Chris Mitchell

APTG Consulting LLC | California

Freelance Contractor | April 2023 – Present

• Oversaw relocation project by transferring 49 of 60 customer machines, tooling, materials, fixtures, maintenance equipment, and work instructions between international facilities, achieving 60%+ of IQ, OQ, and PQ validations, training bilingual employees and creating documentation to support a smooth transfer of knowledge. 
• Negotiate favorable contracts with clients and vendors to secure mutually beneficial terms and financial success 
• Conduct thorough research to create international injection mold tooling standards documentation while onboarding new vendor resources and showcasing the effectiveness of updated tooling solutions for manufacturing consistency and vendor reliability
• Uncovered refinement areas and delivered process training for 15 team members in facilities HAZMAT, process equipment, tools, spares, and Meter Mix Machine operations, enhancing skills of a Liquid Resin Casting team

Cepheid | Lodi, CA

Staff Plastics Engineer / Technical Training Operations Leader, Plastics | March 2021 – April 2023

• Senior Staff Engineer, technical operations for 7 global contract manufacturers optimizing supply chain, manufacturing and automation processes, as well as documenting and training on polymer rheology to maintain product quality. Key member of the Cepheid Grassroots Safety Culture Team.  
• Led 50+ individuals in medical device and product development projects to foster overall productivity 
• Applied in-depth knowledge of critical business factors within biotech, medical device, and life science sectors to mitigate risks and align operations with industry standards including training production teams in proper documentation
• Certified an overseas supplier to meet company manufacturing and quality requirements while developing an end-to-end manufacturing cell in collaboration with supplier engineering and quality teams 
• Drove the formulation of vision detection systems for 18 complex clear PC diagnostic test cartridge component molds and molding machines in the U.S., Thailand, and China, to increase production accuracy and reduce defects
• Co-created a WIKI Page to allow Cepheid Teams and Contract Suppliers to access critical documentation for quick reference.  Drawings, work instructions, process documentation, quality processes, cleanroom procedures
• Played a key role in two Kaizen events by improving reagent cartridge uptime and eliminating runner ball waste, attaining annual cost savings exceeding $750k per initiative
• Analyzed inefficiencies and crafted 85+ Best Known Method manufacturing documents to guide internal teams and global injection molding suppliers in dozens of processes, quality, safety, tooling, automation, facilities and more. 

Westec Plastics | Livermore, CA

Technical Sales Engineer | March 2020 – January 2021

• Facilitated transitions between pre-sales and implementation phases by coordinating with project management teams
• Employed strategic prospecting to acquire a new client in 40 days and attain $50K within first-quarter revenue
• Reviewed RFQ packages to aid in creation of competitive quotes & engineering packages for securing new business

Lubrizol Specialty Products Inc. | Franklin, WI

Senior Project Engineer Implantable Silicone LIM | September 2016 – September 2019

• Led $750K, 2-year program, creating servo-driven, semi-automated manufacturing cell to punch up to 28 drain or sensor holes in in-house Lubrizol extruded silicone tubes with up to 4 lumens for neurological ventricular catheters
• Integrated advanced systems, including attribute-based vision systems for accept/reject analysis, semi-automated dimensional measurement fixtures using RAM Optical technology, and two silicone-over-silicone molding cells
• Supervised comprehensive program functions, encompassing 150K per quarter budgets, machine design, FAT acceptance, training, and quality oversight for seamless execution and sustainable performance 
• Spearheaded 17 distinct customer programs by coordinating sales team members to foster business growth 
• Advanced the formulation of a saline-inflated balloon system to support effective weight loss in thousands of patients
• Managed a $600,000 HCR molding program to design a plasma-charged vaginal balloon, achieving FDA approval with a non-invasive solution for cysts and polyps, while lowering reliance on partial and full hysterectomies
• Incorporated 6-panel and PSP methodologies to optimize efficiency of 3 high-value programs, worth over $1 million

APTG | Corona, CA

Contractor | September 2014 – September 2016

• Partnered with leading automotive clients, including Tesla, GM, Chrysler, and Fiat, to deliver engineering solutions
• Remapped plant's water system by redefining layouts, analyzing contractor bids, and employing targeted upgrades
• Headed 3 Senior Design Engineers in the US and Mexico while overseeing injection molding engineering projects for automotive switches, wire harnesses, and terminations, to drive tooling launches and resolve molding issues
• Governed the development and launch of a multi-tool Polycarbonate DNA Tape Test Cartridge, navigating issues in plastics, low power yields, and FDA audits, to bring the DNA testing program from pre-manufacturing stages into full-scale production. Trained manufacturing and customer teams in material analysis, SDS and Biohazard
• Addressed plastic molding defects and evaluated tooling designs at Edwards Life Sciences by deploying innovative solutions to minimize production downtime and support seamless integration through comprehensive documentation 
• Rectified a silicone cryogenic troubleshooting issue in the Heart Valve Delivery Systems program ahead of schedule by applying corrective actions, to trim defect rates and enhance delivery device components quality 

C. Brewer, Co. | Anaheim, CA

Program Manager | July 2011 – September 2014

• Handled the FDA-approved "Bubble Trap" program, incorporating advanced medical components and regulating compliance to resolve air bubble issues in blood transfer systems for heart surgeries
• Directed 24+ molding programs, involving horizontal machines, insert molding, and engineering-grade materials
• Controlled the Brevet fluid path program with 50 molds and interchangeable inserts, to aid in production of 200 SKUs 
• Built tool room storage system in conjunction with cross-functional teams, resulting in a 95% on-time delivery rate
• Automated the Oakley Sunglass Frame and Stem program in partnership with the automation team, introducing a polishing system to cut ergonomic strain and polishing time from over a minute to under 35 seconds per frame

US Navy | Global

Educational Services Officer | October 1993 – October 1998

• Decreased by 30% the number team members delinquent advancement qualifications
• Improved by 95% job specific personal qualification throughout the unit
• Received commendations for setting up a very successful and intensive program to teach over 365 Sea Cadets. 
• Developed distance learning for Naval Reserve units Nation Wide
• Consistently received tremendous praise on critiques from more than 180 students attending Naval Rights and Responsibilities workshops
• Earned Master Training Specialist for curriculum creation and training

Additional Experience

Toshiba Machine Co., America | District Sales & Applications Development

• Contributed to the creation of Liquid Silicone Molding and Metal Injection Molding capabilities at the Ontario, California Western Technical Center to expand regional sales revenue by over $3,000,000 in four years. Conducted countless industry seminars and training at MDM, Toshiba Tech Centers and Customer Facilities

Formula Plastics | Tooling Engineer Liaison

• Engineered and qualified 75+ molds/work cells for styrene thermoset, thermoplastic, and extrusion, to confirm FDA 510K compliance and meet validation standards in medical, aerospace, tech, and automotive sectors

Trend Technologies LLC | Senior Program Manager, San Diego State University | Adjunct Faculty 

United States Navy, USN | Chief Petty Officer.

Master of Arts in International Business Management, National University, La Jolla, CA

Bachelor of Science in Operations Management, National University, La Jolla, CA

Program Management, Fellow Academy | Master Program Manager AAPM | Master Quality Manager AAPM

Certified International Program Management AAPM | RJG Master Molder I & II | Master Training Specialist (USN)