Team

Kenny Lin

Principal Project Manager

Kenny joins Suttons Creek with over 10 years of experience in the regulated medical device space. He has a robust background in assay development, design controls, manufacturing and technology transfer, biosafety, GLP, cGMP, and FDA submission support. As the leader of multiple program management teams, Kenny has led the successful completion of software, medical device, diagnostic assays, instrument, and companion diagnostic projects. He is recognized for his leadership, critical thinking, problem-solving skills, and navigation of external partnerships. Kenny brings a desire to generate, implement, and improve the efficiency and execution of the combination product programs.

Academic & Professional Qualifications:
  • M.S. in Emerging Infectious Diseases, Uniformed Services University
  • B.S. in Microbiology, University of California San Diego
Training, Quality Systems, & Specialties:
  • Medical Device Design and Development
  • Program Management
  • Design Controls
  • FDA, 21 CFR Part 820 for Medical Devices; Quality System Regulations
  • ISO 14971 Medical Devices – Risk Management
  • EN ISO 13485 & ISO 13485 Medical Devices Quality Management Systems
  • In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC
  • In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746
  • Clinical Laboratory Improvement Amendments of 1988 (CLIA) 42 CFR