TECHNOLOGY TRANSFER

Led project to transfer an acquired medical device business, including manufacturing process and engineering design knowledge and specifications. Dellshire project management and engineering services were leveraged to insure performance to schedule and overall timeline.  Pilot build start up was completed on-time five months from start and subsequently released to the field.  Portfolio included 2 instruments and 30 disposable and electronic kits. Impact areas: Design History File (DHF), Operations, ERP, V&V, Quality Systems (QS), Regulatory Affairs/Quality Assurance (RA/QA), Supplier Management, embedded software remediation, complaint handling.