Execute the timely completion of engineering projects in the medical product category by analyzing project scope and determining project specifications, establishing test programs for product investigations and preparing reports for clients. Use knowledge of electrical safety to apply standard requirements, test methods and test equipment in order to complete product safety certification projects in the medical and laboratory product categories. Complete the initial product review, report creation, test program development, and final technical review of new work engineering projects, acting as the project handler of record. Provide technical assistance to clients in reference to product inspection and follow-up services. Responsible for account administration while promoting and explaining the benefits of new and existing services.
Master’s degree in electrical engineering or related
Two (2) years of electrical engineering experience in the medical device industry
Must have experience in each of the following: 1) Electrical Safety Standard(s) proficiency, including 60601 & 61010 and testing experience; 2) Experience in Certifications for CB scheme, CE marking and International regulatory registrations; 3) Experience in safety certification of surgical, diagnostic, patient monitoring, patient imaging and laboratory equipment; 4) Experience with risk management file evaluations per ISO 14971 and medical device software assessments per IEC 62304; 5) Experience with medical device usability assessment per IEC 62366.