1. Leading American validation team to build up verification/validation ability to verify/validate a new factory in South Carolina in the U.S.A, including tools, injection machines, pellet drying machine, forming machines, auto storage system, and auto assembly machines 2. Continuous improving verification/validation methods to match actual conditions 3. Performing RCA when the performance of the machine or the process does not meet the validation requirements and providing robust solutions to keep the program going forward 4. Mentoring other engineers

1. Leading a project of optimizing semi-manual assembly lines performance by relayout, sharing production area, rearrangimg material flow and working process. 2. Leading a production capacity expansion project across multiple departments by updating the machines and rearranging the layout, resulting in cost savings of around one million USD (from $1.2 million to $0.18 million) 3. Aligning and improving the verification process across departments by realigning verification/validation methods and SOPs, reducing lead time from almost 2 months to 1 day and preventing the cost of around 2 million USD (from $1.9 million to 2.3 thousand) 4. Setting requirements for machines to be used in a plastic injection molding production area in a new factory in the USA, and collaborating with vendors for structure design and development. 5. Supporting UX research of a product in Design phase 6. Training team members on qualification, verification and validation techniques, improving overall team performance

Process development: 1. Introduced and defined new manual and automated assembly lines (URS and SRM) 2. Reviewed and edited Design for Manufacturing documents (DOM) based on the risk in production. 3. Estimated cost, PPM, and OEE using LEAN methodology 4. Conducted market research, studied industry standards, and ensured regulatory compliance 5. Developed a tracking process for product life cycle management by machine design, aligning Critical Production Parameters (CPP), qualification, validation, routine production, and maintenance process, reducing the time and cost of the qualification process 6. Held Corrective and Preventive Action (CAPA) meetings, optimized work processes, and wrote work instructions Validation: 1. Validated/Qualified 3+ assembly machines, 2+ metallic materials, 10+ molding processes, and 2+ assembly processes based on ISO13485, FDA Part 820, and ISO9001 Quality Management System 2. Conducted troubleshooting by using fracture analysis, statistics, and macro/microstructure analysis 3. Coached validation engineers on Measurement System Analysis (MSA), risk analysis, and statistics Special contributions: 1. Improved laser marking process by modifying working parameters and providing a color-checking process and qualification method, preventing the company from incurring a penalty of around 2.3 million US dollars 2. Redefined NG sample specification for a vision inspection system by MSA skill and provided a process to re-validate the camera system, keeping the assembly line in validated status and preventing the company from breaching the contract

1. Specialized in macrostructure analysis and laser application. 2. Developed an advanced 3D printing process for low-cost, high-strength continuous/long fiber reinforced thermoplastic composites by microstructure analysis. This process is suitable for the aerospace and vehicle industries.

1. Researched and recommended new vehicle assembly processes in metallic materials to the design team, improving the efficiency and quality of the assembly process, ultimately contributing to a better end-product. 2. Ensured compliance with regulations and industry standards for design weights of new cars. 3. Analyzed vehicle market and reported statistical data to the project office, providing insights for modifying business strategies and improving market competitiveness. 4. Developed a standard process to quantify audio sensing and enhance the quality of new cars, which was eventually added as a primary stage in the development process.

Title : Combat engineer

1. Conducted research on metallic material manufacturing processes, including welding and forming, through microstructure analysis. 2. Developed a new welding process that fused tungsten carbide to stainless steel, resulting in a more than 10% increase in the durability of products for DE POAN PNEUMATIC CORP