Engineer Mechanical

SHI-SHEN YAU

** ******* *****, ******** *******, NJ 07922-1742

908-***-****; *******@*****.***

QUALIFICATION SUMMARY:

An engineer and a scientist with more than 15 years of experience in: (1) characterizing

physical/chemical/mechanical/wear behavior of polymers, and serving as SME on Material

Review Board, (2) developing and enhancing performance of polymeric based materials/products

by radiation and traditional processing methods, (3) establishing in-house processing and

evaluation capabilities, (4) improving medical device packaging/sterilization processes,

(5) resolving in-house and supplier manufacturing issues, (6) negotiating/coordinating Surgeon,

Vendor, Regulatory, Clinical Research, Manufacturing, Marketing, Supply Chain/Quality, QA,

R&D and Legal requirements, and (7) conducting/reviewing investigation on medical device

product complaints for failure mode/root cause and corrective/preventive actions (CAPA).

Published over 20 patents/patent applications and 40 peer reviewed research articles in orthopedic,

biomaterials and materials fields.

Familiar with FDA, ASTM and ISO specifications/standards; Active member of ASTM D30

Composite Materials, E35.15 Antimicrobial Agents, E61 Radiation Processing, F02 Flexible

Barrier Packaging, F04 Medical and Surgical Materials and Devices; Recognized for making

standards more user friendly.

Bilingual and bi-literate in English and Chinese (Mandarin) languages.

EXPERIENCE:

Stryker Orthopaedics (Howmedica Osteonics Corp) Mahwah, New Jersey

Principal Research Engineer 12/98 to 11/13

Major Responsibilities:

• Develop and enhance performance of polymeric based joint replacement devices

• Initiate process specifications and SOPs for polymeric based joint replacement devices/trials

• Conduct audit/evaluation as SME for material suppliers and device/company acquisitions

• Supervise temporary engineers in executing projects and incoming material inspections

• Mentoring and developing junior engineers

• Serve as SME on Material Review Board (MRB) and during in-house/FDA/BSI audits

• Negotiate/Coordinate requirements within surgeon, vendor, regulatory, marketing, supply

chain/quality, QA and R&D

• Conduct/Review investigation on product complaints

- Investigate/report failure modes, severity of injury, implantation issues, etc.

- Recommend corrective/preventive actions

- Discuss observations with surgeon consultants and Legal Department

• Attend ASTM committee meetings

Accomplishments:

• Co-invented the bestselling, X3®, highly crosslinked ultra-high molecular weight polyethylene

(UHMWPE) in joint replacement device industry

- Convinced patent examiner during face-to-face meetings that X3® process is unique

- Conducted physical/chemical/mechanical property validation testing and wear tests on MTS

hip/knee simulators

- X3® devices sales contributed to significant portion of Stryker Corporation revenue

• Setup in-house extraction and analysis capabilities to evaluate residues of manufacturing

agents on surfaces of devices

• Developed highly crosslinked UHMWPE devices interlocked with titanium foam base plate

• Developed highly crosslinked UHMWPE with anthocyanin antioxidant

• Developed PAEK-on-polymer bearings for joint replacement

• Negotiated and significantly lowered purchasing cost of premium medical grade engineering

thermoplastic materials

• Developed surface crosslinked UHMWPE

• Elevated 2 junior engineers

- 1 junior engineer was selected/honored as employee of the year in 2011 and 2012

- 2 junior engineers received promotions in 2011

• Elevated all temporary engineers to internal or external permanent positions

• Converted major surgeons/hospital accounts in Japan

• Determined root causes and corrected manufacturing issues at vendors

• Explored the potential of using braided UHMWPE yarns to replace CoCr cables

• Confirmed shelf aging stability of biocompatible implant grade polyurethane

• Determined/Located root causes and recommended corrective/preventive actions for key

products after receiving products complaints

• Served as co-chair on ISO/ASTM 51707, Guide for estimating uncertainties in dosimetry for

radiation processing, task group; Changed/Clarified standards related to UHMWPE, PAEK

family, bone cement, device cleanliness, biocompatibility, corrosion as well as MRI, and

participated in inter-laboratory round robin

Howmedica Inc., Pfizer Medical Technology Group Rutherford, New Jersey

Principal Research Engineer 12/97 to 12/98

Senior Research Engineer 4/92 to 11/97

Major Responsibilities:

