Quality Engineering

Miyuan Xu 323-***-****●************@*****.***● linkedin.com/in/miyuan-xu

SUMMARY

M. S. in Biomedical Engineering. Experienced in Quality Engineering and Data Analytics. Lean Six Sigma Green Belt. Working knowledge of 21CFR 820, ISO 13485, ISO 14971, ISO 9001, cGMP, Risk Management. Hands-on skills in Statistics, Technical Writing and Project Management. Skills in SolidWorks, MATLAB, JMP, Minitab, MySQL. Quick learner, self-motivated, and a proven leader. Actively seeking engineering opportunities in medical device field. EDUCATION

University of Southern California, Los Angeles, CA 08/16 – 05/18 M.S., Biomedical Engineering, Emphasis: Medical Device & Diagnostic Engineering, USC Viterbi Master’s Award Shandong University, Jinan, China 09/12 – 06/16

B. Eng, Biomedical Engineering (Honors Program), Emphasis: Electrical Engineering, Best Thesis Award Hanyang University, Seoul, Korea 03/15 – 08/15

International Exchange, BioNano Engineering, Emphasis: Biomaterial, Outstanding Scholarship Tianjin University, Tianjin, China 09/13 – 06/14

Domestic Exchange, Biomedical Engineering, Emphasis: Electrical Engineering, Outstanding Scholarship WORK EXPERIENCE

12/17 – 03/18 Medtronic, Shanghai, China

Restorative Therapies Group, Neurovascular R&D, R&D Project Intern

• Trained in Design Control to gather Design Inputs and Design Outputs for NV embolization devices

• Executed bench testing, feasibility testing, friction testing and tensile testing to evaluate coil design tools

• Designed Tooling & Fixturing for special inspections and wrote test protocols to comply with ISO 13485

• Updated Design History File using Agile and Enovia PLM and reviewed engineering reports (RMW)

• Participated in Gage R&R and DOE studies and analyzed data using Statistical Process Control charts

• Troubleshot manufacturing non-conformance issue for critical product lines and trained in ISO 14971 12/17 – 03/18 Thermo Fisher Scientific, Shanghai, China E-business Department, Data Analytics Intern

• Extracted data from TMO database using MySQL and proposed solutions for non-dealer’s market share

• Performed 2018 Q1 Web Integrated Marketing Campaign for new product launch using Adobe Analytics

• Worked with cross-functional teams to assist customer behavior research for various product lines 05/17 – 08/17 USC Coulter Program, Los Angeles, CA Regulatory Affairs Intern

• Complied materials of IDE and 510(k) draft for Class II medical device under product code JXG

• Searched CRDH, MDD, MDR, and quotes for biocompatibility tests, bench testing, and clinical testing 06/15 – 08/15 Hanyang University, Ansan, Korea

BioMEMS Lab, Research Intern

• Fabricated microfluidic wafers using PDMS and plotted associated layout using SolidWorks

• Designed schematic diagram in LabVIEW for BioMEMS and optimized operation condition by 25% 2013 – 2014 Samsung Electro-Mechanics Co., Ltd., Tianjin, China Manufacturing Department, Intern Associate

• Troubleshot non-conforming electricity burning issue to support manufacturing process development

• Communicated with cross-functional teams to achieve organizational goals during product lifecycle PROJECT

01/17 – 12/17 Engineering Project Management, Quality Management

• Applied QMS frameworks on strategic planning, process management, and performance measurements

• Carried out FMEA, V&V, Design Review, and QFD to meet lean manufacturing under ISO 9001:2008 01/17 – 05/17 Standard Operating Procedure (SOP) Writing, Corrective And Preventive Actions (CAPA)

• Prepared an SOP to incorporate QSR and executed implementation and verification of CAPA

• Identified and investigated root cause of Class II device recall using Fishbone Diagram and 5 Whys

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