I have served successfully as both a software engineer and a clinical scientist in the research, design and development of innovative and industry leading medical software and medical devices. I have equal experience in the design and execution of device and pharmaceutical clinical trials. I am currently seeking worldwide opportunities to grow.I have nearly 30 years experience in the cardiology field (I entered the field while in college) and my experiences range from early anti-arrhythmic trials to the CAST study, through software experiences such as exercise stress testing, Holter monitoring and both implantable and external cardiac defibrillation. And yes, I have even spent a significant number of years involved in clinical care.I am published in abstracts, posters and manuscript and have several patents.Currently I lead and manage international development teams in large and small projects, develop internal standards and systems, teach risk regulatory and QMS and provide related consults.I am highly skilled in developing teams and of sensitive to the subtleties of working in the international communities and across differing cultures. I have built departments and organizations from scratch and have experience designing and deploying ISO 13485, ISO 9001 and GAMP 5 compliant design control and quality systems.Member of AAMIPast Member of ISPE, IEEEParticular quality expertise: ISO 13585, ISO 14971, IEC 62304, GAMP 5, 21CFR 820Particular device standard expertise: AAMI/IEC 60601-2-47, AAMI/IEC 60601-2-27, AAMI EC57, AAMI DF80, AAMI EC71In addition to the engineering background I have extensive experience in clinical analysis and interpretation of cardiac arrhythmia, ST segment and QT segment.On the business side, I have a long-standing reputation of identifying industry, technology and regulatory trends early and providing accurate recommendations on how to successfully navigate these changes.