YU-JU LU
In Vitro Diagnostic R&D
Taoyuan City
Summary
Experienced biomedical engineer specializing in IVD product development, process optimization, and regulatory compliance. Adept at enhancing manufacturing operations and resolving complex technical challenges. Demonstrated expertise in driving innovation and ensuring quality control throughout the product lifecycle. Committed to delivering cutting-edge solutions that improve patient outcomes and meet industry standards.
Overview
8
8
years of professional experience
2
2
years of post-secondary education
Work History
Engineer
PROTECTLIFE INTERNATIONAL BIOMEDICAL INC.
09.2021 - Current
- Transit/Optimize animal-use IVD products to human-use IVD products (3 products)
- Design input verification and validation
- Optimize underdeveloped product to improve original specification (3 products)
- Production line establishment and optimize production parameters and SOP establishment
- Maintain/improve/handle customer complaint of listed product
- Report/technical files writing for CE/TFDA certification
Assistant Supervisor
APEXBIO CORP.
02.2019 - 02.2021
- Manage POCT-IVD project progress, gantt chart review and renew to achieve the design input
- Design input verification and validation
- Optimize underdeveloped product to improve original specification
- Production line establishment and optimize production parameters and SOP establishment
- Maintain/improve/handle customer complaint of listed product
- Report/technical files writing for CE certification
Associate Researcher
APEXBIO CORP.
03.2017 - 02.2021
- Establish the measurement method (immunoturbidity) to detect target antigen in urine and integrate this method into existing system
- Optimize underdeveloped product and change design to have better expansion in future
- Maintain listed product and optimize manufacturing process
- Specific experience – attending the 2018 Medica exhibition at Dusseldorf for prototype/new product debut and trouble shooting for customers
Education
Master of Science - Cellular And Molecular Biology
National Tsing Hua University
Hsinchu 09.2009 - 07.2011
Skills
Project planning
Project management
Product development
Timeline
Engineer
PROTECTLIFE INTERNATIONAL BIOMEDICAL INC.
09.2021 - Current
Assistant Supervisor
APEXBIO CORP.
02.2019 - 02.2021
Associate Researcher
APEXBIO CORP.
03.2017 - 02.2021
Master of Science - Cellular And Molecular Biology
National Tsing Hua University
09.2009 - 07.2011
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