System EngineerInvestigate and define clinical, functional, and technical requirements for new algorithms.Gather and analyze input requirements for medical devices, supporting instrumentation/service infrastructure, and translate these into specific system requirements/interface specifications.Participate in a broad cross-functional review of work output.Strong experience in system-level testing.Experience on hardware, especially electromechanical devices is a plus.Required medical device standards experience.Contribute to the evaluation and validation of a specific system or project before submission.Interact with functional groups as necessary to conduct feasibility studies, technology assessments, concept studies, or benchmarking studies.Identify and resolve issues, escalating as appropriate.Demonstrated experience in system software testing using DOORS.Experience on cardiac management device testing is a plus.Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.Comply with U.S. Food and Drug Administration (FDA) regulations, regulatory requirements, operating procedures, processes, and task assignments.Maintain positive and cooperative communications and collaboration with all levels of employees, customers, and vendors required.