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.