Team

Michael Koucky

Principal Consultant

Michael is an engineer with more than 10 years of experience providing technical and design control expertise to the drug-device/biologic-device combination product and medical device industries. He has provided successful support to clients through all phases of the product life-cycle, from new product development through design transfer, life-cycle management, and end-of-life.

Academic & Professional Qualifications:
  • B.S. – Materials Science and Engineering, Ohio State University
  • M.S. – Biomedical Engineering, Ohio State University
  • M.S. – Biomedical Engineering, Rutgers University
Training, Quality Systems, & Specialties:
  • AAMI Combination Products

  • GDT – Geometric Dimensioning and Tolerancing

  • AMI (American Injection Molding Institute)