Engineering Medical Device

Xiyu Chen

*****@*******.*** 607-***-**** www.linkedin.com/in/xiyuchen95 Saint Paul, Minnesota 55114 EDUCATION

Cornell University, NY Aug 2017- May 2018

Master of Engineering in Biomedical Engineering

Chung Yuan Christian University, Taiwan Sep 2013- Jun 2017 Bachelor of Science in Biomedical Engineering (Top 10%) EXPERIENCE

Zepto Life Technology, Saint Paul, Minnesota June 2019- Present Assay Development Scientist

• Developed immunoassays for cardiovascular and autoimmune diseases on the magnetic beads based microfluidic platform

• Evaluated and optimized assay in BSL2 laboratory and increased assay performance to meet customer needs

• Conducted competitor analysis for research use only products to identify a market niche and established product specifications

• Created and maintained SOPs, work instructions following ISO 13485 and 21CFR820

• Served as the R&D Liaison to software, hardware and mechanical teams for the supporting of product design

• Managed purchase and inventory with Infor visual ERP system U.S. China Innovation Alliance, Houston, Texas Dec 2018- June 2019 Program Coordinator (Innovation Investment Competition)

Implemented mail campaigns using Zoho, Mailchimp and Streak and successfully invited over 100 contestants to participate

Managed over 1000 partner profiles using Excel and checked with each monthly

Analyzed survey data and transformed results to improve the efficiency of marketing strategies

Worked closely with technical support to develop the company website and user interface MyBioGate Inc, Houston, Texas July 2018- Dec 2018

Medical Device Analyst Intern

Built a database through researching over 200 FDA approved medical products daily using Excel

Evaluated medical device companies based on patent landscape, market potential opportunities, and technical feasibility

Initiated contact with potential strategic partners, stimulated interest and negotiated terms for formal agreements PROJECTS

Respiration Monitoring Device for Non- ICU Patients Oct 2017- May 2018 Master of Engineering Capstone Project, Cornell University & Welch Allyn

Engineered a low-cost respiration monitoring device for Welch Allyn, Inc. that records respiration pattern using flexible sensor, accelerometer, gyroscope and Wi-Fi transmission

Generated 3D models of device and components for rapid prototyping using Fusion 360 and SolidWorks

Developed MATLAB code for sensitivity improvement and noise cancellation Anti- Inflammatory and Anti- Adhesion Material for Medical Application Oct 2016- May 2017 Undergraduate Thesis, Chung Yuan Christian University

Synthesized a thermo-sensitive gel using chitosan and β- glycerophosphate (β-GP) complex to avoid tissue adhesion after laparoscopic surgery

Characterized the mechanical properties of material to study how gel differs when exposes to various PH environment and shear forces

Designed spray container with a special nozzle for the purpose of storing and applying the product with advantage repeated use SKILLS

Programs: SolidWorks, Infor Visual ERP, JMP, SPSS, Microsoft Office Suite

Coding: Python, SQL, MATLAB, C++

• Lab skills: ELISA, Spectrophotometers, Human Serum, Immunoassay Analyzer, Ultrasonication, Lyophilization, Protein Microarray Slides, Biotinylation, Centrifugation, Western Blotting

Academic skills: FDA Regulations

Language: Mandarin Chinese (Native)

LEADERSHIP SKILLS AND ACTIVITIES

Activity Leader and Instructor: Chung Yuan Mainland Student Union May 2014- May 2015

Development of Technology, Creativity, Innovation and Entrepreneur Competition (1st place) Jun 2017

Biomedical Engineering Project Competition (1st place and Most Popular Award) May 2017

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