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Medical Device Packaging and Device Packaging Process Consultant

Technical Consultant #1643


Expertise

  • Medical device packaging and packaging process equipment.
  • Documentation and execution for package and equipment validation.
  • Medical device package design and documentation.
  • Packaging equipment and process analysis for production, including purchase resources.
  • Problem solving and analysis for packaging defects.
  • Technical training for packaging and QC departments.
  • Complete audits for FDA compliance of package design, equipment and validation.
  • Analysis of medical device packaging design for packaging compatibility.
  • University educator of graduate courses in Package Engineering.
  • Expert witness in prosecution of patent defense.

Experience

Undisclosed Company, President and Owner, 1983 - Present

  • Medical devise and general package engineering consulting firm.
  • Complete research and development and quality control testing laboratory.

The Design Group, Partner, 1980 - 1983

  • Package engineering consulting firm.
  • Complete graphic design and finished artwork studio.

Avon Products, Suffern, NY, Manager of Jewelry Quality Assurance, 1979 - 1980

  • Coordinated activity between production, purchasing, and quality assurance.
  • Developed quality inspection and test methods.

Workshop Guild for the Blind, Director of Workshops, 1978 - 1979

  • Managed over 100 handicapped people.
  • Provided contract packaging.
  • Managed a paper converting operation.

C.R. Bard, Manager of Package Engineering for corporation and divisions, 1971 - 1978

  • Provided package and equipment design for medical devices.

Becton-Dickinson Corporation, Supervisor of Package Development, 1967 - 1971

  • Provided package and equipment design for medical devices.

Union Camp Research Division, Package Development Engineer, 1964 - 1971

  • Provided package design and paper development for paper products.

RCA-Astro Electronics Division, Environmental Test Engineer, 1961 -1964

  • Provided environmental testing for satellites prior to sending into orbit.
  • Worked on Tiros, Ranger, and Relay satellites.

Honors & Publications


Academic and Professional Affiliations

  • Association of Medical Instrumentation (AAMI)
  • ASTM International
  • American Society for Quality (ASQC)
  • Institute of Packaging Professionals (IOPP)

Achievements

  • Retired Captain USAR & NYS National Guard, automotive maintenance and repair.
  • Co-Author of multiple ASTM test methods and standards.
  • Author of numerous technical articles for industry trade publications.
  • Selected as one of 100 Notable People in the Medical Device Industry.
  • Inventor of the Seal Matrix Program for optimizing heat sealing process.
  • 100 Most Notable in Medical Device Industry.
  • MD&DI Judge for Medical Device Awards.
  • Guest lecturer at University of Wisconsin.

Publications

  • Co-Author of Medical Device (Hardcover).
  • Numerous in Medical Device & Diagnostic Industry magazine.
  • Numerous in Package Development Magazine.
  • Numerous in Pharmaceutical & Medical Packaging News.
  • U.S. Patent-Medical Procedure Tray.
  • U.S. Patent-Medical Package.
  • U.S. Patent-Systems for Testing Packages.

Education

  • M.B.A. Seton Hall University, Newark, NJ
  • B.S.M.E. Lehigh University, Bethlehem, PA
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