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AREAS
OF EXPERTISE
Medical
Device Industry - Regulatory: Lead scientific reviewer
for IDE, 510k, and PMA documents related to drug-eluting stents,
atherectomy devices, various balloon catheters and other diverse
cardiovascular medical devices. Vast majority of work involves
IDE and pre-IDE reviews for coronary and peripheral devices.
Provide technical input on various guidance documents and
ASTM standard committees.
Manufacturing:
Experience in standard shop practices such as welding, milling,
lathe work and non-destructive evaluation in addition to CAM
using SurfCam software. Experience using the lost wax casting
process and other common casting processes.
Clinical
Laboratory Practices: Skilled in standard clinical lab
processes such as pipetting, spectrophotometry, slide preparation,
centrifugation and handling biological (blood) tissues.
Areas
of Biomedical Expertise: Heat and mass transfer in biological
systems, ablation/cauterization of tissue, measurement/modeling
of epidermal water loss, anesthesia induced hypothermia, biomechanics/measurement
of human gait/activity, instrumentation for human interface,
low dosage x-ray equipment for human use, modeling of bone
tissue adaptation, hip implant design/modeling, hemolysis
(red blood cell damage) in medical devices, cardiopulmonary
by-pass (CPB) roller pump occlusion setting procedures, blood
testing/experimentation procedures, intercranial pressure
and the cerebral spinal fluid (CSF) system, functional electrical
stimulation (FES) for spinal cord injuries (SCI), wheelchair
function/design, issues of daily living with SCI, anthropomorphic
sizing of equipment for human use, medical device and blood
flow interactions.
EDUCATION
| Ph.D. |
Biomedical
Engineering, University of Virginia (2000) |
| M.S. |
Mechanical
Engineering, Thermosciences, Stanford University (1992) |
| B.S. |
Mechanical
Engineering, University of Connecticut (1988) |
EXPERIENCE:
CURRENT
POSITION:
Apr. 2008- Present |
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Senior
Consultant, Biologics Consulting Group, Inc.
Sunnyvale, CA.
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| winter
and spring quarters 2008 |
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Part-time
faculty, Mechanical Engineering Department, Santa
Clara University, Santa Clara, CA.
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Developed and taught new courses called Comparative
Biomechanics I: Fluids and Comparative Biomechanics
II: Solids and Structures.
- Courses
focued on the application of engineering principles
to the physical world.
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| Aug.
2006 - Mar. 2008 |
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Mechanical/
Biomedical Engineer, Boster, Kobayashi and Associates:
Consulting Engineers and Scientists, Livermore, CA.
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Associate of Boster, Kobayashi & Associates, a
consulting firm specializing in the technical aspects
of accident reconstruction and highway design.
- Typical
assignments involve application of the laws of physics
and principles of biomedical and mechanical engineering
in accident reconstruction, premises liability, and
injury causation.
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| Nov.
2002 - Jul. 2006 |
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Mechanical/Biomedical
Engineer - Reviewer, Interventional Cardiology Devices
Branch, Division of Cardiovascular Devices, CDRH, FDA,
Rockville, MD.
-
Served as a lead medical device reviewer within the
Interventional Cardiology Devices Branch in the Office
of Device Evaluation (ODE) for cardiovascular medical
devices.
- Reviews
predominantly involved pre-IDEs, IDEs, and to a smaller
extent 510k and PMA submittals from the medical device
industry.
- Responsibilities
also involved engineering reviews of drug eluting
stents and standards development for both the Interventional
Cardiology Devices and the Peripheral Vascular Devices
Branches.
- Served
as Primary FDA Liaison to ASTM F04.30.06 Interventional
Cardiology Task Group and as the Task Group Co-Chair.
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| Jun.
2001 - Nov. 2002 |
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ORISE
Post Doctoral Fellow, Hydrodynamics and Acoustics
Branch, Division of Physical Sciences, CDRH, FDA, Rockville,
MD.
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Performed basic research to objectively study the
amount of red blood cell damage (hemolysis) caused
by medical devices in order to better predict hemolysis.
- One
type of device under study was the class of roller
pumps used in cardiopulmonary bypass surgery.
- Other
studies involved determination of a reliable bench-top
blood fragility tester.
- Laboratory
studies will be continued into the future and be complemented
with PIV flow visualization and Fluent FEM of several
blood damage models.
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| 2006
spring semester |
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Part-time
Faculty, Mechanical and Aerospace Engineering Department,
George Washington University, Washington, DC.
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Developed and taught a new course for undergraduates
called Biomechanics I focusing on structural biomechanics
in humans
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| 2004
and 2005 spring semesters |
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Part-time
Faculty, Mathematics, Science, Physics and Engineering
Division, Montgomery College, Germantown, MD
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Taught PC 101 - Physical Science class for non-science
majors. Responsible for teaching lecture, discussion
and laboratory sessions.
