•Worked with clients and multifunctional groups to identify problems and generate solutions to meet deadlines and expectations. • Generated IOPQ, and Process Verification protocols for sterile barrier packaging according to EN 868-5, EN ISO 11607-1, EN ISO 11607-2, ASTM F88, ASTM F1929, ASTM F3039, ASTM F2096, and ASTM F1886.•Authored and generated computer system validation (CSV) documentation for datalogging equipment/software and troubleshoot complex IT related issues with the software.•Coordinated the timeline and movement of product for multi-thousand dollar testing that utilized Ethelyene Oxide sterilization and external vendors for testing.• Utilized Kaye AVS for the execution of temperature mapping of freezers, fridges and other cold storage units. • Generated equipment documentation, and execution protocols for label printers, barcode scanners, and barcode verifiers for 1D barcodes to ISO/IEC 15416 and ISO/IEC 15426-1• Authored and executed engineering studies and reports of parameter settings for heat sealers utilized in sealing primary and secondary sterile packaging. • Executed validations and worked in ISO 7 and 8 cleanroom settings.• Performed commissioning of laboratory spaces and laboratory equipment (water baths, fume hoods, BSCs, cell counter, flow cytometry, plate washer, etc.)• Generated equipment requirement documentation, for facility equipment such as compressed air systems, fleshing machines, and USP water systems.• Assisted and led professionals in the determination of appropriate pathways to complete documentation and assessment of existing equipment.

• Ensured Quality System compliance to FDA 21 CFR 820, ISO 13485, and ISO 14971.• Updated and created SOPs, work instructions and forms to streamline processes and documentation • Complied medical device studies, complaints, and clinical data for post-market surveillance for 12 products currently out in the field.• Managed new product development for multiple projects & led design control meetings with cross-functional teams of new designs to be released on the market.• Authored and created Clinical Evaluation Reports to follow European Guidelines and Regulations (MDR & MEDDEV).• Executed protocols for label printers with 2D barcodes to ISO/IEC 15426-2, and ISO/IEC 15415.• Generated control plans, process flowcharts, FMEAs and pFMEAs to identify issues and to streamline the manufacturing process.• Performed internal quality audits and walkthroughs of the manufacturing floor and internal documentation per ISO 13485 and FDA 21 CFR 820.• Authored IQ, PQ, OQ, POQ, PPQ, S/W validation protocols, and reports for equipment such as SWISS Lathe, HAAS Mills, 3D Printers, Passivator, and additional manufacturing processes.• Authored protocols/reports and performed cleaning monitoring testing for metallic, PEEK, 3D implants, and instruments to ANSI/AAM ST72, ISO 19227, ISO 10993-5, and ASTM F3127.• Worked with external vendors to manage calibration certs, schedule calibrations for all of the company’s micrometers, calipers, thread gages, CMMs, vision systems, and other calibrated equipment.

As a Development Engineer on contract at Zimmer Biomet I am doing documentation revision to bring products to current ISO/ASTM standards and performing product lifestyle engineering in the Foot and Ankle department. I am gaining a further understanding of implantation techniques as well as the ability to comprehensively understand CAD drawings and GD&T. I work closely with other engineers to create trace-ability and share-ability between our products within the company. I have done statistical and data analysis of testing data that were performed. I also do post market activities for existing design history files for implants associated with my department.

As an assistant to my boss, he would have me work under him as an apprentice to learn the trade of purifying the shortening oil and cleaning the deep fryers as efficiently as possible. Once trained to a certain caliber, I was able to take over the business and work by myself in order to relieve my boss for some personal time. Operating the filtration unit, the industrial-powered vacuum, and using my communication skills to better affiliate myself with the work environment of the University of Toledo and local restaurants around the greater Toledo area.

I set up meetings to discuss topics that were related to what the objective of the day was. I also set up laboratory experiments that were to be conducted. My other tasks included setting up temperature monitoring devices around the building in order to be able to accurately determine the temperature and humidity in the building throughout the day and night. I have managed equipment organization as well as the calibration records for all the equipment in my building