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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…
Business Optimization, Engineering, Analytical Rigor, Technical Expertise, Due Diligence, Critical Business Analysis to Develop/Implement Change for Profitable Growth
We fuse business optimization, engineering expertise, analytical rigor, and technical expertise to help companies perform due diligence, critical business analysis and design/implement continuous improvement programs to achieve profitable growth. Our firm provides expertise in commercial development, new product development, sourcing,…
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…
Electrical Engineering
Expert has broad and deep capability in motors and generators. He knows the design process from the centerline out. He has designed machines with special design constraints. He knows the theories of operation and control, and can specify a machine…
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…
Low Temperature Cofired Ceramic, Microsystems manufacturing, Six Sigma, Lean & Process Engineering
An accomplished professional that has increased yields to well over 90% and reduced flow times by over 75%. Developed new processes and products that have generated new customers and millions in sales. These new processes and products have generated 3…
Intellectual Property, Patents, Validity Invalidity, Infringement Noninfringement, Product Liabilty
Expert has extensive experience in product liability which include: Direct participation in more than 300 litigation cases with in-depth evaluations of multiple high-dollar claims and lawsuits. Forensic Analyses. Expert witness reports, inspections, accident reconstruction, photographs, occupant kinematics & injury causation,…
Powder Coating Formulation, Powder Application & Powder Coating Process (All Aspects)
Expert has worked in the powder coating industry for over 25 years and is a member of multiple associations., Expert has previously held various sales, marketing, and technical positions for additional companies. Providing a wide variety of technical services to…
Maintenance Engineering, Reliability and Logistics.
Expert is a consultant with formal training and extensive experience in the application of methodologies for solving problems related to: * Maintenance Engineering: -Organization, planning, programming and maintenance control under MPT or RCM approaches. -Design and implementation of Maintenance Management…
Adhesives, Coatings, Materials and Process Chemistry
Expert is a professional chemist with 35+ years experience in academics, commercial, aerospace, electronics, and automotive-related industries. A hands-on consultant on various aspects of engineering materials, their applications and processing, with extensive experience in materials and process engineering, product research…