System Engineer

JOB DESCRIPTION:

Investigates and defines clinical, functional, and technical requirements for new algorithms.
• Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, and translates these into specific system requirements/interface specifications.
• Participates in a broad cross-functional review of work output.
• Strong experience in System-level testing
• Experience on hardware experience, especially electromechanical devices is a plus
• Required Medical Device Standards experience.
• Contributes to the evaluation and validation of a specific system or project before submission
• Interacts with functional groups as necessary to conduct feasibility studies, technology assessments, concept studies, or benchmarking studies.
• Identifies and resolves 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.
• Complies with U.S. Food and Drug Administration (FDA) regulations, regulatory requirements, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, and vendors required.
System Testing Plan Creation