Luan Truong
Sr Manager Quality Complaints @Amgen
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WORK HISTORY
Sr Manager Quality Complaints @Amgen
EDUCATION
California State University, Northridge
B.S, Mechanical Engineering
California State University, Northridge
M.S., Mechanical Engineering
SKILLS
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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