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| Aug.
1994 - Jun. 2001 |
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Mechanical/Biomedical
Engineer, Musculoskeletal Biomechanics Laboratory,
Life Science Division, National Aeronautics and Space
Administration, Ames Research Center, Moffett Field,
CA.
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Biomedical engineering dissertation research in the
Musculoskeletal Biomechanics Laboratory involving
development of a Ground Reaction Force (GRF) sensor,
direction of associated human research studies, and
investigation of basic aspects of musculoskeletal
remodeling.
- Laboratory
Website Mistress/Developer (http://lifesci.arc.nasa.gov/~rwhalen).
General: Heat transfer analysis and development of
a finite element model using COSMOS/M for a Shuttle
payload.
- Intercranial
Pressure Research: Instituted an improved data acquisition
method within one month.
- Initiated
evaluation of response wave form (amplitude vs. time)
in intercranial pressure.
- Conferred
with regulatory consultant in order to document testing
for future FDA approval.
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| Sep.
2000 - Dec. 2000 |
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Acting
Assistant Division Chief, Life Science Division,
National Aeronautics and Space Administration, Ames
Research Center, Moffett Field, CA.
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Administrative Activities: Represented the Life Science
Division in meetings related to personnel, budget,
projects, promotion and outreach.
- Prepared
reports related to safety, ongoing projects (flight
and ground based) and general information.
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| Aug.
1993 - Aug. 1994 |
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Full-time
Graduate Study Fellowship, Biomedical Engineering
Department, University of Virginia., National Aeronautics
and Space Administration, Ames Research Center, Moffett
Field, CA.
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Completed all course work required for the Ph.D. degree
in Biomedical Engineering.
- Surpassed
school of engineering requirements by passing the
Foreign Language Mastery Exam for Ph.D. candidates
in French.
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| Sep.
1992 - Aug. 1993 |
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Project
Engineer, Human Powered Centrifuge Project, Life
Science Division, National Aeronautics and Space Administration,
Ames Research Center, Moffett Field, CA.
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Led and managed the Human Powered Centrifuge Project.
- Wrote
facility checkout, testing, and operation procedures.
- Scheduled
workflow and established budgets for all phases of
the project.
- Achieved
a reduction in initial project cost estimate (estimated
at over $100,000) by recognizing and instituting a
simpler and more cost effective solution.
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| Nov.
1988 - Sep. 1992 |
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Facility
Engineer, Space Technology and Aeronautical Test
and Simulation Divisions, National Aeronautics and Space
Administration, Ames Research Center, Moffett Field,
CA.
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Experience working in three different test facilities:
Arc-Jet Facilities Complex, 3.5-Foot Hypersonic Wind
Tunnel, 14-Foot Transonic Wind Tunnel.
- Management/General:
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Coordinated and determined facility related equipment
to support model testing.
- Inspected
and documented facility in order to advocate future
funding allocation and planning.
- Coordinated
and monitored various facility projects ($100,000
- $950,000).
- Wrote
facility reports associated with operational readiness
and accident investigations.
- Managed
and directed through shops various facility projects
and upgrades ($5,000 - $10,000).
- Coordinated
engineers from other organizations in investigating
and solving facility problems as appropriate.
- Technical:
- Investigated,
inspected and diagnosed facility shutdown problems
and accidents.
- Determined
tunnel critical electrical devices and analyzed
facility operational logic sequence.
- Performed
various structural and heat transfer calculations.
- Designed
an insert/retract mechanism for an oxygen sensor.
- Calculated
makeup water required for cooling tower operation.
- Selected
various upgrades to facility equipment including
pumps, thermocouples, and valves.
- Special
Project: Directed and managed turning vane set inspection,
evaluation, and repair project ($300,000) including
scheduling and manpower.
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| Jun.
1984 - July 1998 |
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Lab
Assistant, Mechanical Engineering Department, University
of Connecticut, Storrs, CT.
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Assisted graduate student in fluids lab doing research
on optimization of diffusers and turbine endwalls
using the ice-formation method.
- Testing
in water and wind tunnels.
- Applied
Helium bubble and laser induced fluorescent dye flow
visualization techniques.
- Worked
independently to test and organize data on the new
diffusers.
- Worked
with various shop tools and techniques such as the
drill press, and casting the ice-formations with hot
beeswax, plaster and dental material.
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AWARDS
| FDA/CDRH/ODE/DCD
Special Achievement Cash Award of $1000 (Recognition of
ASTM F04.30.06 Co-Chair achievements). 2006. |
| FDA/CDRH/ODE/DCD
Special Achievement Cash Award of $250 and Credit Time
Award of 2 days leave (IDE engineering review related).