• Prepare documents for FDA 510(k) device clearances

• Develop thermoplastic-based composite orthopedic products

• Establish in-house polymeric materials evaluation capabilities and procedures

• Define alternative packaging and sterilization processes for orthopedic devices

• Define UHMWPE manufacturing processes and enhance their performance for orthopedic

applications

• Perform thermal, stress/failure analyses and write material evaluation reports for returned or

explanted joint replacement devices

Accomplishments:

• Prepared process and material property specifications for 6 premarket notifications, 510(k)s

• Developed carbon fiber reinforced PEEK composite hip stems with ingrowth textures

• Established thermal, FTIR, optical/scanning electron microscopy evaluation protocols

• Defined packaging and gas plasma sterilization processes for orthopedic devices

• Established analysis protocol for retrieved or returned joint replacement devices

• Established oxygen permeability for evaluating UHMWPE consolidation

• Improved wear resistance and shelf life of gamma-ray sterilized medical plastics

Phillips Petroleum Company Bartlesville, Oklahoma

Associate Research Engineer 2/87

to 4/92

Major Responsibilities:

• Develop high temperature continuous fiber reinforced thermoplastic sheets and composite

prepregs for high temperature (350 F), aerospace applications

• Specify stampable sheet (with glass swirl mat) products

• Define autoclave and compression molding processes

• Install aerospace mechanical testing capabilities

Accomplishments:

• Developed unidirectional/fabric prepregs and stampable sheets

• Identified stamping, autoclave and molding process windows

• Eliminated thermal stresses induced microcracks

• Designed and performed in-situ mechanical tests in a SEM

• Established in-house aerospace OHT, OHC, CAI evaluation capabilities

• Enhanced durability of semi-crystalline PPS composites in terms of compression after impact

strength and strength retention in hot/wet environment

• Established a material-process-property relational database

Center for Composite Materials, University of Delaware Newark, Delaware

Associate Scientist 10/83 to 2/87

Major Responsibilities:

• Lead a research team (2 visiting scholars, 8 graduate and 3 undergraduate students)

• Secure and coordinate research funding

• Develop polymer composites reinforced with 3-D braided fiber

• Perform stress and failure analysis

• Publish research results

North Carolina State University Raleigh, North Carolina

Research Assistant/Associate, Department of Materials Engineering 1/79 to 9/83

• Performed research on corrosion fatigue of aluminum matrix composites

Florida Atlantic University Boca Raton, Florida

Research Assistant, Department of Ocean Engineering 9/76 to 12/78

• Studied effect of chelating agents on performance and corrosion resistance of steel reinforced

concrete

EDUCATION:

Ph.D. Materials Engineering with Minor in Textile Fibers

North Carolina State University, Raleigh, North Carolina 1983

M.S. Ocean Engineering with Specialty in Ocean Structures and Corrosion

Florida Atlantic University, Boca Raton, Florida 1978

B.S. Oceanography

National Taiwan Ocean University, Keelung, Taiwan, Republic of China 1973

TRAINING:

Six Sigma Green Belt

Negotiation

Potential failure mode and effects analysis (FMEA)

GMP/CAPA/QSR

Supervision

Problem solving and decision making

Project management

ANSYS finite element analysis

X-ray microanalysis and computer aided imaging

Polymer processing

Design of experiments/Minitab

Separation of fluid mixtures

Distillation

Injection molding

Strain gauging

Laboratory Instrument: DSC, FTIR, TGA, DMA, Density column, Titration, TurboVap, SEM,

Instron mechanical/impact testers, MTS hip/knee wear simulators, strain gage, compression

molding

PROFESSIONAL SOCIETIES:

Alpha Sigma Mu (HONORARY)

American Society for Testing and Materials

Society for Biomaterials

Materials Research Society

SELECTED PATENTS/PATENT APPLICATIONS:

1. US 7517919 Sequentially cross-linked polyethylene

2. US 8133436 Polyethylene cross-link with an anthocyanin

3. US 2010/0312348 Orthopedic PAEK-on-polymer bearings

4. US 2011/0276143 Surface crosslinked polyethylene

PUBLICATIONS:

1. Influence of selected chelating admixtures upon concrete cracking due to embedded metal

corrosion, Corrosion of Reinforcing Steel in Concrete, ASTM STP 713, American Society for

Testing and Materials, Philadelphia, 1980, with W. H. Hartt.

