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Ziyan (Dennis) Chen

1950 Roswell Road, Marietta, GA, 30068

Email: ziyandennischen@gmail.com Phone: 678 779 8164
Seeking a highly challenging design engineering position with a focused on developing sophisticated mechanical
and/or electro-mechanical systems using both analytical model-based design approaches as well as practical
prototyping to generate impactful and effective design solutions.

To be the person in charge of defining, dissecting, strategizing, and executing the product-based resolutions for
seemingly impossible problems within the medical device field.

BS, Biomedical Engineering, 2011
Georgia Institute of Technology, Atlanta, GA

Skill and Experience Summary

Below is the summary of experience within the context design excellence (DMADVV) and design control

Product Development Highlight: Development and Launch of multiple components,

5+ Years systems and products. Created several Design History Files.
Experience Managed DFM, DFA, Risk Assessment of development projects

Highlight: Developed a highly sophisticated predictive

Product Design/Research Mathematical Model for a complex lockout mechanism (58 input
5+ Years variables to performance prediction) to optimize and accelerate
Experience design. Work was published in 24,000 words study and resulted
in a functional tool that others could use.

Product Testing Highlight: Managed an instron test lab, developed dozens of test
5+ Years methods, including test method validation, also set up various
Experience mechanical testing during product development

Product/Component Name Company Define Measure Analyze Design Verify Validate

Fem Chec Mini / FemVue Femasys
Universal Lens Hood Ecolab
Zimmer Natural Nails and
Mathematical Models - Powered
Endocutters Lockout Mechanism
Yoke and Handle Shrouds-ETS 45
Endocutters (articulating)
Distal Channel Retainers - Echelon
Vertical Grip Persuader/Mono-Axial
Screws/Illiac Screws

Vertebral Body De-rotation System Amendia

Highly proficient with below Design-Related Tools
Solidworks NX Unigraphics GD&T DFMEAs Monte Carlo Simulation

Six-Sigma Tolerance Stackup Analysis 1D Enventive (2D T-stack) 2D vector Diagrams (2D T-stack)

Root Cause Analysis

VIS-VSA (3D T-stack) (KT, Fishbones, 5- AFMEAs DOEs

Proficient with below Process/Quality Related Tools

Gage R&R Gage Linearity Study SPCs Process Capability Assessment

OQ - Process PQ- Process Variable Sampling

Attribute Sampling Plans
Validation Validation Plans

Monte Carlo Geomagic Control

Functional Gauging

Highly proficient with below Verification/Validation Tools

Cadaver Lab
Instron - Static Axial Instron - Torsional Instron - Dynamic Fatigue Fixture Development

Statistically Analysis Using Minitab (T-test, F-test, Power Analysis, Capability, Reliability Study Test Method
DOEs, Chi-square Test, Distribution fitting, etc) (Reliasoft+) Development

Other note-worthy skills

Excel Spreadsheet Master - created multiple excel-based tools to aid team activity management, project
management, time management, inventory tracking, resource management, compatibility matrix, requirement
work-book, etc

Work History
Amendia / Spinal Elements | Atlanta, GA February 2017 to Present
Sr. Product Development Engineer
Lead Design Engineer for the Vertebral Body Derotation Systems for open, hybrid and MIS approaches.
Conducted detailed surgeon interviews to establish specific and quantitative user and product level
design targets, and created functional prototypes including a segmental reduction/clip on device, a de-
rotation rack system as well as other modular connecting pieces.
Designed (solidworks) and Developed Vertical Grip Persuaders, Mono-Axial Screws, Uni-Planar Screws
and other Complex Spine Posterior Fixation implant and Instrumentation systems.

Johnson and Johnson | Warsaw, Indiana and Cincinnati, Ohio April 2015 to Nov 2016
Design Engineer
Created a large scale predictive mathematical model, through the establishment of seven sets of
transfer functions, for a highly complex lockout mechanism that correlated 58 different feature
dimensions to a single performance.
o Conducted dozens of Six Sigma based Tolerance Stack-up analysis in 1D based upon basic vector
o Conducted 2D T-stacks utilizing a self-invented technique within NX and created overall transfer
functions associated with the mechanical systems in 2D
o Created two large scale FEA based Design of Experiments (Fractional Factorial, Full and
Response Surface) based upon prescribed loading conditions associated with the mechanical
system and created transfer functions associated with the deflection, bending and overall
nodal translations of critical features.
o Created a probabilistic mathematical model within excel, based upon Monte Carllo simulation
tools @risk, to predict the impact of input dimension changes to a change in performance.
o Created Parato Chart of ranking 58 input feature dimensions, conducted investigations and
utilized the model to generate both corrective and preventative actions to close the CAPA.
Utilized above mathematical model in the development and optimization of several component designs
specifications based upon predicted output performance of different design iterations.
Designed a mechanical test fixture to establish the product performance requirement associated the
lockout mechanism (features are hidden and thus not easily assessed)
Implemented several injections molded components as part of the tooling refurbishment efforts.
Coordinated mold flow simulation (Sigma Soft) to evaluate warpage, knit lines and ensure overall design
Conducted Finite Element Analysis to assess the impact of Datum Profile on Force to Close. Establish an
overall Datum profile tolerance requirement for Platform Endocutter Closure Yoke associated with the
force to close.

Zimmer | Trauma, Warsaw, Indiana March 2014 to April 2015

(1-year Contract) Product Development Engineer
Participate in a cross functional team to remediate/redesign Zimmer Antegrade Femoral, Tibial,
Retrograde Femoral, and Cephalomedullary Intramedullary Nail implants and instrumentation.
Performed Tolerance Stack-Up analysis to evaluate the functional relationship of Zimmer IM Nail
implants and instruments.
Conducted feature based design assessment, generated test protocols and test reports based upon
additional verification requirements.

Ecolab, Alpharetta, GA September 2013 to March 2014

(6-month Contract) Mechanical Engineer
Developed and successfully launched Ecolab's Surgical Helmet/Disposable Lens Hood product.
Utilize Solidworks in the design of fixtures used in product testing and manufacturing in-process
inspection. Fixtures include puncture resistance test fixture and tab-bump inspection fixture.
Researched relevant ASTM/WSP test standards and set up various test methods including Puncture
Resistance, Strip Tensile, Liquid Absorption Capacity, Strike-Through Time, and Hydrostatic Pressure.

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

Jr R&D Engineer
Successfully developed Femasys Pressure Management Device (FemChec mini) and Saline-Air Delivery
Systems (Fem-Vue) from late development phase through design verification testing phase to product
Designed (in Solidworks) injection molded components, testing fixtures and gauges.
Created testing protocol, performed product verification testing utilizing Instrons, designed customized
fixtures, analyzed test data with Statgraphics and composed reports summarizing results.