Job Description Summary
The Staff Systems Engineer is a technical leadership position in the Diabetes Care space responsible for guiding the engineering of a complex system by analyzing customer needs and required functionality early in the development cycle, documenting requirements, then proceeding with design synthesis and system validation while considering the complete problem. The project requires the development of new mechanical device technologies and the implementation of connectivity technologies to provide value to patients through the burgeoning fields of the Internet of Things (IoT) and the diabetes digital ecosystem in order to improve insulin therapy. The individual would have responsibility for managing requirements and maintaining traceability from user needs and customer requirements to functional requirements, physical allocations, design specifications and performance specifications and would be expected to act as a bridge between the engineering disciplines and between the mechanical, electrical and software subsystems. The position will report to the Associate Director or R&D, Innovation and NPD.
The responsibilities can include, but are not limited to: leading the development of requirements, creating systems behavior diagrams, enabling the decomposition of the requirements to hardware & software component specifications through tradeoff analysis, development of models & simulations and technology prototyping and assessments, performing risk analysis and failure modes and effects analysis (FMEA) and ensuring appropriate techniques are used in the final verification & validation of the solution.
The individual will interface both internally and externally with medical/clinical teams, customers, marketing personnel, and quality/regulatory functions to enable all aspects of product development are considered in the design.
Master’s Degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Computer Engineering or Applied Physics.
A minimum of 8 years of post-educational professional experience in Medical Device Systems Engineering, with at least 2 years of project leadership experience.
Working knowledge of applicable standards for medical devices: FDA QSR, ISO 13485, ISO 14971, IEC 60601.
PhD in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Computer Engineering or Applied Physics.
10+ years of professional experience.
Six Sigma experience and/or certification.
Excellent written & verbal communication skills
Self-directed with the ability to learn and adapt quickly to new technologies and trends
Leadership, mentoring, organization and coordination skills
Demonstrated customer focus, track record of innovation and publication
Primary Work Location
USA NJ - Franklin Lakes