Staff Systems Engineer (Medical Robotics)

Staff Systems Engineer (Medical Robotics)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:Bachelor's or Master's degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field.10+ years of experience in systems engineering, preferably within the medical device industry or similarly regulated environments.Demonstrated experience contributing to the development and successful launch of Class II or III medical devices.Proficient in requirements management tools such as JAMA, DOORS, or -depth knowledge of standards such as 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304.Strong analytical skills with a systems-thinking approach to solving complex technical challenges.Excellent verbal and written communication skills to effectively convey complex technical concepts to diverse audiences.Strong problem-solving skills and ability to work in dynamic, cross-functional teams.High attention to detail and organizational skills to manage multiple priorities and deliverables.Self-motivated, adaptable, and capable of working independently while collaborating across disciplines.Willingness to travel domestically or internationally up to 20% of the timeSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Medical Equipment Manufacturing #J-18808-Ljbffr

Created: 2025-09-18