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Medical Device Engineering
Collaborative and results-oriented medical device engineer with extensive new product development experience. Superior record of delivering results through teamwork, innovation, and focus. Versatile team member having experience in marketing, mechanical engineering, manufacturing, and project management. 47 patents in medical device…
RoHS market entry requirements for markets such as EU, CE Marking, ISO 12100
Compliance engineer with over 25 years experience with domestic and internal safety standards with a desire to assist customers in balancing the market entry requirements with their internal quality and risk assessment goals
Nephrology and Managed Care
Experience: Chief Medical Officer, Chief Health Officer, Chief Value Officer, Value Creation, Medical Operations, Healthcare Strategy, Complex Medical Conditions, Total Cost of Care, Affordability, Real-World Value Evidence and Outcomes Research, Medical Devices, Healthcare technology, Pricing and Market Access, Value Based…
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…
Human Factors, Ergonomics, Medical Device and Pharmaceutical Industry
Expert heads one of the world's leading consultancy to the medical device and pharmaceutical industry. Expert is among the preeminent leaders in the healthcare human factors field. Expert has been an expert witness in the areas of ergonomics and human…
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…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…
Otolaryngologist and Head and Neck Surgery
Expert is a board certified Otolaryngologist and Head and Neck Surgeon who practiced for 35 years. He has medical business consulting and medical legal witness experience. Expert founded his practice and grew it to become one of the leading practices…
Physical Therapy
1969 B.S. SUNY Downstate College of Health Related Professions, 1971 M.S. Exercise Physiology Long Island University, Masters Degree Thesis: A Comparison of the Effectiveness of Eccentric Vs. Concentric Strength Training Programs on the Contractile Strength of the Elbow Flexors. 1995…