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Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…
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EMI/EMC & RF Compliance Testing/Worldwide Regulatory Project Management
Setup a Bluetooth RF & Protocol Qualification Test Lab. Was a Bluetooth Qualification Body (BQB) for 2 years. Performed and Managed FCC/CE/IC Regulatory Compliance Testing for various types of Bluetooth Module and End Products. Paticipated in many Bluetooth Expert Meetings.…
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Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
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RF, Wireless, Microwave, Analog, Digital and Video System and Design Engineering
Expert is an RF/Microwave Engineering Consultant with 33 years of experience in the areas of RF, Microwave, Wireless, Analog, and high-speed Digital/FPGA designs. Expert recently completed a Patent Research project on an ITC Section 337 lawsuit that involved a number…
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Toxicology (Benzene, Solvents, Metals); Medical Science and Microbiology (Causation); Environmental (Risk Assessment)
Expert has the Ph.D. in Microbiology with 30+ years of research and teaching experience with appointments in Molecular Microbiology and Immunology, School of Medicine; the Biomedical Sciences Department, and as Adjunct Professor of Pathology, College of Veterinary Medicine; and as…