# Lin Fu

> Medical Device Quality

Location: San Francisco Bay Area, United States
Profile: https://flows.cv/linfu

I am a passionate quality professional with in-depth technical background in medical device innovation and manufacturing.

Qualifications: 
M.Sc. in Data Science
M.Sc. and B.Sc. in Biotechnology and Bioengineering
Graduate Certificate Regulatory Affairs and Compliance (UCI)
ASQ Certified Quality Engineer (CQE)
ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
ASQ Certified Software Quality Engineer (CSQE)
Regulatory Affairs Certificate, US (RAC) 
Certified Six Sigma Green Belt (Dow Chemical)

## Work Experience
### Associate Director, Device Quality @ Eli Lilly and Company
Jan 2025 – Present | United States
Responsible for QA oversight of device contract manufacturing (CM)

### Director of Quality Assurance @ Telos Health
Jan 2023 – Jan 2025 | San Francisco Bay Area
We are currently working on innovative, advanced robotic-assisted technology at Telos, with the aim of revolutionizing the way ischemic stroke is treated.

My role is responsible for all quality assurance activities.

### Senior Manager, Quality Assurance @ Fresenius Medical Care
Jan 2023 – Jan 2023 | San Francisco Bay Area
Fresenius Medical Care is the world's leading provider of products and services for patients renal failure and chronic kidney disease (CKD).

My role is to ensure regulatory compliance and product design quality for FMC global Home Therapies Peritoneal Dialysis business.

### Manager, Design Quality and Engineering System Operations @ Fresenius Medical Care
Jan 2020 – Jan 2022 | San Francisco Bay Area
My role is to provide quality engineering support for the new product development and product sustaining.

### Quality Manager, Management Representative @ Innovative Surgical Designs, Inc.
Jan 2016 – Jan 2020 | Bloomington, Indiana Area
Innovative Surgical Designs is a spinal instrumentation and implant company dedicated to leading the marketplace in the creation of unique medical devices and surgical techniques to better patient outcomes and simplify procedures for surgeons and healthcare systems. The thought process behind our products is simple: Intuitive, Robust, Sterile.

My role is responsible for QA and QC activities.

### Test Engineer @ Innovative Surgical Designs, Inc.
Jan 2014 – Jan 2016
Led and completed R&D design control testing deliverables and worked closely with regulatory affairs, obtaining 510(k), CE mark and IDE (a PMA device, US studies going) approvals.

### Chemist/Project Lead @ Dow Chemical
Jan 2011 – Jan 2013 | Shanghai, China
Dow Water & Process Solutions is a leading purification and separation technology supplier, offering customers advanced ion exchange and membrane technologies that make water safer, cleaner and more available; food better; and pharmaceuticals more effective.

Hollow fiber ultrafiltration membrane production speed increase project.
Solved the critical technical challenge and implemented pilot-scale experiments and commercial-scale trials.

### Chemist @ Dow Chemical
Jan 2010 – Jan 2011 | Shanghai, China
First Year Rotational Research Assignments Program in Material Science, Core R&D, Shanghai Dow Center.

Conducted research support in the areas of waterborne epoxy hardener, formulation of thermoplastic cable jacketing and next generation antifouling ultrafiltration membrane.


## Education
### Master of Science in Data Science
Indiana University Bloomington

### Graduate Certificate in Regulatory Affairs and Compliance
UC Irvine

### Master of Science (M.Sc.) in Microbiology/Fermentation Engineering
Beijing Normal University

### Bachelor's degree in Bioengineering and Biotechnology
Tianjin University of Science & Technology


## Contact & Social
- LinkedIn: https://linkedin.com/in/lin-fu-465a4b2b

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Source: https://flows.cv/linfu
JSON Resume: https://flows.cv/linfu/resume.json
Last updated: 2026-04-13