2. Fatigue crack propagation in polycarbonate foam, Mater. Sci. & Eng., Vol. 78, 1986, with G.

Mayer.

3. Fatigue of metal-matrix composites, Mater. Sci. & Eng., Vol. 82, 1986, with G. Mayer.

4. Stress-corrosion cracking and its propagation in aligned short fiber composites, J. Mater. Sci.,

Vol. 21, 1986, with P. L. Hsu and T. W. Chou.

5. Flexural and axial compressive failure of three-dimensionally braided composite I-beams,

Composites, Vol. 17, No. 3, 1987, with F. K. Ko and T. W. Chou.

6. Notched strength of woven fabric composites with molded-in holes,” Composites, Vol. 18, No.

3, 1988, with W. L. Chang and T. W. Chou.

7. Strength of woven fabric composites with drilled and molded holes, Eighth Symposium on

Composite Materials: Testing and Design, ASTM STP 972, American Society for Testing and

Materials, Philadelphia, 1988, with T. W. Chou.

8. Effects of low temperature on short fiber reinforced thermoplastics, The Second Symposium

on Test Methods and Design Allowables for Fiber Composites, ASTM STP 1003, American

Society for Testing and Materials, Philadelphia, 1988, with T. W. Chou.

9. The effect of processing on the mechanical properties of PAS-2 composite laminates, SPE

Conference, Los Angles, November 15 - 17, 1988.

10. Durability characteristics of PPS advanced thermoplastic composites,” Proceedings of the 23rd

International SAMPE Technical Conference: Advanced Materials/Affordable Process, Kiamesha

Lake, New York, October 21-24, 1991.

11. The location of the oxidation maximum in relationship to the post-radiation history of

UHMWPE implants, 5th World Biomaterials Congress, Toronto, Canada, May 29-June 2, 1996,

with D. C. Sun, C. Stark, and J. H. Dumbleton.

12. Orientation softening as a mechanism for polyethylene wear in acetabular cups, Symposium on

Characterization and Properties of Ultra-High Molecular Weight Polyethylene, American Society

for Testing and Materials, New Orleans, LA, November 19, 1996, with A. Wang, B. Edwards, M.

Sokol, D. C. Sun, C. Stark and J. H. Dumbleton.

13. Correlations between oxidation, crosslinking, and wear performance of UHMWPE, 43rd

Annual Meeting of the Orthopaedic Research Society, San Francisco, CA, February 9-13, 1997,

with D. C. Sun, G. Schmidig, M. Jeanty, A. Wang, C. Stark and J. H. Dumbleton.

14. Orientation softening in the deformation and wear of ultra-high molecular weight polyethylene,

11th International Conference on Wear of Materials, San Diego, CA, April 21-24, 1997, with A.

Wang, D. C. Sun, B. Edwards, A. Essner, V. K. Polineni, C. Stark and J. Dumbleton.

15. Assessment of gel content and crosslinking density in UHMWPE, 23rd Annual Meeting of the

Society for Biomaterials, New Orleans, LA, April 30-May 4, 1997, with D. C. Sun, G. Schmidig,

M. Huffman, C. Stark and J. H. Dumbleton.

16. Quantitative evaluation of particle consolidation in UHMWPE by oxygen permeability, 24th

Annual Meeting of the Society for Biomaterials, San Diego, April 22-26, 1998, with D. C. Sun, B.

Edwards, C. Stark and J. H. Dumbleton.

17. Prevention of oxidation in the manufacturing of UHMWPE implants, 3rd Combined Meeting of

Orthopaedic Research Societies of USA, Canada, Europe and Japan, 28–30 September 1998,

Hamamatsu, Japan, with C. Stark, D. C. Sun, P. Pereira, G. Schmidig, A. Wang and J. H.

Dumbleton.

18. Oxidative behavior and morphological change in gamma irradiated Hylamer, 45th Annual

Meeting, Orthopaedic Research Society, February 1-4, 1999, Anaheim, California, with D. C. Sun,

A. Bellare, C. Stark, and J. H. Dumbleton.

19. Interlaboratory validation of a standard for determining the oxidation index of UHMWPE, 45th

Annual Meeting, Orthopaedic Research Society, February 1-4, 1999, Anaheim, California, with S.

