Medical Safety Engineer

Found in: Resume Library US A2 - 1 week ago


Irvine California, United States Eurofins USA Consumer Product Testing Full time
Job Description

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 (phone number removed), ISO 14971, IEC (phone number removed)-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.


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