Jose M. Justiniano has 17 years of experience in quality, reliability, and technical product development management with several leading medical device companies. In 1990, Justiniano pioneered the adoption of Six Sigma concepts for medical devices and pharmaceuticals, becoming a trainer and management champion of Six Sigma Green and Black Belts. He has trained thousands of vice presidents, directors, managers, life sciences scientists, engineers, and FDA inspectors. He has been acknowledged by the ASQ as a CSSBB. Justiniano completed his MBA at the University of Cincinnati and his MS in industrial engineering and operations research at Cornell University. He learned the original concepts of Six Sigma from Genichi Taguchi and Mikel Harry, and is an ASQ CQE, CRE, and CQA. He also has attained ISO 9000 Lead Assessor Certification by the Institute of Quality Assurance.

Dr. Venky Gopalaswamy is currently a corporate director of DFSS at a leading Class III medical device company. Prior to this, he was an Engineering Unit Manager responsible for innovative process technology development and Six Sigma support. He also was a Manager and Acting Director of Quality Sciences where, as a Six Sigma champion, he was instrumental in the successful implementation of Six Sigma initiatives to improve both manufacturing process and product design for minimally invasive medical devices. He has instructed and consulted in the areas of quality and reliability engineering, safety engineering, and engineering graphics. Dr. Gopalaswamy has an undergraduate degree in mechanical engineering and a Ph.D.

in industrial and systems engineering from the University of Illinois. He is an ASQ CQE, CRE, CQM, and a company-certified Six Sigma Black Belt.