EDUCATION
2009 – 2011 University of Southern California
• Master of Science in Biomedical Engineering
2005 – 2009 Beijing University of Technology
• Bachelor of Science in Biological Science & Biotechnology
PROFESSIONAL EXPERIENCE
Aug 2011- Present Product Development/Manufacturing Engineer – United Biomedical Technology Inc., Monrovia, CA
• Applied broad biological and engineering principles to the development of dental implant devices and acted as the manufacturing lead (supervised 6 junior engineers)
• Trained as a facilitator for risk assessments (FMEA) on product/process and participated in design review, validation, and changes
• Prepared CE Marking regulatory applications to secure product approval in EU and prepared appropriate documentations for maintaining existing certifications (FDA, Health Canada)
• Maintained FDA QSR for products, sources, equipments and environment monitoring
• Participated in pre-production/post-production quality assurance projects, external audits for animal sourcing as well as pre-clinical testing programs with the QA group
• Reviewed manufacturing changes for compliance with ISO 13485 (Change Control)
• Created and revised manufacturing SOPs, investigated non-conformance reports, CAPA assessments, and assisted in both internal and external audits
• Evaluated and documented incoming product complaints and product analysis to determine MDR eligibility, complaint status and cause of events. Ensured the complaint files meet Quality System Regulation requirements and FDA requirements.
Feb 2012 – July 2012 Engineering Consultant – Biogennix, Irvine, CA
• Provided biomedical research and technical expertise for new product development
• Investigated the feasibility of combining collagen with osteoconductive macroporous granules as scaffold for a new implantable orthopedic product and developed a strategic plan for collaboration between two clients
• Identified and projected the financial costs for clients including sample preparation and testing
• Conducted experiments, performed data analysis, and prepared documents for 510(k) regulatory application
RESEARCH EXPERIENCE
June 2010 – June 2011 Research Associate – University of Southern California, Los Angeles, CA
• Supported the research of growth factor delivery via enzymatically cross-linked scaffolds
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