Senior Product Safety Project Medical Engineer

Reports to:  Director of East Coast Safety or Engineering Manager along with Chief Engineer, Medical

Department: Medical Safety Business

Tasks/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.