Experience

DCI Donor Services, Inc.

• United States
• Hospitals and Health Care
• 200 - 300 Employee

• Validation Engineer

  • Jul 2021 - Present

  · Responsible for validation projects with DCI Donor Services focusing on equipment, used in the storage and processing of donated human tissue. · Executed Installation Qualifications, Operational Qualifications, Performance Qualifications, and Supplemental Vendor Qualifications on new and existing equipment to include temperature mapping studies and process validations. · Authored Standard Operating Procedures for new Equipment and utilized a Document Management System (PolicyTech) to submit authored documents for collaborative adjustments, approval, and release. · Pioneered Validation project to acquire, validate, and implement a Kaye ValProbe Real-Time Data Logger System to replace legacy Data Logger System to extend the scope of temperature mapping capabilities. Show less



Cognate BioServices, a Charles River Company

• United States
• Biotechnology Research
• 1 - 100 Employee

• Validation Engineer

  • Aug 2020 - Jul 2021

  · Responsible for validation projects with Cognate BioServices focusing on equipment, facilities, and processes for GMP and in cleanroom environments. · Executed Installation Qualifications, Operational Qualifications, Performance Qualifications, Operational Requalifications, Commissioning Protocols, Cleanroom Smoke Studies, and Supplemental Vendor Qualifications. · Performed Quality Assurance Calibration Reviews through Blue Mountain Regulatory Asset Manager (BMRAM). · Utilized a Document Management System (MasterControl) to create and submit documents, including reports, records, and protocols, for collaborative adjustments, approval, and release. · Key team lead in a major project that involved authoring and executing Validation Qualification and Commissioning Protocols for a recently acquired warehouse facility along with associated equipment. The Validation Qualifications included temperature mapping of the warehouse facility and a walk-in cooler and freezer with Kaye Valprobe Data Loggers and Kaye Validator AVS system. · Qualified Trainer certified through a “Train the Trainer” program. Show less



Wright Medical

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Engineer

  • Sep 2019 - Jun 2020

  • Responsible for validation projects with Wright Medical focusing on equipment used for Quality Control, Research and Development, and in support of product release. • Validation of Quality Control Lab and Research and Development Lab equipment including authoring multiple forms of documentation to define User Requirements, Functional Specifications, Risk Assessments (FMEA), Intended Use and Base Risk Assessments, and Requirement Traceability Matrix. • Authored and executed Installation Qualification Protocols and Operational Qualification Protocols, and requisite reports required for client company approval and release. • Performed all validation activities in accordance with Global Quality Standard Operating Procedures for Computer Systems Validation. • Submitted all documentation through the Document Management System (Master Control) for collaborative adjustments, approval, and release. • Responsible for Validation Assessments of equipment and systems on an annual and biennial basis. • Key team participant in a major project to inspect Electron Beam Sterilization process and product packaging to ensure compliance to packaging and sterilization standards, and to identify any issues or nonconforming events. This project aided in major product release activities including a major increase in production rate. Show less



Cook Medical

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Remediation Engineer

  • Aug 2018 - Sep 2019

  • Worked on remediation project with Cook Medical focusing on the Cook Medical Ethylene Oxide Sterilization Facility. • Remediation of sterilization chamber and ancillary equipment involved authoring multiple forms of documentation to properly classify sterilization equipment, establish inspection procedures, assess suitability of the equipment for the process, calibrate the equipment and create calibration procedures, and to establish preventative maintenance requirements. Authored Component Criticality Assessment documents for the sterilization chamber and respective equipment. • Validation activities include qualifying equipment used in the sterilization process by developing and executing Installation, Software, Operational, Process, and Tooling Qualifications according to established procedures. • Utilized AutoCAD to develop facility P&ID (Process and Instrumentation Diagram) drawings for each sterilization chamber including all equipment and piping. • Studied, applied, and gained proficiency in practical understanding of Ethylene Oxide Sterilization methods and procedures utilizing Cook Medical proprietary sterilization equipment. • Interacted with Sterility Assurance team to understand ETO Sterilization process and how the cycles are tested with regards to bioburden and dunnage as a part of the qualification process. Show less



