Job Description

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:

• 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 similar.
• In-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 time

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