Fremont, California, United States
• Over 20 years of extensive experience in medical device research and development. • Specializes in medical device design control, quality assurance, and regulatory compliance.. • Thorough understanding of medical product development process and design control under strict FDA and international regulations (ISO 13485, 14971, IEC 60601, 62366, 62304, CFR 820, etc). • Strong ability in planning, organizing, and prioritizing multiple projects and working on a multidisciplinary team as well as independently. • Excellent management, interpersonal, and written/oral communication skills. • Solid knowledge in risk assessment, design verification, and statistical analysis. • Strong background and versatile hands-on skills in a variety of analytical techniques and methodologies.
• Lead a research and development team for development of an advanced wearable medical device; • Responsible for design control and all technical matters in R&D and manufacturing activities in the company. • Establish a quality management system in compliance with ISO and Chinese regulations for the company as a medical device developer and manufacturer; • Guide the application for Chinese and European marketing approval of company’s medical devices.
• Remediate DHF for on-market dialysis machines and supporting accessories to be in compliance with regulations; • Create user requirements, system/subsystem design requirements, V&V documents and other DHF deliverables. • Serve as Project manager, maintain traceability matrix, and perform internal audit.
• Remediate DHF for on-market combination drug delivery devices to be in compliance with regulations; • Perform risk assessment; create user requirements, design architecture, system/subsystem design requirements • Create and maintain traceability matrix; and lead reviews through a multi-functional team for document approval. • Participate in root cause analysis for CAPA projects and implementation of FDA UDI system.
• Generate system requirements, conduct risk assessment, user interface assessment, and multi-functional review meetings. Maintain document control and traceability for both hardware and embedded software. • Develop / execute protocols and prepared reports for system verification and validation. • Establish test fixtures / methods and characterize the system for its performance, functionality, and reliability. • Investigate new designs and prototypes of sensor structures and functions with extruded conductive polymer materials. • Engage in algorithm development, optimization, and implementation. • Have eight patents granted.
• Lead the analytical function for the investigation of noninvasive drug delivery to the back of eye via animal models using HPLC and radioactive makers.