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Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
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…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Consumer and Medical Product Development, Structural Analysis and Design for Manufacturing
This expert's fingerprints are on many successful products - from satellites orbiting in space to tiny surgical instruments in the operating room. He has contributed to a wide range of product categories including automotive, office, as seen on TV, consumer…
Product Design and Manufacturing (Medical Devices, Electronics, Opto-Mechanical)
For the last 20 years, Expert was designing product and piecing up various parts using different materials and processes. Her expertise lies in designing plastics parts, sheet metal, and metal casting. In Expert's career, she worked with suppliers to deliver…
Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
Global leader and serial entrepreneur in the medical device industry with multiple successes in building companies, teams, products, and revenues. Experienced at bringing new products to the world market in a high-growth dynamic environment. Experienced Board member and Chairman in…
Product Development and Manufacturing Technology Transfer in Composite Materials for Industrial, Biotech and Medical Devices
Expert's principal expertise lies in conducting original research, development, and evaluation of alternative process capabilities, in support of new product development. His work has typically led to the establishment of new manufacturing platforms for a variety of material science-oriented businesses…
Semiconductor Manufacturing Intellectual Property, Materials Science, Failure Analysis
Expert is a renowned professional who seamlessly amalgamates scientific, engineering, and economics principles to deliver exceptional results for his clients. With an illustrious career spanning numerous years, he specializes in building superior products, evaluating the technical and economic viability of…
Lean Manufacturing and Operations
As Principal of his process improvement firm, Expert provides practical and realistic support for business improvement efforts. He offers over 40 years' hands-on international experience in a variety of industries -- including Dental Labs, Medical Devices, Clinical Research, Electronics, Aerospace,…
Resistors, Inductors, and Current Sense
Expert is a customer-focused, results-oriented, Manufacturing Executive with extensive experience leading F500 and privately held global organizations to profitable growth by improving efficiency and building teamwork. He has successfully managed operations through international joint ventures, turnarounds, start-ups and acquisition integrations.…