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Designed and built an automatic Fatigue Testing system that includes RF generator & electromagnet system with saline water circulation and Labview monitoring. The documentation included 85 component and assembly drawings.

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Simplified structure of heart valve by improving the frame assembly design, reducing the number of parts by 30% and enhancing product durability.

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Improved documentation of Accelerated Life Tester; integrated and streamlined drawings from 5 sources to reduce file handling time from 13 minutes to 1 minute.

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Generated IQ/OQ for high temperature furnace to improve the traceability of the nitinol product; increased process productivity by factor of 12.

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Implemented Lean Manufacturing to increase yield of FC from 91% to 100%.

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Investigated "action wire broken" problem which had caused complete product failure;  improved assembly handling process to solve this 5-year-old issue.

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Researched "electrical short" problem which had caused complete catheter failure, improved assembly design and process to solve this 7-year-old issue.

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Improved training program by creating clear and concise flow diagram with main manufacturing process images and codes.

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Repaired and developed test plan for new Induction Welder to solve 2-year-old issue.

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Conducted testing of a thousand samples, and wrote report for plastic fusing process.

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Generated process instruction (PI) for plastic tube fusing, which improved the stability of the process and increased productivity by 8%.

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Introduced pneumatic welding system and performed process validation.

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Introduced automatic equipment which increased productivity by a factor of 10.

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Adopted the CNC lathe to make electrode more accurate and consistent, reducing the cost of labor and materials.

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Solved 5-year-old “short band” issue on connector assembly and improved process quality from 95% to 99%.

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Analyzed root causes of “broken plunger” problem and conducted quality meeting with QC and vendors; reduced rejection rate by 12% and increased productivity by 8%.

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Utilized FMEA and 6-sigma tool to reduce “non-continuity” scrap by 7%.

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Investigated contaminated package from customer; traced source of contamination to international supplier to eliminate the issue.

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Performed CAPA with Regulatory Compliance Department by dissecting “S” curve reject from customer and provided practical improvement recommendation.

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Worked on non-conforming screw problem with local and international suppliers to solve 2-year-old issue.

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Improved design of high precision fixtures to reduce maintenance time from 8 hours to 30 minutes.

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Performed IQ/OQ for new annealing oven and temperature controller/recorder.

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Improved maintenance process for PLC-pneumatic hot-glue packaging system to eliminate safety issues.

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Improved the preventive maintenance documentation system by establishing PMP’s, updating equipment data base, and organizing engineering shop and parts inventory.

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Provided training for programming and maintenance of PLC hydraulically- controlled heat molding system.

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Designed and built product cooling system, which included cooling tower, chiller, HVAC wiring, electrical control, and piping system; increased productivity by 15%.

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Troubleshoot and adjusted the filling machine to solved 6-moths issue.

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Improved cam plate design for new plastic bottle capping machine, saving 1200 labor hours per month.

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Conducted the failure analysis meeting and completed the accident investigation for the deformation of a 2000-gallon steam cooker; result was a large settlement from the vendor’s insurance for the defective equipment.

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Generated plant layouts for storage management, pest control, and fireproofing system management.

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Conducted the overhaul of two 5-lb Can Filling & Sealing Machines that were made in Spain 25 years ago.

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Established the documentation system for the engineering department to meet ISO 9001 and GMP standards.