Provided design assurance, trend analysis, and design integrity audits in support of stability testing for the globally recognized medical device company• Improved project visibility by leading a clinical stability protocol/report, hosting a biweekly meeting to discuss testing trends, creating graphs, noting existing lab deviations, and collaborating with a cross-functional design team for the IDE submission of a coronary drug-coated ballon product• Provided design assurance toward the… Show more Provided design assurance, trend analysis, and design integrity audits in support of stability testing for the globally recognized medical device company• Improved project visibility by leading a clinical stability protocol/report, hosting a biweekly meeting to discuss testing trends, creating graphs, noting existing lab deviations, and collaborating with a cross-functional design team for the IDE submission of a coronary drug-coated ballon product• Provided design assurance toward the stability testing of coronary drug-containing devices, including drug eluting stents and drug-coated ballons• Provided direct audit support on two BSI-notified body audits and an internal audit that supported CAPA reports• Coordinated with stability chamber supplier facilities to facilitate purchase orders and collaborated biweekly with Medtronic’s stability lab to track/organize non-conformances, deviations, and out-of-specification investigations• Researched/documented a chamber heating issue during a biannual preventative maintenance session by leading the event, communicating with chamber suppliers to schedule/plan the process and regulate all issues, identifying the heater issue, and determining the problem would not impede current testing.• Reviewed/created stability testing protocols and reports for annual, bridging, and clinical studies• Developed protocols for bridging studies between multiple departments for product changes, including packaging and sterilization site changes• Led monitoring activities of the stability chambers per ICH guidelines and managed quarterly environmental health/safety walkthroughs to ensure labs were following stated protocols• Revised equipment instructions for chambers to align with the Facilities department’s current methods and the chamber manual to guide the stability team through processes• Collaborated with cross-functional teams to advance each change through change order control and provided supplemental documentation of changes Show less

Contributed to quality control of new products within orthopedic devices for the medical device company• Oversaw coordination between product development and manufacturing engineers ensuring consistent performance and quality products• Managed/hosted pre-release product audits and functional audits on the product line prior to design review• Drove design review project completion when the CAD drafter was unavailable by leveraging existing knowledge of the project, a working… Show more Contributed to quality control of new products within orthopedic devices for the medical device company• Oversaw coordination between product development and manufacturing engineers ensuring consistent performance and quality products• Managed/hosted pre-release product audits and functional audits on the product line prior to design review• Drove design review project completion when the CAD drafter was unavailable by leveraging existing knowledge of the project, a working understanding of CAD design, and the organization’s drafting protocols to quickly/efficiently revise the multiple inspection drawings• Advanced functional audits/reports ensuring prompt delivery within design review timelines by leading a team of Quality, Marketing, Packaging, and Product Development engineers and a Product Management director through biweekly meetings to review updates/organization of products and coordinating with Product Development to facilitate the audits and help align the parts to simulate the surgical technique• Managed design control documents, including pFMEAs, operational micro process maps, gaging method plans, MSA reports, inspection method reviews, and design transfer plans• Created engineering change requests/orders to ensure high quality standards for new product inspection drawings, product specifications, and gages• Provided risk analysis and risk management documentation for ongoing projects• Performed process validation through process characterization studies/reports and performance qualifications• Facilitated primary production run inspections in a sterile environment and evaluated first articles of new products with Product Development and Manufacturing• Revised work instructions/visual standards for projects• Communicated gage designs to the metrology lab/suppliers for any custom gaging and gage calibrations Show less

Verified the sterility assurance level for medical devices of the global medical device company• Validated gamma and electron beam sterilized products through dose audits and ethylene oxide sterilized products by managing bioburden testing per product family• Provided direct audit support during a BSI-notified body audit and an internal audit• Provided reports of all sterility non-conformances and led CAPAs of clean room deviations resulting from audits• Managed the… Show more Verified the sterility assurance level for medical devices of the global medical device company• Validated gamma and electron beam sterilized products through dose audits and ethylene oxide sterilized products by managing bioburden testing per product family• Provided direct audit support during a BSI-notified body audit and an internal audit• Provided reports of all sterility non-conformances and led CAPAs of clean room deviations resulting from audits• Managed the production/distribution processes of sterile products: Gamma and electron beam batch releases of products with their documentation• Oversaw documentation/organization of environmentally controlled areas and performed monitoring of surfaces, viable/non-viable air in laboratory and clean room settings• Managed/presented monthly trends of identified microbes and their total aerobe counts to Wright’s Quality, Sterility Assurance, and Microbiology Management• Performed endotoxin testing of product samples/water lines, trained others, organized invoices/purchase orders for the Sterility Assurance department, and completed documentation needed for any non-conforming events Show less

Created assemblies, special parts, dimensioning, and shear jobs toward tubing and tubing actuation utilizing Inventor and AutoCAD• Engaged a Germany team to relay international engineering details• Analyzed drawings to create bills of material and discussed technical questions with customers involving pressure ratings, design recommendations, and value/actuator details

Provided customer service and delivery services for Domino’s Pizza downtown Memphis

Provided customer service and pharmaceutical organization

Supported the management and organization of the medical technology startup company• Designed a medical bracelet using CAD software (SolidWorks) and Sketchup as the Lead Mechanical Engineer• Interacted with fellow engineers, physicians, and computer scientists to better understand the mechanical/electrical needs for the bracelet