George Omae, a mechanical engineer by training, has over 23 years’ experience in the medical device industry and has worked in roles of increasing responsibility in Quality, Process Development, and R&D. He has had significant experience developing processes and products for 510k and PMA while working at Guidant, Boston Scientific, American Medical Systems, and Medtronic. As a Six Sigma Black Belt, he has trained and mentored engineers and other technical professionals in the application of quality engineering tools. He is also an experienced trainer for Test Method Validation, Process Validation, and Sampling Plans. George is also an adjunct instructor at the St Cloud State University graduate school (Medical Technology Quality (M.S.) and Corporate College Services (MBA – Quantitative Analysis, BS. Business Math and BS. Business Statistics).
B.S. Mechanical Engineering, Nairobi University
M.S. Manufacturing Systems Engineering, University of St. Thomas
M.S. Applied Statistics, Rochester Institute of Technology
MBA, Carlson School of Management, University of Minnesota