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Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Design for Test, Test Strategy, SMT Mfg, High-Speed Dig Design & PCB Layout, EMI/EMC, Digital Design
Expert has over thirty year’s experience in the design, manufacturing, and test areas. His initial education was in Industrial Engineering (IE) and Business Administration. After receiving his BSEE/MSEE, where he majored in digital design, computers, and software. Expert became highly…
Medical Device Total Quality
FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…
X-Ray Imaging
Expert is the inventor, designer, and project scientist/program manager of a number of different X-ray imaging systems, ranging from satellite-based X-ray telescopes to large systems for nondestructive imaging of 50 ton rocket motors and nuclear pressure vessels. Expert has both…
Business Strategies
Strategic Planning; Project Planning; Performance Measurements; Balanced Scorecard: Expert has extensive experience in strategic planning, and C-level team facilitation. He has conducted strategic business planning for manufacturing, construction, publishing, distribution, and service industries. He has been involved with formulating mission…
Fermentation, Product Recovery, Bioprocess Scale-Up, Bioinformatics, Former ISO 9000 Auditor
Expert (pronounced moy-man, ) is a former certified ISO 9000 auditor. Expert advises on productivity and quality assurance improvements, preparations for current Good Manufacturing Practices (cGMP) for FDA compliance. As an expert user of mainframes, minicomputers and microprocessors, he is…