Medical Device Mechanical

Objective

Position at senior/managerial level in a medical device company with responsibilities for leading and directing the work of subordinate researchers and technicians of a multidisciplinary team and, for implementing and supervising research and development projects concerning mechanical testing, materials performance and development. Eventually leading to managing companywide research and development programs and activities.

Develop test capabilities to support R&D and production test requirements, enhance current products and develop new technologies and products.

Transfer and implement material and technologies from other industrial applications to medical device R&D.

AREAS OF EXPERTISE:

• Biomaterials and materials engineering.

• Biomechanics of joint replacement (hip and knee), spine and masticatory function (dental implants).

• Design, development and implementation of tests for the evaluation of marketed and innovative medical devices (tribological, mechanical, corrosion, wear debris characterization).

• Orthopaedic implant failure analysis (hip, knee, intervertebral disc, spine stabilization devices).

• Failure analysis of metal alloys, monolithic ceramics, polymers and composites components.

• Evaluation of the degradation of biomaterials in simulated biological environment.

• Non-destructive material characterization techniques (Scanning Electron Microscope, XPS, AAS, Acoustic Emission, Thermography, Profilometry, Coordinate Measuring Machine).

• Familiarity in interpreting ISO and ASTM standards.

• Active participation in ASTM Committee F04 on Medical and Surgical Materials and Devices.

RELATED COMPETENCIES:

• Managing people

• Developing creativity in others

• Strong Communications

• Planning, Budgeting, and Organizing

• Innovative Problem Solving

• Resourcefulness

• Results-Oriented

About me

Nine years of experience in orthopaedic devices research, five of which as director of a newly created laboratory that has reached international recognition. A results-driven materials engineer experienced leading the design, development, and implementation of successful projects with surgeons, academic and industrial partners.

Extensive qualifications balanced in all facets of project life-cycle development from initial scientific review, feasibility analysis and conceptual design, budgeting, implementation, testing, data analysis, data review, reporting and publishing.

Strong ability to build, motivate, and develop multidisciplinary teams to achieve remarkable goals. Proactive, nimble, and solutions-oriented, fast learner and enthusiastic.

Significant Qualifications

• Project Leadership – Demonstrated success in leading teams. Clearly communicates direction and inspires team cohesion.

• Project acquisition – demonstrated ability to obtain contracts and funds from industrial partners, foundations and agencies.

• Managing business relation and communication with industrial partners.

• Strategic planning of future line of research.

• Develop and implement podium and publication strategy, clinical education of scientific content, literature reviews and translation/interpretation of clinical data.

EXPERIENCE AND ACHIEVEMENTS

Orthopaedic Hospital & UCLA – Los Angeles, CA 2006 - present

Director of the Biomaterials, Ions and Particles Analysis Laboratory

JVL Orthopaedic Research Center, Department Orthopaedic Surgery, David Geffen School of Medicine at UCLA

Responsibilities:

Develop and manage expense budgets and spending.

Develop a new research plan and publication strategy for the laboratory.

Obtain contracts and funding from orthopedic industrial partners, foundations and agencies.

Provide technical and managerial support for research and product testing with industrial partners.

Manage the workload of personnel and research schedule to meet the contract’s obligation.

Direct and supervise the work of PhD and graduate students.

Direct the selection of new laboratory equipment.

Report directly to Director of Research.

Accomplishments:

Select and build a team internationally awarded with the 2011 John Charnley Award, The Hip Society.

Establish the laboratory as a reference in the field among industry and peers.

Developed new/innovative protocols for debris isolation from wear tests, tissues and synovial fluids.

Developed new protocols for failure analysis of implants and components.

22 publications (peer reviewed and international conference proceedings).

Orthopaedic Hospital & UCLA – Los Angeles, CA 2002 - 2006

Post-doc - Implant Biomechanics Laboratory (Dr. Eddie Ebramzadeh, PI).

Responsibilities:

Develop test programs, protocols and equipment necessary to complete the project.

Manage calibration, safety, maintenance and efficient utilization of testing equipment.

Accomplishments:

Design and construct of a novel orthopaedic wear-testing simulator for a new artificial intervertebral disk prosthesis (research project funded by an industrial partner).

Development of new wear-testing protocol for specimen preparation, loading, and intermittent and final surface and specimen characterization.

Modification of orthopaedic implant fretting wear simulator to create cross-path motion, characteristic of in vivo wear patterns. Studies included a comparative analysis of the differences in modular total knee replacement backside wear of UHMWPE as a function of metal alloy, surface finish, and micromotion (research project funded by an industrial partner).

Fretting wear studies on PMMA cement pins against stems with different surface finishes (collaboration with industrial partner).

