Brian Dey Email & Phone Number

Gainesville, Florida, United States

● 22+ years of engineering experience, 18 focused on medical devices, and 12 at the senior level● SME responsible for all aspects of the design, purchasing, scheduling, manufacturing, quality, and release of surgical instrumentation sterilization cases following ISO 13485 and 17665, and AAMI ST79● Adept with ISO 11607-1 and -2 in designing both sterile and non-sterile packaging configurations, including inner and outer device containment systems, as well as external shipping and handling systems● Protocol and report creation experience for the qualification testing required to release both sterile and non-sterile packaging systems● Responsible for the certification of materials for use in medical devices, and meeting REACH, RoHS, EU MDR, and California Prop. 65 standards for these materials and medical devices ● Handled medical device packaging CAPAs and NCs related to EU MDR, for both sterile and non-sterile devices and packaging ● Created and ran company’s quality department, setting up from scratch a QMS and all related processes, and authored all documentation to allow the company to achieve ISO 9001 certification during my tenure● Organizational skills honed from managing as many as 15 multi-year-spanning projects simultaneously, each with variable scopes, fluctuating timelines, different outside manufacturing/suppliers, and changing priorities within the companies● Managerial experience overseeing three junior engineers during chemical processing facility installation and startup● Risk-management, testing, calibration, problem-solving, and troubleshooting skills● Solid mathematics background using statistical analysis to improve production● Experience with the design, prototyping, and testing of mechanical machines and devices● Extensive experience with materials selection, characterization, and implementation● Strong track record working independently/remote, as well as a significant leader and contributor to a multi-disciplinary project team

Memphis, Tennessee, United States

Responsible for integration, development, and support of packaging and instrument cases and trays for the newly acquired Medicrea division in Lyon, France using Agile software. Selected Accomplishments:● Designed, developed, and tested new Medicrea instrument case systems used for the protection, handling, and display of products● Remediated and Integrated legacy Medicrea instrument case systems into Medtronic Design History Files and Medtronic design esthetic● Coordinated and closed out sterile and non-sterile packaging non-conformances as part of EU MDR remediation using TrackWise software● Assisted with the development, documentation, and release of new mesh instrument baskets for Medicrea (mandated in the EU for cleanability purposes)● Developed new calculation tables for packaging forms related to perforation for cleaning and sterilization● Designed and prototyped a novel implant packaging system designed to allow surgeons to customize implant selection from across all released Medtronic and Medicrea fixation systems

Gainesville, Florida, United States

Responsible for creation of a brand-new company Quality Management System (QMS), maintenance of company compliance to both internal and external quality and regulatory standards, handling of all required regulatory submissions, and interaction with all customers concerning products and sales.Selected Accomplishments:● Planned, developed, and implemented QMS, including process development, documentation creation, records capturing, and maintenance of the system, including authoring of:○ Quality Manual○ All written procedures and work instructions○ Non-conformance Handling System○ Production waste record-keeping system to assist with increased cost savings○ Employee training system● Achieved ISO 9001:2015 certification for company with zero non-conformances or observations● Initiated and maintained active contact with all customers to keep them informed of new products, new product developments● Developed customer satisfaction survey to obtain customer feedback● Authored all required declarations and submission letters to regulatory agencies concerning RoHS, Prop 65, EU MDR, and EU REACH & CLP● Trained on and participated in all fiber production related activities for background necessary for QMS development, as well for a future management role in fiber production and new product development

Gainesville, Florida, United States

Responsible for the design and development of packaging for all non-sterile instruments, including sterilization trays, caddies, lids, latches, inserts, cases, and all associated reprocessing instructions. Selected Accomplishments:● Managed company instrument case designs○ Developed and released 433 designs for 75 new implant systems○ Tested and evaluated over 4000+ instruments● Developed and released custom instrument case designs for 10+ specific surgeons● Evaluated and consulted on the designs of over 275 custom instrument designs for specific surgeons● Developed and maintained all instrument case device Design History Files● Assembled a master reprocessing assessment catalog for all tested instruments to consolidate 100+ test reports into a single document for easier reference● Advised and consulted on instrument designs for cleanability and sterilizability with all Product Development Engineers● Developed and executed protocols for long-term reprocessing effects on instrumentation useful life● Responsible for the production of all instrument case device prints and quality documentation● Managed company UDI (unique device identifier) system project, investigating various permanent identification methods for all instrumentation per FDA requirement● Managed company GTIN (global trade item number) initiative, involving the planning, execution, and management of program to add new 14 digit number every instrument print and laser-marking of all new instrumentation● Managed company RFID implementation project, involving researching and picking all hardware tags for the tracking of all instrument cases● Mentored and trained new packaging engineer

