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His manufacturing experience comes from the design and management of the Ultrasound Imaging Systems Instrument and Systems productions processes. His responsibilities included managing the budgets, resources, new product introductions, assembly and test operations and product support over the entire life cycle of the products. He helped develop and implement the HP Medical Product Group's Quality System for the multi divisional and international HP Medical Products Group. A significant portion of his quality systems experience consists of interpreting and implementing the Quality System Regulation for current Good Manufacturing Practice (21 CFR Part 820) including Design Controls, Records, Production and Process Controls and CAPA. He also developed the compliance plan for the Electronic Record and Electronic Signature regulation 21 CFR Part 11 and was chosen to lead the validation oversight of a worldwide installation of SAP 4.6c ERP systems for the Philips Cardiac Monitoring Systems group.
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Mr. Hillenberg is the principal and founder of cGMP Services and is experienced in medical device design, manufacture, and quality systems. His tenure with the Philips Cardiac Monitoring System, Agilent Health Care Systems and Hewlett Packard Medical Products Group consisted of contributing as an individual contributor, project manager, production manager and new product technical manager. He was part of the team that designed,developed and manufactured Hewlett Packard's first Ultrasound Imaging System providing several hundred million dollars in revenue annually.