M. Kurtz, O. K. Muratoglu, L. Mounib, B. Currier, R. Gsell, B. Hastings, F-W. Shen, and C. Urian.

20. Interinstitutional reproducibility of standard accelerated aging methods for UHMWPE, 46th

Annual Meeting, Orthopaedic Research Society, March 12-15, 2000, Orlando, Florida, with R.

Gsell, F. Buchana, B. Currier, K. Greer, G. Gualtieri, R.Johnson, S. Shaffner, K Sevo, F. Shen and

S. Spiegelberg.

21. Effect of gamma sterilization in air and shelf aging on wear of “Enhanced” and conventional

UHMWPE cups, 46th Annual Meeting, Orthopaedic Research Society, March 12-15, 2000,

Orlando, Florida, with A. Essner, G. Schmidig and A. Wang.

22. Virgin UHMWPE is not immune to oxidation: a useful feature of accelerated aging?, 47th

Annual Meeting, Orthopaedic Research Society, February 25-28, 2001, San Francisco, California,

with A. Edidin, M. Herr, J. Muth, and S. Kurtz.

23. Gamma-irradiation sterilization in nitrogen improves mechanical properties of highly

crosslinked polyethylene, 49th Annual Meeting, Orthopaedic Research Society, February 2-5, 2003,

New Orleans, Louisiana, with A. Wang.

24. Melt-quenching vs. below-melt annealing: consequences on mechanical properties of radiation

crosslinked UHMWPE, 49th Annual Meeting, Orthopaedic Research Society, February 2-5, 2003,

New Orleans, Louisiana, with A. Wang.

25. Analysis of a retrieved UHMWPE acetabular cup crosslinked in air with 1000 kGy gamma

radiation, J. Ortho. Res., 22, 2004, with N. Sugano, M. Saito, T. Yamamoto, T, Nishi and A. Wang.

26. Reducing hip wear without compromising mechanical strength: a next generation cross-linked

and annealed polyethylene, 5th Combined Meeting of Orthopaedic Research Societies of USA,

Canada, Japan and Europe, October 10-13, 2004, Banff, Alberta, Canada, with A. Essner, G.

Schmidig, A. Wang, J. H. Dumbleton, M. Manley and P. Serekian.

27. Sequential irradiation annealing: a process for the next generation of highly crosslinked

polyethylene, 5th Combined Meeting of Orthopaedic Research Societies of USA, Canada, Japan

and Europe, October 10-13, 2004, Banff, Alberta, Canada, with A. Wang, A. Essner, M. Manley

and J. H. Dumbleton.

28. Sequentially crosslinked and annealed UHMWPE knee wear debris, 51st Annual Meeting,

Orthopaedic Research Society, February 20-23, 2005, Washington DC, with A. Essner, L. Herrera,

A. Wang, J. H. Dumbleton and M. Manley.

29. Acetabular liner functional fatigue performance of crosslinked UHMWPE, 51st Annual

Meeting, Orthopaedic Research Society, February 20-23, 2005, Washington DC, with A. Essner, L.

Herrera, A. Wang, J. H. Dumbleton and M. Manley.

30. Sequentially crosslinked and annealed UHMWPE CR knee wear, 51st Annual Meeting,

Orthopaedic Research Society, February 20-23, 2005, Washington DC, with A. Essner, L. Herrera,

A. Wang, J. H. Dumbleton and M. Manley.

31. Hip wear performance of next generation cross-linked and annealed polyethylene, 51st Annual

Meeting, Orthopaedic Research Society, February 20-23, 2005, Washington DC, with A. Essner, G.

Schmidig, L. Herrera, A. Wang, J. H. Dumbleton and M. Manley.

32. Sequentially crosslinking and annealing increases UHMWPE contact fatigue strength, 51st

Annual Meeting, Orthopaedic Research Society, February 20-23, 2005, Washington DC, with H.

Zeng, A. Essner. A. Wang, J. Dumbleton and M. Manley.

33. Sequentially irradiation and annealing of highly crosslinked polyethylenes: resist oxidation

without sacrificing physical/mechanical properties, 51st Annual Meeting, Orthopaedic Research

Society, February 20-23, 2005, Washington DC, with A. Wang, A. Essner, M. Manley and J. H.

