Luat Nguyen
Sr Systems Integration Architect @Heartstream
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WORK HISTORY
Sr Systems Integration Architect @Heartstream
Bothell, WA, US
EDUCATION
University of Washington
Bachelor of Science (B.S.), Electrical Engineering, Robotics and Controls
SKILLS
ABOUT LUAT NGUYEN
19+years’ experience in Class II 510k and Class (PMA) Medical Device product development, sustaining, and manufacturing. 10+years’ experience leading electrical and mechanical engineering teams and projects.Develope a high performance and highly motivated team.Experience in Systems hardware/software Integration, Circuit Design, Test System Design, End of Life Component Redesign, Quality, Operations, Product Development, Cost Saving, and Global Supply Chain.Expertise in Process Validation, Safety Risk Assessment (SRA), dFMEA/pFMEA, APQP, DFx, Reliability and Statistic.Champion for Root Cause Analysis and implementing Corrective and Preventive Actions (CAPA).Extensive product knowledge of manufacturing processes and manufacturing materials. Experience in data mining to support issue investigation, monitoring production and field data to identify areas that need attention.Experience working with and managing supplier commodities on a global scale.Experience in the evaluation, selection, and development of new suppliers.Experience in FDA Regulations CFR 820, ISO 13485, EU MDR, 510k and PMA.Experience in IEC standards
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