2005. |
| FDA/CDRH/ODE/DCD
Special Achievement Cash Award of $500 (IDE engineering
review related). 2005. |
| FDA/CDRH/ODE/DCD
Special Achievement Cash Award of $750 (PMA lead review
related). 2004. |
| FDA/CDRH/ODE/DCD
Special Achievement Cash Award of $500 (IDE lead review
related). 2003. |
| NASA
Ames Research Center Achievement Cash Award of $400. 2000.
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| NASA
Ames Research Center Job Performance Award of $500. 1999.
o NASA Ames Research Center Achievement Cash Award of
$500. 1999. |
| National
Osteoporosis Foundation, Mazess Student Fellowship of
$4000. 1998. |
| NASA
Ames Research Center Achievement Cash Award of $250. 1998.
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| NASA
Ames Research Center Community Day Cash Award of $500.
1997. |
| Engineer
In Training (EIT) Certification for California (Registration
#XE096520). 1995. |
| NASA
Ames Group Achievement Cash Award of $250 Human Powered
Centrifuge Project. 1994. |
| NASA
Ames Full-time Graduate Study Fellowship Award. August
1993 - August 1994. |
| NASA
Ames Group Achievement Award for College Recruiters Adopt-A-School
Program. 1993. |
| NASA
Ames Special Achievement Cash Award of $750. 1989. |
PROFESSIONAL
SOCIETIES
- Society
of Automotive Engineers (SAE), 2006 - Present
- ASTM
Member, 2005- Present
- Primary
FDA Liaison to ASTM F04.30.06 Interventional Cardiology
Task Group and Task Group Co-Chair, 2005 - 2006
- American
Society of Biomechanics (ASB), 1997 - present
- Biomedical
Engineering Society (BMES), 1993 - present
- American
Society of Mechanical Engineers (ASME), 1984 - present
- ASME
Santa Clara Valley Section Website Mistress/Developer, 1996
- 1997; Section Programs Chair, 1996 - 1997; Mentor: ASME
Student Mentorship Program, 1995 - 1996.
PATENTS
|
Patent pending (through Stanford University): Dewpoint
hygrometry system for evaporative water loss in infants. |
PUBLICATIONS
-
Bowley, S.M. and Malinauskas, R.A. (2003). Evaluation of
Parameters Affecting Bovine Blood Hemolysis Testing. Podium
presentation and abstract for the ASME 2003 Summer Bioengineering
Conference, Key Biscayne, FL.
- Malinauskas,
R.A. and Bowley, S.M. (2002). Red Blood Cell Mechanical
Fragility Tester. Abstract for the FDA Science Forum Meeting,
Washington, DC.
- Bowley
S.M., and Whalen R.T. (2001). Physical Activity and Bone
Density in Women. Podium presentation and abstract for ORS
Meeting, San Francisco, CA.
- Bowley
S.M., Breit G.A., and Whalen R.T. (1999). Accuracy of monitoring
peak force and temporal parameters of gait using a capacitance
insole system. Podium presentation and abstract for ASB
Meeting, Pittsburgh, PA.
- Bowley
S.M., Breit G.A., and Whalen R.T. (1998). Objective measurement
of daily human activity. Abstract for ASBMR Meeting, San
Francisco, CA.
- Bowley
S.M., Breit G.A., and Whalen R.T. (1998). Capacitance insole
sensor calibration and performance tests for use in human
activity monitoring. Abstract for ASB/NACOB Meeting, Waterloo,
Ontario, Canada.
- Ariagno
R.L., Glotzbach S.F., Baldwin R.B., Rector D.M., Bowley
S.M., Moffat R.J. (1997). Dewpoint hygrometry system for
measurement of evaporative water loss in infants. J. Appl.
Physiol. 82(3):1008-1017.
- Greenleaf
J.E., Gundo D.P., Watenpaugh D.E., Mulenburg G.M., Marchman
N., Looft-Wilson R., Hargens A.R., and Bowley S.M. (1996).
Cycle-powered short radius (1.9m) centrifuge: Exercise vs.
passive acceleration. Abstract for 17th Annual Gravitational
Physiology Meeting, Warsaw, Poland.
- Torikoshi
S., Ballard R.E., Watenpaugh D.E., Murthy G., Bowley S.M.,
Yost W.T., and Hargens A.R. (1995). Measurement of transcranial
distance during head-down tilt using ultrasound. Abstract
for 16th Annual International Gravitational Physiology Meeting,
Reno, Nevada.
- Bowley
S.M. (1995). The Human Powered Centrifuge Facility at NASA
Ames Research Center. Abstract for AIAA Meeting, AIAA-95-3572.
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Updated:
May 1, 2008
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