June 2017 - December 2022
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🎯 HIGHLIGHTS
- 5+ years of Medical Device R&D Experience
- Early Stage Product Design and Prototyping
- Medical Device Design Control and Risk Management
- Problem-Solving: Lean Six Sigma Black Belt Certified
- Filed 5 patents in the United States Patent and Trademark Office (1 Formal Patent, and 4 Provisional Patents)
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🫀 Edwards LifeSciences
Senior Reserach and Development Engineer
September 2019 – June 2022
- Designed a Suture Routing Method to simplify implant release procedure from 2-step process to 1-step process in to streamline clinical procedure and minimize user errors. Filed 4 Provisional Patents.
- Developed design Specifications using DOE analysis to finalize new product design
- Led Design Verification (65 tests) to extend shelf life to avoid financial burden of expiring units (~$7M)
- Led a pivotal Biocompatibility and Toxicological Assessment project as the initiator to qualify design/process changes of 58 EA implantable components. Through continuous research and communications with crossfunctional team and scientists, successfully reduced testing duration from 9 months to 3 months to meet the business goal.
- Investigated complaint issues using six sigma black belt techniques to identify root causes and proposed immediate solutions as short-term corrections and long-term solutions as preventitive and/or corrective actions to reduce complaint occurrence.
💉 Applied Medical
Product Development Engineer II
June 2017 – August 2019
- Led a pilot project to update Design Control and Risk Management documents, including Design Input, Design Output, d/p/a Failure Mode Effect Analysis (FMEA), to enhance the traceability of design control documents
- Designed a production fixture using SolidWorks to improve ergonomics for operators, process accuracy and efficiency, performed process validation and production-released fixture to increase yield.
- Created a process/script that continuously extracts sensor data from production logs and sinks it into a MySQL database. Developed ETL pipelines for a real-time system efficiency evaluation program using Python libraries such as Pandas and Matplotlib. Designed and developed a real-time monitoring system using the Django framework, which allowed the team to continuously monitor data and provide real-time updates.
- Promoted from Engineer I to Engineer II after 6 months of work and supervised Engineer I as my direct report.
🧬 Capstone Project @ Georgia Tech 🐝➰
Development a Cervical Device for Prevention of Preterm Birth
January 2017 – May 2017
- Designed and developed a cervical device and pelvic testing model based on the pathological condition of patients.