FPCNational - Alaska

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Under the direction of the Director of Product Development and the Project Manager, the Development Engineer II works in a cross-functional Design Team to develop innovative and creative reprocessing techniques for new products. The Design Teams will integrate user needs into product and process specifications for manufacturing as well as prepare all testing and supporting documentation for FDA clearance.

Minimum Education & Experience:
 4 year Bachelor’s Degree in engineering (Mechanical, Biomedical, Electrical, Chemical)

 Licensed Engineer preferred

 Career Readiness Certification (Gold level) preferred

 7-10 years in engineering discipline

 Experience in SPC and root cause analysis

 Product Development experience preferred

 Experience working with multiple discipline projects

 Knowledge of FDA Quality System Requirements (QSR) Part 820 a plus

 Strong computer experience and knowledge in MS Suite (Word, Excel, Outlook, PowerPoint, MS Project)