Ya-Jen Yu

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Ya-Jen Yu, PhD

SUMMARY OF QUALIFICATIONS

PhD degree in Biomedical Engineering with 5+ years industry experience in material-based medical device application/design.

Active technical leadership with experience in new product development and lifecycle management, continuous improvement, cost reduction & estimation, regulatory survey, timeline tracking & planning, preparation of scientific report and documentation to speed the product launch.

Strong analytical skills and material characterization in selection, specification, failure investigation, processing development to support projects and long term business need.

Author study protocol/study plan, analyze data using Minitab, present study summary conclusion, and provide recommendations to project and leadership team.

Survey IP landscape and 23 co-authored Patents from USA, Taiwan (ROC), China (PROC).

Highly motivated team player with excellent communication, problem solving skills during product development and manufacturing, strong ability to multitask, and willing to learn.

US Citizen with legal right to work in the USA.

Material: Medical & Cosmetic foam, PU-based shape memory foam, Electroactive SMP composites, Hydrogel, PLGA, Silicone, PEEK, PTFE, Hydroxyapatite, Nitinol-based shape memory alloy Device: Shape memory foam for aneurysm repair, Electroactive SMP device for thrombus removal, Biphasic scaffold for cartilage regeneration, Thermosensitive bioglue for bone tissue repair, Fusion cage for spinal disc degeneration repair, Wound care foam Skills: Statistics (Minitab), Design of experiment (DOE), Computer aided design (CAD-SolidWorks), Failure mode effect analysis (FMEA), Root cause investigation, Design control, Design history file, Six Sigma (DMAIC), ISO 13485, ISO 10993, ISO 9001, Verification/Validation, IQ OQ PQ

Analysis: DSC, DMA, TGA, SEM, TEM, FTIR, X-ray Diffraction, Mechanical testing, Contact angle measurement, Laser process, Finite Element (COSMOS), and Electrical property measurement PROFESSIONAL EXPERIENCE

R&D Product Development Engineer

Filtration Group Corporation (Porex) July 2018-Dec 2019

Led and developed urethane-based foam in medical and cosmetic application from engineering feasibility/concept/prototype to production development to full scale manufacturing line. o Worked closely with the commercial teams (sales and marketing) to identify, establish and manages new technology/product development, product lifecycle management projects o Transferred the customer and end-user’s opinions efficiently to meet the product development and design requirement following the industry regulatory. o Led and assessed the new product development projects within the pipeline (project lifecycle management, IP, risk management, technology gap analysis, statistical analysis, statistical process control (SPC), supplier qualification and capability). o Extensive collaboration with sales team and customers across the Americas, Asia, and Europe to expedite development and speed to market; Internal collaboration and communication with cross-functional team to successfully scale-up/transfer the new technologies/products to commercialization; External collaboration with outside partners/supplies. Postdoc

Yen Tjing Ling Industrial Research Institute 2014-2018

Led and developed organic/inorganic composites for bone regeneration. adfo7d@r.postjobfree.com

858-***-****

6190 Fox Glen Drive #187, Saginaw, MI 48638

Ya-Jen Yu

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o Sintered the polymer scaffold in the different ratio of poly(lactic-co-glycolic acid)/bioceramic. o Casted the porosity geometry of composites in the different shape. Graduate Research Assistant (PhD program) 2009-2014 Biomedical Device Lab at Texas A&M University

Led and analyzed polyurethane SMP foams with moisture effect for treating brain aneurysms. o Crimped SMP foam is inserted into a catheter, then delivered into the cerebral aneurysm by catheter and expanded by heat to fill the aneurysm to replace the original platinum coil design. o Identified the shape memory recovery under different temperature and moisture condition.

Designed and analyzed the effect of electroactive SMPs with loading carbon fibers for neurovascular device application in minimally invasive surgery.

o The device with straight shape is delivered through a catheter to pierce the blood clot, and then the device is transformed to its primary corkscrew shape to remove the clot as it is retracted. o Characterized the microstructure, dispersion, thermomechanical behavior (fiber reinforced), electrical resistivity, electrical resistive heating of electroactive SMPs composite.

