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International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…
New Product Development, Lean, Six Sigma Blackbelt, Semiconductors/MEMS
Expert has had extensive process engineering experience with a variety of types of CVD reactors, including atmospheric, vacuum/thermal, and plasma enhanced. He has developed copper CVD precursors, developed low-stress/controlled stress dielectric films, and metal films. He wrote a book on…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Marine: Diesel, Gasoline, Natural Gas Fueled Engines, Heavy Duty Equipment, Power Co-generation
Expert has studied and worked with most types of engines and engine systems throughout his career. His focus has been in operations, maintenance, reliability and failure investigations and analysis. Engine systems includes all of the ancillary equipment that it takes…
Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in…
Electronic and Mechanical Device Reliability, Failure Analysis, Risk and Safety Assessment
Expert is an expert in the fields of reliability, risk, and safety assessment. He performs electronic and mechanical device reliability analysis, failure analysis, failure modes and effects analysis, and fault tree analysis. Expert is an expert in the fields of…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…
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…
Forensic Electrical Electronic Engineering, Fire Investigations, Patent Infringement, Reverse Engineering, and Failure Analysis
Expert has worked in electronic forensics and patent infringement analysis. He specializes in all types of electronic devices, systems and products. Expert is a registered Electrical PE in the following states: North Carolina, South Carolina, Virginia, West Virginia, Tennessee, Georgia,…
Product Development High Stakes Problem Solving – Expert in Design of Experiments
He began developing and seeing results from his Design Of Experiments techniques at the General Motors Research Labs in 1986. He has refined and tested them in various environments, including automotive, aerospace instrumentation, armament technology and medical products in roles…