Joyce y Zhao
Director, Combination Product Medical Device @Takeda
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WORK HISTORY
Director, Combination Product Medical Device @Takeda
Combination product device development, design control, manufacturing, process validation, commercialization, life-cycle management, post-market surveillance, change control, complaint handling, continuous manufacuturing process development, risk management.
EDUCATION
University of Washington
Doctor of Philosophy - PhD, Mechanical Engineering
University of Washington
Ph.D, Mechanical Engineering
SKILLS
ABOUT JOYCE Y ZHAO
Medical device deign, development, manufacturing, commercialization, LCMMedical device manufacturingCross-functional leadershipRisk Management System (ISO13485, 21CFR820.30, MDR, etc.)Regulatory submission (FDA, EMA, PMDA, etc.)Post Market Surveillance (PMS)Design Control, V&V, Change Control, CAPAAutoinjectorPrefilled Syringe (PFS)large Volume Patch PumpDual-chamber Reconstitution systemNeedle-free jet injectorNasal Spray, InhalerBLA, NDA,aNDADesign History File (DHF)Project managementOrthodontic deviceNitinol shape memory alloyTechnical consultingFirst principle analytical modelingMatlab / SimulinkSix SigmaABAQUSSolidWorksMinitabJUMP
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