Experience

Bionime 華廣生技

• Taiwan
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Assistant Quality Assurance Manager

  • Dec 2020 - Present

• Senior Quality Assurance Engineer

  • Feb 2020 - Nov 2020



Zimmer Biomet

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Development Engineer

  • Apr 2017 - Oct 2019

  Warsaw, Indiana ● Implemented risk-based design control process from user need/design input/interaction identification to quality assured verification/validation. ● Made verification plan of orthopedic device systems to ensure compliance with current FDA standards ● Determined appropriate closure activities for unresolved verification gaps ● Collaborated with cross-functional teams consisting of development, quality, regulatory, and research engineers to update the need for verification and… Show more ● Implemented risk-based design control process from user need/design input/interaction identification to quality assured verification/validation. ● Made verification plan of orthopedic device systems to ensure compliance with current FDA standards ● Determined appropriate closure activities for unresolved verification gaps ● Collaborated with cross-functional teams consisting of development, quality, regulatory, and research engineers to update the need for verification and validation Show less



Geri-Safe

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Medical Device Designer

  • Oct 2015 - Aug 2016

  Cornell University, Weil Hall ● Promoted the product development process in designing an upgraded 3-wheel walker (Class I medical device) and improving users’ mobility with a persistent passion for the effective self-learning - Conducted literature review and field study to analysis and conclude the critical points which provided the most effective support for the end users - Initiated teammates’ enthusiasm for design by creating the first 75% design drafts - Visualized the latest… Show more ● Promoted the product development process in designing an upgraded 3-wheel walker (Class I medical device) and improving users’ mobility with a persistent passion for the effective self-learning - Conducted literature review and field study to analysis and conclude the critical points which provided the most effective support for the end users - Initiated teammates’ enthusiasm for design by creating the first 75% design drafts - Visualized the latest design to a 3D prototype miniature and a workable prototype with the self-developed skills of 3D modeling software (SolidWorks), 3D printer, engineering graphics (GD&T) and hands-on ability ● Planned experiments to validate the effectiveness of the improvement through data analysis using Matlab with colleagues from U.S., China, India. - Performed force distribution analysis and motion analysis on our prototypes and a commercial product to compare their performance ● Managed non-disclosure documents including development records, design history files, and references Show less



Cornell University

• United States
• Higher Education
• 700 & Above Employee

• Student Computer Assistant

  • Mar 2016 - Jul 2016

  Student Disability Services, Access Media Resource Center • Proofread digital textbooks for the convenience of students with disabilities



National Cheng Kung University

• Taiwan
• Higher Education
• 700 & Above Employee

• Research Assistant

  • Jan 2013 - Feb 2015

  Biofluids and Micro-Opto-Electro-Mechanical Systems Laboratory, Department BME

• Administrative Assistant

  • Jul 2012 - Apr 2013

  The Affiliated Senior Industrial Vocational Continuing Education High School, D • Performed administrative and office support activities including fielding telephone calls, receiving and directing visitors, word processing, creating spreadsheets, and filing • Assisted in two major projects: 1) the recruitment of teaching faculty and 2) the annual celebration