Gainesville, Florida, United States

Responsible for the design and development of both sterile and non-sterile medical device packaging, including trays, pouches, sleeves, boxes, lids, inserts, cases, sterilization containers, caddies, and instructions for use. Selected Accomplishments:● Managed company instrument case designs○ Developed and released 216 designs for 39 new implant systems○ Tested and evaluated over 2000+ instruments● Assisted with company sterile packaging designs○ Developed and released configurations for over 100+ implants○ Tested and designed novel polyurethane sleeve for sterile packaging of pins, bits, and other sharp items using ISO 10993 and 11607● Developed the company’s instrument case validation process○ Revised entire packaging technical documentation format○ Implemented new transportation testing following ASTM D4169○ Created new specification documentation for use in quality inspections● Designed a modular instrument case system that was adopted for use by all business units ○ Cut instrument case component costs over 30%○ Allowed for sourcing from multiple suppliers, shortening delivery times○ Increased field support efficiency by having sharing of components across business units● Created a new Design History File for all instrument case components○ Removed burden for release from implant design engineers○ Increased documentation efficiency for regulatory requirements○ Cut instrument case component regulatory release time from 2 weeks to 1 day ● Developed and executed IQ/OQ/PQ for tray sealing machines● Created and managed company surface finish reference library for metal implantable materials ● Designed and released a novel interlocking instrument case system● Designed and released a novel overcenter pull lid latch that automatically clears itself to ease lid removal

Gainesville, Florida, United States

Responsible for the design and specification of both controls and mechanical systems for various R&D/Educational/Laboratory/Government projects. Selected Accomplishments:● Created a new controls design format that was adopted by the entire AEI Systems Integration Group● Assembled a Master Controls Library that organized all documents according to AEI’s Master Specification● Developed new project data calculation forms that were adopted by the AEI Mechanical Group● Designed a new controls symbology that increased the marketability of the AEI Systems Integration Group

Alachua, Florida, United States

Responsible for the design, installation, and operation of a production-scale polymer optical fiber manufacturing facility. Selected Accomplishments:● Supervised and assisted 3 junior engineers in the installation, testing, calibration, and troubleshooting of all process measurement, control, and production devices and systems● Authored HAZOPS reviews, safety manuals, and production operation manuals for facility● Oversaw fiber extrusion line, improving fiber transmission quality by over 110% through a rigorous experimental and problem-solving regime● Saved company over $250k through troubleshooting, modifying, and improving designs, equipment, and processes○ Developed novel method to continuously combine the raw materials necessary to make the fiber which eliminated possible runaway reactions, improved polymerization stability and fiber quality○ Created novel method for storage of uninhibited monomer so as to eliminate threat of runaway self-polymerization and possibility of explosion

Gainesville, Florida, United States

Responsible for the research, development, design, and testing of a novel polymer optical fiber, as well as its pilot-scale production facility. Selected Accomplishments:● Designed both pilot- and full-production facility’s process & instrumentation diagrams (P&ID), determined all necessary control loops, and specified/selected all required measurement, transport, storage, processing,a and production equipment and materials ● Conducted R&D projects critical to fiber production, including ○ Batch vs. continuous polymerization processes ○ Chemical/physical/environmental testing○ Vacuum distillation/purification experiments on monomer○ Fiber characterization via various microscopy, including SEM, EDS, and XPS○ Experiments with fiber post-production treatments to impart specific properties

Master'S Degree, Materials Science & Engineering

Specialized in Polymers and Plastics Recycling

Bachelor'S Degree, Mathematics