European Commission (EC) - Joint Research Centre (JRC) 1995 - 2001

Researcher, Institute for Health and Consumer Protection (IHCP).

Responsibilities:

Member of the Scientific Committee in charge of establishing research and publication strategy for the Institute, and contributing to the development of the necessary consensus for the establishment of European standards through harmonizing methods, benchmarking and identification of best practices.

Responsible for selection of new equipment to set-up wear, mechanical, corrosion and non-destructive testing labs for application to biomaterials and medical devices studies.

Responsible to direct and coordinate the work of research scientists and technicians and to report directly to the Unit Supervisor.

Responsible for research projects and contacts with outside partners such as Hospitals, Research Labs, Universities and Medical Device Companies.

Accomplishments:

Study of a new oxide layer to improve the osseo-integration of metal alloys (EC-JRC-IHCP, Patent No. WO 03/006080 A1).

Study of the tribological behavior of hip prostheses, particularly UHMWPE through conventional and nuclear trace analysis (Thin Layer Activation) techniques.

Design and realization of a new six-station wear simulator.

Application of advanced polarographic techniques and Thin Layer Activation (radionuclide) to study metal ion release from alloys employed in dental and orthopaedic prostheses (stainless steel, Ti alloy, CoCr alloy, Ni-Ti alloys, amalgams, noble and non noble dental alloys).

Study of the corrosion behavior in different physiological-simulated solution.

Development of a new mechanical test on Brånemark-type dental implants and subsequent monitoring of their mechanical behavior by Acoustic Emission Technique.

Consultant to Vallen-Systeme GmbH for Acoustic Emission Instrumentation. Support for new customers and selling. Accomplishment: sold four complete Acoustic Emission Systems, for a total amount of more than 220.000 Euros.

Responsible for the organization and teaching of the preparatory course for Level II certification in Acoustic Emission Testing, Lucchini S.p.A (Steel Manufacturer Company), Lovere, BG (Italy).

EDUCATION

2000 PhD in Materials Engineering, University of Rome "La Sapienza", Italy, with specialization in Biomaterials and Biomechanics.

1995 Laurea in Chemical Engineering (equivalent to Master of Science, 5 years Degree; GPA: 3.6/4.0), with specialization in Materials Engineering, University of Rome "La Sapienza". Final grade: 110/110.

CREDENTIAL, PATENTS and PUBLICATIONS

Patent: Biomedical Titanium Implants (Patent No. WO 03/006080 A1).

Various publications on peer reviewed journals, national and international congresses (available upon request).

Editorial Board: Journal of Applied Biomaterials and Biomechanics (JABB), Orthopedic and Muscular System

Reviewer: Acta Biomateralia, Acta Orthopaedica; Biomaterials; eCells & Materials Journal; Journal of Applied Biomaterials and Biomechanics; Journal of Biomedical Materials Research Part A; Journal of Biomedical Materials Research Part B: Applied Biomaterials; Journal of Engineering Tribology; Journal of Mechanical Engineering Science; Journal of Nanomaterials; Journal of Sports Engineering and Technology; Proceedings of the Institution of Mechanical Engineers Part H; Journal of Engineering in Medicine; Journal of Orthopaedic Research; Clinical Orthopaedics and Related Research.

Member: Society for Biomaterials, European Society for Biomaterials (ESB), Materials Research Society, Orthopaedic Research Society, American Association for the Advancement of Science (AAAS), American Society of Metals (ASM), ASTM International, Italian Society for Biomaterials (SIB), Italian Society for Biomechanics in the Orthopaedic and Traumatological Field (SIBOT), Italian Association of Materials Engineering (AIMAT), Italian Professional Engineers Association.

AWARDS and SCHOLARSHIPS

2011 John Charnley Award, The Hip Society.

2011 Lloyd Taylor Award, The Western Orthopaedic Association.

2008 June Marshall Award – Exemplary Achievement in Orthopaedic Research.

2004 Orthopaedic Hospital Scientific Paper Award.

2002 and 2003 Eleanor Berry Fellowship - Orthopaedic Hospital.

1998 - 2001 Marie Curie Fellowship - European Commission – Joint Research Centre.

1996 - 1999 Doctorate Fellowship - Università di Roma “La Sapienza” - Italy

LANGUAGES

Italian Native.

English Spoken and written excellent.

French Spoken and written fair.

COMPUTER SKILLS

Windows, Office Suite, Solid Works, SPSS, TestStar, MeX.

US STATUS

Permanent Resident.

Web Pages

LinkedIN Profile: http://www.linkedin.com/pub/fabrizio-billi/3/369/a01

Web Pages: http://ortho.ucla.edu/body.cfm?id=138 and www.orthopaedicparticleanalysis.com

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