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

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

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.
• 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.
• 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

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.
• 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

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.
• 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.
• 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.
• 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○.
• 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.

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.

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.
• 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.

Master'S Degree, Materials Science & Engineering

Specialized in Polymers and Plastics Recycling

Bachelor'S Degree, Mathematics