Michael Ortega
Principal Quality Engineer @Edwards Lifesciences
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WORK HISTORY
Principal Quality Engineer @Edwards Lifesciences
Irvine, CA, US
Owned Design Control for next generation TAVR delivery system. Exerted positive influence with new product development efforts, including implementing Voice of the Customer, establishing design inputs/outputs, Executing Design Verification & Validation, and Risk Management. Delivered Design Requirements and Risk Documentation for expanded medical indication for treatment of high-risk patient populations enabling integration with active clinical trials. Supported new component design qualification activity including supplier selection, assessments of vendor qualification strategy, technical drawing review and capability assessments. Incorporated reliability and capability analysis assessments in Design and proto-manufacturing processes. Drove risk management integration with source selection, system integration and downstream processes.
EDUCATION
University of Southern California
B.S, Astronautical Engineering
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