Arkis BioSciences

• Knoxville, Tennessee

• Biomedical Engineering Intern

  • Aug 2017 - Jul 2018

  Medical Device Research and Development to Treat Hydrocephalus • Designed, developed, prototyped, and tested a wide range of catheter products (Class I Medical Devices), tunneling devices and accessories (Class II Medical Devices), and tooling apparatus. Products include the recently released CerebroFlo™ EVD Catheter, Single Pass Tunneling Guidewire®, Subcutaneous Guidewire™, and other proprietary product projects still under development. • Optimized laboratory equipment used for manufacturing and testing products by performing a structural analysis and subsequent redesign in Solidworks. • Researched and implemented a Geneva Wheel mechanism to replace a legacy pneumatic tool indexing mechanism to address production issues at a partner manufacturer. • Designed medical device prototypes, models, and assemblies according to design objectives received from a surgeon and other engineers for performance, cost, and reliability. Designs included consideration for manufacturing processes like injection molding, milling, and 3D printing (polymer extrusion and stereolithography). Performed part design and modeling with Solidworks and made 3D printed prototypes. • Solidworks used to design custom testing apparatus for prototype testing in accordance to Verification and Validation protocols. • Tested Arkis products in accordance with ASTM and Arkis standards. • Developed process and documentation for manufacturing products, cleaning manufactured products, and testing manufactured products. • Conduct and participate in design review meetings. • Benchmark testing and evaluation of competitive medical device products. • Write verification and validation protocols and reports. • Interpret and document design inputs, develop and design response outputs, and refine design output through prototype development, and through performance and validation testing. • Prepared samples for dose audit for gamma ray sterilization according to facility and company standards. Show less



University of Tennessee, Knoxville

• United States
• Higher Education
• 700 & Above Employee

• Graduate Research And Teaching Assistant

  • Aug 2016 - Jul 2017

  EcoCAR3 (GM Sponsored Hybrid Camaro) • Graduate Teaching Assistant under Dr. David Irick for Mechanical Engineering Design I/II and MABE (Mechanical Aerospace Biomedical Engineering) Senior Design. • Graduate Research Assistant / Systems Modeling and Simulation (SMS) Team Leader responsible for modeling, simulating operation, and testing of vehicle supervisory controller through test case development, and directing issue mitigation activity by the Controls Team. • Focused use of Simulink (modeling interface), MATLAB, and dSPACE (simulator and interface) for test case development, software-in-the-loop (SIL), and hardware-in-the-loop (HIL) simulations. Show less



Tenntak LLC

• Seymour, TN

• Chief Referee and Staff Supervisor

  • Aug 2015 - Aug 2016

  • Relied on excellent verbal and written communication skills and integrity to allow for an energetic and friendly environment for both the customers and staff, resolving conflict as needed. • Used Solidworks to design accessories and print 3D PLA parts (on personal printer) as an alternative to metal counterparts without sacrificing functionality and allowing for customization (primarily a hobby, but sold a few.) • Relied on excellent verbal and written communication skills and integrity to allow for an energetic and friendly environment for both the customers and staff, resolving conflict as needed. • Used Solidworks to design accessories and print 3D PLA parts (on personal printer) as an alternative to metal counterparts without sacrificing functionality and allowing for customization (primarily a hobby, but sold a few.)



Fiberweb

• Textile Manufacturing
• 100 - 200 Employee

• Co-op Student Engineer in Quality Department

  • May 2013 - Dec 2013

  Manufacturer of Non-Woven Polymer Fabrics • Tasked to reduce variability and improve accuracy of test and inspection equipment, and validate via gage repeatability and reproducibility tests. • Designed and introduced an optical inspection system to replace the legacy manual system to inspect proprietary non-woven fabric conformance to industry standards. Developed and tested prototype core vision system to support proposal for funding approval to complete project. • Collaborated with outside vendors and conducted internal meetings, including with upper management, to present concept proof and proposal for completing the project. • Employed statistical analysis of measured variability and corrective action results via Minitab. Show less