Nate Mead [email protected] 6508 Devinney St Arvada, CO 80004 720-453-9319 SUMMARY Enthusiastic, driven, and team-oriented engineering manager with 16 years of experience in engineering management, general management, operations, manufacturing, engineering, medical devices, quality, and regulatory. Extensive expertise in both high-volume/low-mix and low-volume/high-mix environments, FDA regulations, ISO regulations, product and process validation, and verification Reduced manufacturing non-conformities by 15% to 50% annually every year for 6 years Rapidly promoted due to superior management skills: promoted or given additional responsibility every 2.6 years Among the youngest Senior Managers within the company; recruited by executive leadership in other business areas EDUCATION Colorado School of Mines B.S. in Mechanical Engineering Golden, CO 1994 to 1997 PROFESSIONAL EXPERIENCE Senior Manager of Engineering Lakewood, CO Terumo BCT (formerly Gambro BCT) 2013 to 2014 Manage direct engineering support of Class II medical device manufacturing operations, consisting of 20M subassemblies and 2M finished goods annually Direct reports included three engineering managers; total reports included three managers, 23 engineers, and 6 technicians Development and implementation of worldwide manufacturing strategies and plans Coordinate extensively with production management, operations, and quality to ensure smooth, high-quality product flow Extensive partnerships with R&D, providing manufacturing input and approval, and assisting in seamless integration into manufacturing operations Managed both outsourcing and insourcing or various products Trained and mentored Engineering Managers Manager of Engineering: Blood Bags, Subassemblies, and Finished Goods Lakewood, CO Terumo BCT (formerly Gambro BCT) 2008 to 2013 Manager of manufacturing engineer for 24/7 manufacture of 20M annual RF welded blood bags; direct reports included 7 engineers, several of whom are world-wide published experts of RF welding Transitioned to manager of manufacturing engineering for 24/7 production of blood bags, subassemblies, and finished goods in 2011; direct reports included 13 engineers Pioneered a Universal Engineering Support strategy directly resulting in fewer defects and significantly increased continuity between subassembly and final product assembly Reduced manufacturing non-conformities by 50% in one year Developed and successfully implemented continuous improvement program across all of manufacturing Managed significant supplier manufacturing issues, including successful recall & rework of 200,000 finished goods worth over $1M Managed project that single-handedly resulted in profit sharing for the entire company Trained and mentored Manufacturing Engineers Engineer 3 & Maintenance Supervisor Terumo BCT (formerly Gambro BCT) Lakewood, CO 2007 to 2008 Direct management of 18 maintenance technicians responsible for maintaining and continual running of machines of various types Successfully developed and implemented new manufacturing maintenance strategies, including formal escalation process and creation of new position to pioneer Total Productive Maintenance concepts at Terumo BCT Successful development of entire maintenance program of $4M automated bag assembly machine Engineer 2 – Manufacturing Engineer, Blood Bags Lakewood, CO Terumo BCT (formerly Gambro BCT) 2004 to 2007 Direct manufacturing engineering support of 24/7high-volume Class II medical device manufacturing operations Leader of two cross-functional teams that significantly improved both the safety and throughput capabilities of a $2M production machine Managed the relocation of an entire production area, including scheduling, validation of equipment, logistics, and management of technician, facilities, production, and vendor resources Developed extensive knowledge of RF, ultrasonic, and hot-plate welding; solvent bonding; automation and control systems; manual assembly; injection and blow molding; extrusion; process control testing Implemented and validated changes to various complex production equipment Streamlined production documentation, resulting in 40% fewer possibilities for entry errors Evaluated and determined disposition of suspect defective product Manufacturing Engineer – Cardiac Surgery Disposables COBE Cardiovascular Arvada, CO 11/2000 to 9/2004 Project manager for a cross-functional team that outsourced 90 subassemblies ($3M annually) to Mexico Leader of material review team responsible for disposition of non-conforming product Streamlined production processes by implementing and validating new equipment and eliminating inventory, saving $135K in daily inventory Performed all aspects of process validation on new and existing processes and equipment Verified over 30 disposable components and devices for use in finished assemblies Re-designed existing components for quality improvements and cost savings Supported day-to-day manufacturing issues for both in-house production and for contract manufacturer Authored manufacturing procedures and test protocols Quality Engineer – Cardiac Surgery Disposables Arvada, CO COBE Cardiovascular 5/2009 to 11/2000 Leader of CAPA (Corrective and Preventive Action) team and several process improvement teams, including solvent bonding, product labeling, complaint handling, and artificial aging Project leader for implementation of new complaint reporting software Evaluated customer complaints, including analysis of returned product, identification of root cause and quality trends, implementation of corrective action, and follow-up with customer and/or sales Provided technical support to customers and sales TRAINING Gambro BCT: Situational Leadership, Collaboration Skills, Blood School, Basic Machining Air Academy Associates: Design of Experiments, Statistical Methods, and Six Sigma University of Kentucky: Lean Manufacturing MAMTEC: Lean Manufacturing – Yellowbelt certified Humantech: Ergonomic Design Guidelines for Engineers Brigham and Women’s Hospital: Perfusion Techniques and Procedures PTC: Introduction to PRO/E
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