driving the development and integration of complex surgical robotic systems. This individual will work closely with cross-functional teams to define system-level architectures, manage requirements, oversee risk analysis, and ensure compliance with regulatory standards. This is a high-impact role that requires strategic thinking, problem-solving, and technical expertise to deliver world-class medical devices.

A Day In The Life Of Our Staff Systems Engineer :

• Technical Leadership : Provide deep technical expertise and act as a subject matter expert in systems engineering principles to drive innovative solutions for surgical robotic platforms.
• System Architecture and Requirements : Define, develop, and refine system-level architectures and requirements, ensuring traceability and alignment with stakeholder needs and regulatory requirements.
• Risk Management : Conduct and lead system-level risk analyses (e.g., FMEA, FTA) to proactively identify and mitigate risks, ensuring compliance with ISO 14971.
• Design Integration : Coordinate the integration of mechanical, electrical, software, and clinical subsystems to ensure cohesive and robust system performance.
• Verification and Validation : Develop, plan, and execute system verification and validation activities to confirm product safety and efficacy.
• Collaboration and Communication : Serve as a liaison between engineering, clinical, quality, regulatory, and program management teams, ensuring alignment and effective communication throughout product development.
• Regulatory Compliance : Prepare and review technical documentation, including design history files, risk management files, and support for regulatory submissions (e.g., FDA 510(k), EU MDR).
• Continuous Improvement : Drive process improvements and best practices within the systems engineering function to enhance efficiency and effectiveness.

About You :