Senior Product Safety Project Medical Engineer

Reports to:  Director of East Coast Safety or Engineering Manager along with Chief Engineer, MedicalDepartment: Medical Safety BusinessTasks/Responsibilities:Serve as a customer technical contact.Interpret medical standards and apply the requirements to products under investigation; including but not limited to IEC/EN/AAMI/CSA 60601-1, ISO 14971, IEC 60601-1-6.Create and implement test plans; conduct the required tests in accordance with the applicable standard(s), procedures and ensure results are documented.Ensure that test equipment is calibrated or tested and operates properly.Interface with and update the lab manager.Review files and reports prepared by other project engineers; including but not limited to peer reviews.Conduct preliminary design reviews.Monitor multiple projects.Prepare certification reports and related documents (e.g., approval letters, test report forms, etc.).Assists department with quoting medical projects.Assist Sales with closing new work.