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Expert in 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…
Expert in Metal Forming
Expert is an experienced court-recognized testifying expert witness for metal fabrication and stamping litigation. He has published 88 technical articles for leading trade magazines. He possesses direct, hands-on, cradle-to-grave experience with progressive, transfer, and tandem stamping dies for Class A…
Expert in Data Center Cooling
Expert is a Thermal Management Service Technical Manager at a data center solutions global leader company. His portfolio includes working on multiple commissioning projects for data center installation, on the aspect of cooling design and implementation. He has contributed to…
Expert in Medical Device Development
BSME - Mechanical Engineer: 40+ years Medical Device design & development (13 patents) - Drug delivery devices, respiratory care devices, hemodialysis, and blood collection devices, in-vitro diagnostic instrument, and cartridge devices; 25+ years medical device product liability and patent infringement…
Expert in Cost-Effective Clean Energy-Based Technologies, Small Molecules, Polymers, Nanomaterials; Quality Management
Overview: - R&D/Quality/Manufacturing Scientist/Manager with over 20 years of cumulative development/manufacturing/product launch/process scale-up/project management experience involving advanced materials/devices/technologies at chemical/optoelectronic R&D and Manufacturing facilities. - Passionate in coordinating continuous improvement efforts with cross-functional teams at all levels of the organization…
Expert in Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Expert in Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Expert in Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt
Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…
Expert in Microelectronic components materials and reliability
Expert has 31 years of experience (the most recent 12 years in the position of Senior Scientist responsible for company analytical laboratories) at three companies manufacturing advanced semiconductor devices for military, aerospace, medical device, and other applications, and an additional…
Expert in Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…