Test Method Validation Quality Engineer

Terrill D. Richardson

**** ********** ******, ******** *******, Colorado 80923

Phone: 219-***-**** E-mail: *******.**********@*****.*** Professional Profile

* ***** ** ******** ********** in the Bone Biology and Mechanics Lab (BBML) at Indiana University Purdue University Indianapolis

Experience in a high intensity contractor environment

Extensive experience using an Atomic Force Microscope (AFM)

Efficient at cell culturing, specifically fibroblasts and osteoblasts

Understanding of the FDA approval process for medical devices

Experience taking a medical device from idea conception to functional prototype

Adept at performing ethnography in a clinical setting Education

Purdue School of Engineering & Technology, Indiana University Purdue University Indianapolis, Indianapolis, Indiana (IUPUI)

Bachelor of Science in Biomedical Engineering Graduation: May 2014 John A. Swanson School of Engineering, University of Pittsburgh, Pittsburgh, Pennsylvania Master of Science in Bioengineering Graduation: May 2016 GPA: 3.45/4

Research Experience

Research Assistant - BBML

IUPUI February 2012-May 2014

Calibration of AFM

Determination of modulus through bulk mechanical testing and atomic force microscopy

Culturing and passaging of fibroblast and osteoblast cells

Treatment of cells to produce collagen matrices

Imaging and mechanical property determination of produced collagen matrix with AFM Skills

Quality Engineering: Creation and execution of a test method validation (TMV) protocol to find tool measurement uncertainty. Executing TMV testing, running statistics, report creation. Familiarity of running TMV on hand tools

(Caliper, micrometer, etc.), as well as, CMM such as SmartScopes.

Bioengineering: Handling deceased animals and harvesting musculoskeletal tissues, mechanical testing of biological materials, AFM, Preparing biomaterials, culturing cells, treatment of cells to produce collagen matrices.

Ethnography: Observing and interacting with groups in a clinical environment to identify problems and brainstorm solutions.

Prototyping: Taking observation from ethnography and creating a functioning prototype.

Software Packages: Excel, Word, PowerPoint, Publisher.

Statistical Software: Minitab, QC-Calc.

Monitoring Systems: QC-Calc, QC-Gage.

3D Design: CAD, Inventor, SolidWorks.

Professional: Organizational skills, leadership, outstanding time management, teamwork. Professional Experience

Spectranetics/Philips, Colorado Springs, CO

Temporary Test Method Validation (TMV) Quality Engineer August 2017 – Present

Help hire and construct a team to respond to an FDA warning letter.

Led a sub team of technicians to create documentation and run TMVs.

Trained new engineers to the companies GDP, systems, and how to create and execute a TMV.

Develop methods for test method validation of receiving inspection processes.

Write testing protocols to challenge inspection methods and find the measurement uncertainty.

Worked with technicians to create work instructions (i.e. personalized manuals) for the proper use of the tool.

Execute the testing protocol, with full ISO 17025 tractability.

Analyze the statistics to determine the repeatability and reproducibility of the test method.

Release a report with the minimum measureable tolerance for the tool based on the uncertainty. Empirical Testing Corp, Colorado Springs, CO

Test Engineer July 2016 – Jan 2017

Develop mechanical testing protocols for implantable medical devices.

Running test batteries according to ASTM standards.

Interpretation of mechanical test data.

Complete a report of the mechanical data for submission to the FDA. Best Buy, Valparaiso, IN

Geek Squad Agent 2008 – 2011

Member of a team that consistently made or exceeded budget every month

Initialized a training program to train new agents in how to reapir computers

Supported the computer sales department by solving customer issues and suggesting the best solutions

Responsible for tracking and reporting of department productivity

Initiated a process improvement project that resulted in reducing the repair turn around time from an average of 1 week to 2 days and improving customer satisfaction Office Depot, Valparaiso, IN

Sales Associate 2007 – 2008

Assisted with the setup and opening of a new store

Trained new employees on product knowledge

Presented computer equipment options to new and return customers ACS, Phoenix, AZ

Loan Processing Analyst 2006 – 2007

Reviewed students for eligibility to receive financial aid

Reported to Universities the amount of aid the student was qualified to receive

Data entry of loan packets

The Phoenix Zoo, Phoenix, AZ

Zoo Associate 2006 – 2006

Ambassador of the Zoo

Operated amusements to zoo visitor which included: rental of boats, operation of carousel and management of animal habitats

Responsible for the safety and security of all zoo visitors

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