Dumbleton.

34. Wear, oxidation and mechanical properties of a sequentially irradiated and annealed UHMWPE

in total joint replacement, J. Phys. D: Appl. Phys., 39, 2006, with A. Wang, H. Zeng, A. Essner, M.

Manley and J. H. Dumbleton.

35. Critical properties and wear Performance of 1900 direct compression molded versus

crosslinked UHMWPE, 53rd Annual Meeting, Orthopaedic Research Society, February 11-14,

2007, San Diego, California, with P. Lancin, A Essner, A. Wang and T. Schmalzried.

36. Improve strength of crosslinked UHMWPE without compromising oxidation/fatigues

resistance and wear, 6th Combined Meeting of Orthopaedic Research Societies of USA, Canada,

Japan and Europe, October 21-24, 2007, Honolulu, Hawaii, with A. Wang and T. Lovell.

37. Evidence of strength degradation and high free radical intensity in vitamin E-doped irradiated

UHMWPE, 54th Annual Meeting, Orthopaedic Research Society, March 2-5, 2008, San Francisco,

California, with A. Wang and T. Lovell.

38. Evidence of compromised performance properties in vitamin E-doped irradiated UHMWPE, 8th

World Biomaterials Congress, May 28-June 1, 2008, Amsterdam, The Netherlands, with A. Wang

and T. Lovell.

39. A highly crosslinked UHMWPE for CR and PS total knee arthoplasties, J. Arthroplasty, 23-4,

2008, with A. Wang, A. Essner, L. Herrera, M. Manley and J. H. Dumbleton.

40. The effect of neutron radiation on conventional and highly cross-linked ultrahigh-molecular-

weight polyethylene wear, J. Arthroplasty, 23-5, 2008, with D. Markel, S. Mendelson, M. Yudelev,

A. Essner and A. Wang.

41. Real-time shelf aging of sequential crosslinked and annealed UHMWPE, 55th Annual Meeting,

Orthopaedic Research Society, February 22-25, 2009, Las Vegas, Nevada, with K-P. Le, J. Blitz

and J. H. Dumbleton.

42. Anthocyanin doped UHMWPE: oxidation, wear and mechanical properties, 55th Annual

Meeting, Orthopaedic Research Society, February 22-25, 2009, Las Vegas, Nevada, with S. He, K-

P. Le, J. Blitz, L. Korduba and A. Wang.

43. Doping Vitamin E by diffusion deteriorates properties of crosslinked UHMWPE: verified by

experiments, 55th Annual Meeting, Orthopaedic Research Society, February 22-25, 2009, Las

Vegas, Nevada, with K-P. Le and A. Wang.

44. Vitamin E diffusion process elevates remelting of irradiation crosslinked UHMWPE, Annual

Meeting, Society for Biomaterials, 2009, with K-P. Le, J. Blitz and J. Dumbleton.

45. Re-melting occurred in highly cross-linked UHMWPE during sub-melt annealing process, 56th

Annual Meeting, Orthopaedic Research Society, March 6-9, 2010, New Orleans, Louisiana, with

K-P. Le and N. Dong.

46. How does thermal treatment affect the wear characteristics of radiation-crosslinked UHMWPE

with or without vitamin E?, 58th Annual Meeting, Orthopaedic Research Society, February 4-7,

2012, San Francisco, California, with L. Herrera, K-P. Le, J. Longaray, L. Song, T. Davisson and

A. Wang.

47. Basis of a wear resistant highly crosslinked UHMWPE with enhanced fracture toughness, 9th

World Biomaterials Congress, June 1-5, 2012, Chengdu, China, with K-P. Le, L. Korduba and L.

Herrera.

48. Can we trust oxidation measurement in retrieved UHMWPE?, 59th Annual Meeting,

Orthopaedic Research Society, January 26-29, 2013, San Antonio, Texas, with K-P. Le, J.

Longaray, C. Aponte, L. Herrera, L. Song and A. Essner.

49. Macromolecular and morphological characterization of medical grade PEEK polymers, 1st

International PEEK Meeting, April 24-26, 2013, Philadelphia, Pennsylvania, with A. Bellare, K-P.

Le and S. Spiegelberg.

LANGUAGES:

English, Chinese (Mandarin)

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