System Engineering Lead Role Overview
Key Responsibilities and Expectations:
* Provide technical leadership and expertise to guide cross-functional teams through the full product lifecycle.
* Shape product architecture, define system and sub-system requirements, ensure traceability and documentation for regulatory submissions.
* Lead system-level design and development for new and existing medical products, ensuring alignment with stakeholder needs.
Key Technical Skills Include:
* Technical Leadership: Guide large-scale project teams, communicate complex deliverables effectively, and promote engineering excellence.
* Requirements & Architecture: Define product architectures, translate stakeholder inputs into clear, traceable system requirements.
* Integration & Testing: Oversee system integration and testing activities, supporting verification and validation across hardware, software, UX, and systems.
* Documentation & Tools: Own and maintain design control documentation, SOPs, and requirements using tools like DOORS and Modern Requirements.
The Ideal Candidate Will Possess:
* Proven experience in leading technical project teams (HW, SW, UX, Systems) through the product lifecycle.
* Strong ability to lead large teams, communicate complex technical deliverables effectively.
* Experience in writing SOPs, guidance, and technical documentation.
Bachelor's or Master's degree in Engineering, Systems Engineering, Biomedical Engineering, or related field is preferred. 5+ years of progressive experience as a senior/lead engineer in product development are required.