Team

Allen Lee

Consultant

Allen Lee is a leader with experience in technology/product development and multi-disciplinary engineering team development. He has a strong background in developing innovative & quality products in the high tech industries with highly regulated environment. In addition to providing technical guidance and engineering leadership focusing on how to design and manage new product development over their life cycles for clinical and commercial medical devices, combination products & drug delivery systems, Allen has successfully established essential engineering departments by recruiting, coaching, developing, and motivating an engineering team.

Academic & Professional Qualifications:
  • BS, Electrical Engineering, University of California, Santa Barbara
  • Postgraduate study, Electrical Engineering, California State University, Long Beach
Training, Quality Systems, & Specialties:
  • ISO 13485
  • ISO 14971
  • Feasibility studies / concept design / system platform/architecture / market research / risk management / human factors / regulatory
  • Conform to quality standards such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Quality System Regulations, ISO standards, etc.