Luan Truong

Sr Manager Quality Complaints @Amgen

Los Angeles, CA, US
EMAILS
l••••••••@amgen.com
MOBILE NUMBERS
+18•••••••91

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WORK HISTORY

Jul 2024 — Present

Sr Manager Quality Complaints @Amgen

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EDUCATION

2002 — 2006

California State University, Northridge

B.S, Mechanical Engineering

2006 — 2008

California State University, Northridge

M.S., Mechanical Engineering

SKILLS

Project ManagementSolidworksTechnical LeadershipStatisticsR&DFdaContinuous ImprovementMechanical EngineeringCathetersProduct DevelopmentLean ManufacturingPlastic Part DesignDesign ControlFinite Element AnalysisProgram ManagementInstrumentationTolerance AnalysisStaff DevelopmentProduct DesignSix SigmaDesign of ExperimentsManufacturingIso 13485Strategic PlanningProduct ManagementFmeaEducational LeadershipV&VPatentsMonte Carlo SimulationEngineeringTeam LeadershipSituational LeadershipProject PlanningBiomedical EngineeringConcept DesignPlasticsValidationDesign for ManufacturingTesting

ABOUT LUAN TRUONG

A Project Leader with extensive background in the medical device industry with multi-faceted experiences spanning from research, design control, product development, data analysis, project management, and effective leadership to drive product development from conceptualization to commercialization- Lean Sigma and Six Sigma Green Belt Certification- Working knowledge of high volume consumable product design, manufacturability, and assembly- Expertise in developing design requirements, generating design concepts, prototype builds, pre-clinical evaluations, and transferring to manufacturing- Ability to evaluate and analyze designs, and to determine design capabilities and margins through various techniques of Finite Element Analysis and statistical analysis- Experience in building electromechanical test fixture to simulate “in-use” condition in a controlled environment- Knowledgeable in various types of plastic joining techniques such as: UV adhesives, solvent bonding, ultrasonic welding, and induction heating- Working knowledge of regulatory, business development, and quality aspects of drug delivery device development- Experience in team building and motivation to drive department, project, and business critical results- Experience in driving complex and cross functional project comprising of FDA approved 510K and PMA devices- Proficient in solid modeling and analysis software, as well as, Microsoft Office PackageSpecialties: High Volume Consumables product, Infusion sets, Prefilled Cartridges, Diabetes Pump Therapy, Therapeutic Ablation Catheters, FEA, plastic injection molding, Six Sigma (DMAIC) Green belt, Design for Six Sigma (DFSS) Black Belt in training, electromechanical injection devices, wearable devices, combination product

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