• Develops system- and subsystem-level requirements for medical devices that include electromechanical hardware, software, disposables, and labeling. • Reviews systems engineering related processes and ensures they are current with industry standards and regulatory requirements. • Contributes to other R&D system engineering activities as needed including risk management, architecture review, V&V strategy, and post-market surveillance. • Keeps abreast of new developments in the industry and translates those developments into new and viable options for the organization and customers. • Investigates issues to determine root cause using established problem-solving tools. • Ensures that research and design methodologies meet established scientific and engineering standards. • Participates in design activities to ensure overall system performance is considered in product design decisions. • Presents technical information in a clear and precise manner. • Works independently with latitude for individual judgment. • Exercises judgment within defined procedures and practices to determine appropriate action.