J Liu
General Manager @ Medennium Inc. | Medical Device Design Expert | Ex Abbott | Ex Alcon
- Role
- General Manager and Qmr at Medennium Inc
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About J Liu
Experienced data-driven medical device product design innovator with 16+ years in design and manufacturing of micro/meso-scale mechanical device & systems using advanced materials and processes.
Experience
General Manager and Qmr
Aug 2023 — Present · Irvine, CA, US
Lead company-wide operations, driving strategy, financial performance, and cross-functional execution for growth and compliance- Champion R&D innovation and design transfer, ensuring new product development meets regulatory and quality standards- Oversee production operations, optimizing efficiency, scalability, and compliance through strong resource and quality controls- Serve as Management Representative under EU MDD/MDR, ISO 13485, and FDA QSR, sustaining a robust and compliant Quality Management System- Ensure global regulatory compliance, including MDR CER submissions and Notified Body audits, securing international market access- Build and manage supplier and distributor partnerships, aligning quality, cost, logistics, and compliance objectives- Drive process excellence through continuous improvement and supplier quality enhancements- Represent the company in audits, inspections, and customer engagements, reinforcing trust and compliance leadership.
Education
China University of Mining and Technology
B.S., Mechanical Engineering
2002 — 2006
University of Central Florida
M.S., Mechanical Engineering
2009 — 2011
University of Central Florida
Ph.D., Mechanical Engineering
2009 — 2012
Beihang University
Mechanical Engineering
Skills
- Minitab
- Abaqus
- Labview
- Hypermesh
- 3d Prototyping
- Python
- Sem
- Thermodynamics
- Mechatronics
- Matlab
- Medical Devices
- Solidworks
- System Dynamics
- Medical Device R&D
- Mechanical Engineering
- Afm
- Engineering
- Profilometry
- Ptc Creo
- Comsol
- Quantative Analysis
- Ls-Dyna
- 3d Printing
- Autocad
- Fda
- Confocal Microscopy
- Profilometer
- Pxi
- Design of Experiments
- Manufacturing
- Heat Transfer
- Signal Processing
- Simulink
- Fluid Mechanics
- Design for Manufacturing
- Cfd
- Process Control
- Design Control
- Statistical Data Analysis
- Mems
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