Medical Device Quality Assurance

Shan He

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****W, ** Street 213-***-****

Los Angeles, California, 90007 **********@*****.***

Objective Seeking a Regulatory/Quality related full-time position in medical device industry after April 2014

Education University of Southern California, Los Angeles, CA Expected May 2014

Master of Biomedical Engineering, GPA: 3.7/4.0

Huazhong University of Science and Technology, Wuhan, China Jun 2012

Bachelor of Science in Biomedical Engineering, GPA: 3.6/4.0

Introduction to Medical Product Regulations ● Medical Device Regulation ● Quality Systems and Standards ●

Course List

Biomedical Measurement and Instrumentation ● Physiological Control System ● Signals and Systems Analysis

● Circuit Theory ● Digital Circuit & Logic Design ● Technology Development and Implementation

Coulter Program Intern at USC Stevens Center for Innovation, Los Angeles,US Feb 2014 –Apr 2014

Experience

Actively coordinate research teams, regulatory specialists and intellectual property attorneys for USC

Coulter Translational Research Partnership Program

Conduct market assessments and prepare detailed business feasibility studies for new medical technologies

Evaluate and develop business models and market penetration strategies

Regulatory Affairs/Quality Intern at Dental Evolutions Inc., Los Angeles, US Nov 2013-Dec 2013

Prepare documents for 510 (K) to the FDA of Class II medical devices

Communicate with manufacturing about dimension and materials of samples

Jun2013 – Aug 2013

Regulatory Affairs/Quality Assurance Intern at Stryker, Beijing City, China

Report adverse events to CFDA after researching the worldwide complaints from Stryker Quality System

Negotiate product testing with Technical Reviewers in Center for Medical Device Evaluation of China

Prepare documents for CFDA submissions and translate related FDA, ISO documents

Jul 2011–Aug 2011

Engineer Intern at Contec Medical Systems Inc., Qinhuangdao, China

Weld and test the analog circuit of Electrocardiography (ECG) integrated Printed Circuit Board (PCB)

Research Assistant in Biomaterials Lab of Department of BME, Wuhan, China Jun 2010-Jun 2012

Build Chitosan and Polycaprolactone Biological Catheter for nerve repair

Achieve tenacity and hollowness requirements of catheter

Project Mock 510K Premarket Notification Submission Oct 2013

Demonstrate substantial equivalence of Rectal Catheter to an existing marketed one

Utilize and follow associated FDA guidance and relevant standards (ISO) in labeling and testing

Evaluate potential risk and perform mitigation of the new product using risk management tools

Microsoft Office ● FDA ● Chinese SFDA ● 510(k) ● GMP ● CAPA ● ISO 13485 ● ISO 14971 ● 21 CFR 820

Skills

Solidworks ● Auto CAD ● C/C++ ● Matlab and Simulink ● 8086/51 assembly ● Verilog

Biomaterials and Tissue Engineering ● English and Mandarin Chinese

Honors National Scholarship for Encouragement (awarded to top 5% students) 2010-2011

Model Students of Excellent Academic Records (awarded to top 8% students) 2009-2010

Leadership University Dancing Team, Team Leader 2008-2012

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