Kordell Tan

Professionally licensed engineer (CA) with extremely diverse experience in the medical device space, including full scope medical device development, managing feasibility studies, requirements definition, risk assessment, design verification and validation activities, manufacturing transfer, and market release. Previous experience includes: catheter design, drainage assembly design, sterilization validation, packaging design and validation, IQ/OQ/PQ manufacturing equipment validation, generation of manufacturing documentation (batch record and work instructions), creation of standard operating procedures, and human factors and usability engineering assessment.