Analyzed the electroactive SMPs with silicone membrane coating under water absorption effect. o Coated with silicone membrane, the SMPs device is waterproof from 5 mins to 6 hrs.

The research performance belongs to “Shape Memory Medical, Inc.” R&D Engineer 2003-2008

Biomedical Technology and Device Research Laboratories at Industrial Technology Research Institute (ITRI), Taiwan

Bioglue for bone tissue repair: Project Leader for a 5-member team (2 PhDs and 1 physician) o Identified the strategy and application to develop thermosensitive and biodegradable di-block copolymer with drug delivery to mend comminuted fractures. o Survey IP landscape for different molecular architecture copolymer. o Implanted into animal to do primary test to observe the bone regeneration.

Novel spinal cage profile

o Designed a PEEK cervical cage with pre-incorporated bone graft for implant into intervertebral disc space to eliminate the need for cumbersome insertion of autogenous bone graft.

(Technology transferred into “Wiltrom Co.,Ltd.”)

o Surveyed IP landscape and evaluated cage prototype design with pre-incorporated bone graft.

Biphasic scaffold for articular cartilage regeneration o Assisted in developing manufacture process of 3-D porous scaffold (mixing PLGA and Hydroxyapatite) for seeding cartilage cells. (Technology transferred into “Exactech, Inc”) o Improved a tissue pulverizer design to cut healthy cartilage tissue into small pieces well. o Developed documentation of new Good Manufacturing Practice (GMP). EDUCATION

o Ph.D.: Biomedical Engineering, Texas A&M University, College Station, TX 2014 o M.S.: Material Science & Engineering, National Taiwan University, Taipei, Taiwan 2003 o B.S.: Material Science & Engineering, Feng Chia University, Taichung, Taiwan 2001 PATENTS

1. Y.J. Yu, C.F. Chen, T.Y. Lin, S.J. Yeh,, S.Y. Wang and P.L. Lai, “Biodegradable copolymer and thermosensitive material,” US 7884142

2. M.Z. Shiu, Y.S. Weng, C.F. Chen, R.J. Gau, Y.J. Yu, and S.J. Yeh, “Hydrogel composition for cell culture apparatus,” US 7749761

3. C.C. Jiang, S.C. Chueh, T.H. Chiu, C.J. Liao, Y.H. Lin, Y.J. Yu and I.F. Chiu, “Device and method for affixing soft tissue,” US 8043347

4. Y.J. Yu, C.F. Chen, T.Y. Lin, S.J. Yeh,, S.Y. Wang and P.L. Lai, “Biodegradable copolymer and thermosensitive material,” US 8309623

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5. M.Z. Shiu, Y.S. Weng, C.F. Chen, R.J. Gau, Y.J. Yu and S.J. Yeh, “Cell culture apparatus and a fabricating method of the same,” US 8129188

6. C.C. Jiang, S.C. Chueh, T.H. Chiu, C.J. Liao, Y.H. Lin, Y.J. Yu and I.F. Chiu, “Device for fixing soft tissue,” US 8435271

7. Y.H. Tsuang, C.J. Chiang, S.C. Chueh, C.J. Liao, C.N. Chen, Y.J. Yu, “Spinal cage and implant method thereof” US 201********

8. Y.S. Weng, Y.H. Lin, Y.J. Yu, S.C. Chueh, I.C. Wu, C.I. Huang, “Interspinous Stabilization Device,” US 201********

9. Y.S. Weng, C.W. Yu, Y.H. Lin, I.H. Wu, Y.J. Yu, W.J. Chen, S.C. Chueh, C.I. Chuang, J.L. Wang, and S.Y. Wang, “ Spine dynamic stabilization device,” US 200********-**. W.H. Tuan, Y.J. Yu, H.C. Hsu, and Y.J. Huang, “Ceramic reinforcement material,” US 200********-**. W.H. Tuan, Y.J. Yu and C.Y. Chen, “Hydroxylapatite Powder, Porous body and Method for Preparing Thereof,” US 200********

