Experienced leader, mentor, and manager with a unique combination of strong technical expertise, business acumen, and excellent interpersonal and communication skills. Pragmatic approach to management with a focus on cross-functional collaboration, execution, and achieving goals. Over 25 years of hands-on experience in research and development for medical devices and scientific instrumentation in diverse markets. Eleven patents.
INFINITE BIOMEDICAL TECHNOLOGIES, Baltimore, MD (1/2006 - present)
Technology development organization focused on translation of fundamental research (neurological signal acquisition and processing) into commercial products.
VP Research and Development - Responsible for research, development, clinical evaluation, and commercialization of neurodiagnostic technologies. Enable product development and drive commercialization of the companys technologies while managing execution of existing grants within budget and schedule constraints. Principal Investigator for multiple SBIR grants.
Established product development processes and a quality management system in accordance with US and international medical device regulations. Created a product portfolio strategy to align business goals with current and future projects. Accelerated product realization by bringing a market-driven focus to the research and development process.
Completed development of the companys first commercial product and achieved 510(k) market clearance in my first 24 months with the company.
Improved grant execution and research data quality through regular status reviews, improved team communication, and a focus on both methods and goals. Instrumental in raising over $5M in grant revenue.
THE JOHNS HOPKINS UNIVERSITY, Baltimore, MD (1994 - present)
Lecturer (part-time), Center for Leadership Education
GE HEALTHCARE, MATERNAL AND INFANT CARE, Laurel, MD (8/2004 12/2005)
Project Manager (through Adecco Technical) - Responsible for the implementation of a new, multi-site product data management (PDM) system; worked with teams in the US and Finland
Successfully developed and implemented a strategy for integrating the new PDM tools with corporate-wide product development processes and the new Enterprise Resource Planning (ERP) system. Lead the conversion of existing paper-based procedures to those utilizing electronic documents and signatures.
Coordinated preparation and loading of existing product data (18k+ items), improving integrity and accuracy. Lead multi-site system testing and user training.
XXXXXXX ASSOCIATES, Baltimore, MD (1/2003 7/2004)
Product development and business consulting; mentor/advisor to startup and emerging technology companies
Engineering services company (3D measurement and modeling) - Created a rapid estimation and project tracking system, increasing project flow and improving customer responsiveness. Designed interactive educational materials that demonstrated the value of company services while improving customer satisfaction.
Dental products start-up Explored options for prototyping and testing
Homeland security start-up Helped clarify business strategy through product definition
METASENSORS, INC., Rockville, MD (8/2001 1/2003)
Venture capital funded start-up company. Manufacturer and OEM supplier of respiratory monitoring/analysis products for critical care applications based on proprietary microfluidic gas analysis technology. Company closed due to loss of funding after September 11, 2001.
Vice President of Operations - Responsible for engineering, R&D, and manufacturing; including creation and execution of product research and development strategies. Senior technical officer and point of contact for investors and partner organizations.
Focused R&D activities on validating critical aspects of the companys core technology platform. Exposed and eliminated a long-standing technical flaw, achieving the accuracy and performance necessary for a marketable product.
Worked with regulatory personnel to prepare the required technical documentation for a Device Master File (MAF) regulatory filing.
IGEN INTERNATIONAL, INC. (now BioVeris/Roche), Gaithersburg, MD (2/2000 7/2001)
Biotechnology company developing instrumentation, assays, and reagents for the life sciences, industrial, and clinical marketplace, based on a proprietary electrochemical detection method.
Director of Engineering, Clinical Diagnostics - Managed all aspects of engineering associated with the development of diagnostic instrumentation for research and clinical applications.
Extended the use of core technology into new markets through the development of a single instrument platform with market/application specific software. These instruments are now sold into the biodefense, life science, industrial and research markets.
Achieved significant improvements in reliability and manufacturability of the companys principal product by developing and instituting in-process metrics and validation systems.
