Senior Software Quality Engineer at Glidewell Dental
Aliso Viejo, California, United States
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Summary
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Senior
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Brian Hsu is a Senior Software Quality Engineer with 14 years of experience specializing in medical device software, R&D, and quality systems for healthcare products. He combines hands-on embedded and mobile development (C#, Android, TCP/USB, OpenCV) with deep expertise in ISO 13485, FDA SaMD guidance, IEC 62304, and traceable Agile testing practices. Brian has led cross‑functional teams through 510(k) renewals, cost reduction in manufacturing, and HL7 integrations for hospital EMR projects, bridging product, production, and customer operations. His background at ITRI includes real‑time ultrasound apps and ML-based image classification, giving him a rare mix of clinical‑grade software engineering and regulatory program management. Based in Aliso Viejo, CA, he’s known for translating complex technical requirements into auditable processes and for stepping into technical gaps to keep projects on schedule.
14 years of coding experience
14 years of employment as a software developer
Master of Engineering (M.Eng.), Electrical and Electronics Engineering, 4.13, Master of Engineering (M.Eng.), Electrical and Electronics Engineering, 4.13 at National Chung Cheng University
Contributions:183 commits, 1 push in 2 years 1 month
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Brian Hsu - Senior Software Quality Engineer at Glidewell Dental