12. Y.J. Yu, C.F. Chen, T.Y. Lin, S.J. Yeh,, S.Y. Wang and P.L. Lai, “Thermosensitive material,” ROC I388591

13. C.C. Jiang, S.C. Chueh, T.H. Chiu, C.J. Liao, Y.H. Lin, Y.J. Yu and I.F. Chiu, “Device for fixing soft tissue,” ROC I353237

14. Y.S. Weng, C.W. Yu, Y.H. Lin, I.C. Wu, Y.J. Yu, W.J. Chen, S.C. Chueh, C.I. Chuang, J.L. Wang, and S.Y. Wang, “ Spinal dynamic stabilization device,” ROC I401059 15. M.Z. Shiu, Y.S. Weng, C.F. Chen, R.J. Gau, Y.J. Yu and S.J. Yeh, “A method of forming biocompatible polymer scaffold and cell pattern scaffold structure,” ROC I319004 16. W.H. Tuan, Y.J. Yu, H.C. Hsu, and Y.J. Huang, “Ceramic reinforcement material,” ROC I310348 17. W.H. Tuan, Y.J. Yu and C.Y. Chen, “Hydroxylapatite Powder, Porous body and Method for Preparing Thereof,” ROC I230058

18. Y.H. Tsuang, C.J. Chiang, S.C. Chueh, C.J. Liao, C.N. Chen, Y.J. Yu, “Spinal cage and implant method thereof” ROC I397395

19. Y.J. Yu, C.F. Chen, T.Y. Lin, S.J. Yeh,, S.Y. Wang and P.L. Lai, “Biodegradable copolymer and thermosensitive material,” ROC I388591

20. Y.S. Weng, C.W. Yu, Y.H. Lin, I.C. Wu, Y.J. Yu, W.J. Chen, S.C. Chueh, C.I. Chuang, J.L. Wang, and S.Y. Wang, “ Spinal dynamic stabilization device,” PROC 101******-**. W.H. Tuan, Y.J. Yu and C.Y. Chen, “Hydroxylapatite Powder, Porous body and Method for Preparing Thereof,” PROC 200410070253.2

22. Y.S. Weng, C.W. Yu, Y.H. Lin, I.C. Wu, Y.J. Yu, W.J. Chen, S.C. Chueh, C.I. Chuang, J.L. Wang, and S.Y. Wang, “ Spinal dynamic stabilization device,” PCT 201*****-**. Y.S. Weng, C.W. Yu, Y.H. Lin, I.C. Wu, Y.J. Yu, W.J. Chen, S.C. Chueh, C.I. Chuang, J.L. Wang, and S.Y. Wang, “ Spinal dynamic stabilization device,” EPC 20140106 PUBLICATIONS

1. Y.J. Yu, S. Infanger, M.A. Grunlan, and D.J. Maitland, “Silicone Membranes to Inhibit Water Uptake into Thermoset Polyurethane Shape-Memory Polymer Conductive Composites,” J. Appl. Polym. Sci., 131, 41266, 2014.

2. J.N. Rodriguez, Y.J. Yu, M.W. Miller, T.S. Wilson, F. J. Clubb, B. Gentry, and D.J. Maitland,

“Opacification of Shape Memory Polymer Foam Designed for Treatment of Intracranial Aneurysms,” Ann. Biomed. Eng., 40(4):883-97, 2012.

3. Y.J. Yu, K. Hearon, T.S. Wilson, and D.J. Maitland, “The Effect of Moisture Absorption on the Physical Properties of Polyurethane Shape Memory Polymer Foams,” Smart Mater. Struct., 20, 085010, 2011.

4. W.H. Tuan, Y.J. Yu, and Y.L. Chin, “From biomimetic concept to engineering reality – A case study on the design of ceramic reinforcement”, Adv. Eng. Mater., 13(4):351-55, 2011. 5. C.F. Chen, H.H. Shen, T.Y. Lin, Y.J. Yu, W.C. Chen, and I.M. Chu, “Studies on the Preparation and Characterization of mPEG-Polyesters Biodegradable Bioglue for Bone Defect Repair” J. Med. Biol. Eng., 31(1):14-17, 2011.

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