Engineer Medical Device

Ziyan (Dennis) Chen

**** ********** ****, ********* ****, Lawrenceville GA 30044

Email: ******@******.*** Phone: 678-***-****

Objective

Seeking a R&D or Engineering position in the Medical Device Industry where I can utilize my education

and experience to participate in the ideation and development of robust, innovative, highly impactful

engineer solutions whose product realization solves complex real world challenges.

Education

BS, Biomedical Engineering, May 2011

Georgia Institute of Technology, Atlanta, GA

Professional Experience

Ecolab, Alpharetta, GA September 2013 to Present

Mechanical Engineer (6 Month Contract)

• Provide Project Management and Engineering leadership in the development and

remediation of Ecolab Surgical Helmet/Lens hood Product Lines; Responsible for all

design control activities.

• Set up various testing protocol, including Puncture Resistance, Strip Tensile, Liquid

Absorption Capacity, Strike-Through Time, Hydrostatic Pressure, etc, per relevant

ASTM/EDANA standard.

• Utilize Solidworks in the design of fixtures used in product testing and in-process

inspection.

• Evaluated the assembly of several injection molded parts, the effect of their Tolerance

Stack-Up, and assessed the force and stress of mated components.

• Participated and provided meaningful input in the ideation of Ecolab next generation OR

Fluid Warming System.

Femasys, Inc, Suwanee, GA, July 2012 to September 2013

(Designer, Inventor and Manufacturer of medical device dedicated for women’s healthcare)

Jr. R&D Engineer (Full Time)

• Responsible for the planning, organization and implementation of all design control activities, from

design input to regulatory approval and product commercialization, for new and revised Class II $

III medical devices.

• Created testing protocol, performed product verification testing utilizing instruments such as the

Instron Force Tester, PressureMAT (Leak Test) etc and composed report summarizing results.

• Utilized Solidworks in the design and modification of existing and new concept injection molded

components to meet specific design requirements. Responsible for creating and maintaining

drawings of Femasys products and components per ASME Y14.5-2009 standard.

• Designed (in Solidworks) fixtures and gauges utilized in product testing, incoming QC inspection

and manufacturing assembly.

• Conducted validation activities for new fixtures utilized in manufacturing and evaluated

Repeatability and Reproducibility for new gauges utilized in QC inspection per Measurement

System Analysis, Reference Manual, 4th edition.

• Utilized Statgraphics to perform statistical analysis (Methods include T-test, F-test, ANOVA,

Distribution Fitting, Tolerance Limits, Gage R&R, etc) on data obtained during product testing,

process, equipment and test method validation, etc.

Global Resources International, Inc, Flowery Branch, GA August 2011 to March 2012

(Contract Manufacturer and Distributor of products for the healthcare and industrial markets)

Project Engineer/Manager (Internship/Full-Time).

• Collaborated with oversea Chinese engineers in the contract manufacturing of various types of

drapes, gowns, tourniquets, surgical masks, tracheotomy tube holders, etc.

Related Skills

Software Skills

Software Proficiency Level Recent Usage Frequency

MS Word Proficient Daily, Very Frequently

MS Excel Highly Proficient Daily, Very Frequently

Solidworks Highly Proficient Daily, Very Frequently

Minitab Proficient Daily, Very Frequently

Statgraphics Highly Proficient Daily, Very Frequently

Instron / Bluehill Proficient Daily, Very Frequently

Labview Intermediate Rarely, Used Often in College

Matlab Intermediate Rarely, Used Often in College

PowerPoint Intermediate Rarely, Used Often in College

MS Project Intermediate Frequently, used to update project timeline

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