Randal Wallingford

Principal Quality Engineer @Bolt Medical

San Diego, CA, US
EMAILS
r••••••••@boltmed.com
MOBILE NUMBERS
+17•••••••39

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WORK HISTORY

Aug 2023 — Present

Principal Quality Engineer @Bolt Medical

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Carlsbad, CA, US

EDUCATION

1982 — 1988

California Polytechnic State University

BS MetE, Metallurgy

SKILLS

Research and Development (R&D)ValidationQuality SystemV&VFailure AnalysisQuality EngineeringMetallurgical EngineeringCatheter EngineeringGuidewire EngineeringProject ManagementQuality ControlProduct DevelopmentR&DDesign ControlFdaSupplier Quality EngineeringMedical DevicesMetallurgyScanning Electron MicroscopyHydrophilic CoatingsPtfe CoatingsCross-Functional Team LeadershipDesign of ExperimentsManufacturingVerification and Validation (V&V)Stent R&DIso 13485

ABOUT RANDAL WALLINGFORD

Senior Quality Engineering Consultant with MEDIcept• Principal Quality Engineer at ICU Medical for R&D and New Product Development• Lead Manufacturing Engineer for Medtronic responsible for the transfer of catheter manufacturing lines from an acquisition to the main facility in Irvine, CA• Sr. Quality Engineer with Johnson & Johnson DePuy Synthes responsible for creating New Product Development Design Control Process for the Veterinary Group, leading to ~50% savings in creation of new devices for veterinary use• Sr. Quality Engineer Responsible for the Vector Gait and Safety System at Bioness• Sr. Quality Engineer responsible for $150 million/annually self-expanding stent delivery system production at Abbott• Successfully launched two new generations of guidewires, including interfacing with FDA representative for Design Controls, rationales, protocols, and validations at Boston Scientific• Results-oriented Sr. Quality Engineer, Project Engineer/Manager with over 15 years of proven success in new product development at Johnson & Johnson, Abbott, Boston Scientific, and others • Hands-on Process Engineer and R&D Engineer for stents, catheters and other medical devices• Sr. Quality Engineer member of Regulatory Affairs advisory group evaluating documents for FDA submission• Designer of innovative processes that have saved companies millions of dollars each year• Inventor of two patented catheter technologies

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