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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
 

Senior Consultant, Biologics Consulting Group, Inc.
Sunnyvale, CA.

 
winter and spring quarters 2008  

Part-time faculty, Mechanical Engineering Department, Santa Clara University, Santa Clara, CA.

  • 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.
 
Aug. 2006 - Mar. 2008  

Mechanical/ Biomedical Engineer, Boster, Kobayashi and Associates: Consulting Engineers and Scientists, Livermore, CA.

  • 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.
 
Nov. 2002 - Jul. 2006  

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.
 
Jun. 2001 - Nov. 2002  

ORISE Post Doctoral Fellow, Hydrodynamics and Acoustics Branch, Division of Physical Sciences, CDRH, FDA, Rockville, MD.

  • 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.
 
2006 spring semester  

Part-time Faculty, Mechanical and Aerospace Engineering Department, George Washington University, Washington, DC.

  • Developed and taught a new course for undergraduates called Biomechanics I focusing on structural biomechanics in humans
 
2004 and 2005 spring semesters  

Part-time Faculty, Mathematics, Science, Physics and Engineering Division, Montgomery College, Germantown, MD

  • Taught PC 101 - Physical Science class for non-science majors. Responsible for teaching lecture, discussion and laboratory sessions.
 
Aug. 1994 - Jun. 2001  

Mechanical/Biomedical Engineer, Musculoskeletal Biomechanics Laboratory, Life Science Division, National Aeronautics and Space Administration, Ames Research Center, Moffett Field, CA.

  • 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.
 
Sep. 2000 - Dec. 2000  

Acting Assistant Division Chief, Life Science Division, National Aeronautics and Space Administration, Ames Research Center, Moffett Field, CA.

  • 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.
 
Aug. 1993 - Aug. 1994  

Full-time Graduate Study Fellowship, Biomedical Engineering Department, University of Virginia., National Aeronautics and Space Administration, Ames Research Center, Moffett Field, CA.

  • 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.
 
Sep. 1992 - Aug. 1993  

Project Engineer, Human Powered Centrifuge Project, Life Science Division, National Aeronautics and Space Administration, Ames Research Center, Moffett Field, CA.

  • 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.
 
Nov. 1988 - Sep. 1992  

Facility Engineer, Space Technology and Aeronautical Test and Simulation Divisions, National Aeronautics and Space Administration, Ames Research Center, Moffett Field, CA.

  • Experience working in three different test facilities: Arc-Jet Facilities Complex, 3.5-Foot Hypersonic Wind Tunnel, 14-Foot Transonic Wind Tunnel.
  • Management/General:
    • 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.
 
Jun. 1984 - July 1998  

Lab Assistant, Mechanical Engineering Department, University of Connecticut, Storrs, CT.

  • 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.

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.
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.
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.

Page Updated: May 1, 2008