David Mongin Email Address

Senior Program Manager

Immucor , Inc. is a Medical Devices store which offers Blood Bank Automation, Blood Bank Software Solutions, Molecular, and Transplantation Diagnostics.

I have been an integral part and technical leader on the development of a cervical cancer diagnostic device. My experience spans from the early prototype phase through algorithm training and pivotal trials for FDA and CE Mark filings through final engineering and transition to production. My roles have been as basic as building and testing the earlier prototypes to algorithm development to writing many of the top level engineering documents for CE Mark filings including Product Requirements Document, System Specifications, Hazards Analysis, System Verification and Compliance Test Procedures. I am also responsible for 5 out of 6 test stations used in production from initial designs through verification and calibration procedures. Technical expert on the development of a next generation laser porator for a large corporate client. I provided the oversight for the optical and mechanical designs within the team as well as coordination of the overall build and testing of the product. This redesign simplified the assembly, testing and use of the product and delivered a product that should be more reliable and free of virtually all maintenance issues of the previous generations. Conducted on slight audits of vendors, participated in vendor approval for production and negotiated prices for high and low volume production. Risk Management and ISO and FDA Compliance: I have co-lead the engineering team on several extensive Hazard's Analysis based on ISO 14971. These analysis were an integral part of the development of the Risk Management File along with an extensive Trace Matrix and System and Software Verification Process. I have been a lead contributor to the preparation and submission of a PMA Filing for a medical device that if approved will be the second device of it's type to be approved for diagnosing cervical cancer. Responsible for all customer complaints, PNR, CAPA and RMAs for LuViva product line.