CARDIOLOGIC SYSTEMS, INC., Baltimore, MD (1/1994 9/1999)
Venture capital funded start-up company. Manufacturer of automated systems for cardiopulmonary resuscitation and cardiac assist. Company acquired in September 1999 by Revivant Corporation and subsequently closed.
Senior Vice President & Chief Technical Officer (1999) - Responsible for developing and executing product development strategies and enhancing core company technologies
Led the development of a prototype portable CPR system, achieving reductions in weight of 75% and cost of 50% from previous hospital models.
Worked with medical and scientific advisors to create a clinical trial strategy for regulatory approval of the portable VEST-CPR system.
Acting President (1998 - 1999) - Assumed leadership of the company following staff reductions and departure of former President and CEO.
Reduced operational costs by 30% and implemented measures to preserve capital for ongoing clinical investigations.
Maintained ISO 9001 certification despite significant staff reductions and leadership transition.
Obtained an Investigational Device Exemption (IDE) for a feasibility human clinical trial of a noninvasive cardiac assist device.
Vice President of Operations (1996 - 1998) - Responsible for expanding the engineering and manufacturing organization and facilities to support new product development and manufacturing.
Led the development of VEST-CPR systems from concept through European market launch. Achieved UL/CSA/CE Mark certification of multiple domestic and international models in three years.
Obtained a $450k SBIR grant from NIH for development of a portable VEST-CPR system
Received three US and two foreign patents in five years.
Director of Engineering and Manufacturing (1994 - 1996) - Responsible for the overall engineering of VEST-CPR systems and production and validation of systems to support clinical trials.
Championed the creation, writing, and implementation of the corporate Quality Management System and Design Control Procedures; received ISO 9001 certification in nine months.
Led the design, manufacturing, and verification and validation of VEST-CPR systems for clinical trials. Prepared technical documentation to support a successful IDE application.
THE JOHNS HOPKINS APPLIED PHYSICS LABORATORY, Laurel, MD (6/1983 1/1994)
Research and development laboratory providing technical, engineering, system design, and manufacturing services to the U.S. Navy, NASA, and other government agencies.
Group Supervisor - Mechanical Services, Technical Services Department (1993 - 1994)
Group of 54 providing high quality and responsive services to Laboratory and external customers in the following areas: computer-aided-design and engineering analysis; mechanical fabrication; composite materials design, analysis, and fabrication; and materials laboratory services.
Section Supervisor - Electronic Packaging and Engineering Analysis (1991 1993)
Supervisor of five engineers in the design and analysis of electronic and mechanical systems for spacecraft and shipboard applications.
Research Fellow - The Johns Hopkins School of Medicine (1990 1991)
Investigated the measurement of cardiac muscle mechanical properties through nonlinear finite element modeling.
Section Supervisor - Mechanical Analysis and Design (1987 1990)
Supervisor of ten engineering designers and engineers providing design and analysis services to Laboratory projects. Led the conversion from manual drafting to computer-aided-design; promoted solids modeling for conceptual design and analysis.
Associate Engineer - Engineering Design Group (1983 1987)
Provided design and analysis assistance for Laboratory programs. Participated in collaborative biomedical research with physicians from The Johns Hopkins Medical Institutions. Promoted to Senior Professional Staff in 1987.
Member - JHU/APL Biomedical Devices Committee (1983 1994)
Acted as technical advisor to the Johns Hopkins Hospital Joint Committee on Clinical Investigations.
THE BLACK & DECKER MANUFACTURING CO., Towson, MD (6/1979 6/1983)
Start-up division developing cordless instruments for orthopedic surgery. Participated in development through market launch of a full suite of surgical instruments and cast removal systems.
Education
THE JOHNS HOPKINS UNIVERSITY, Baltimore, MD
Ph.D. in Mechanical Engineering - 1993 (1994 diploma)
Dissertation: Indentation of Finite Thickness Hyperelastic Materials: A Parametric Investigation with Implications for Myocardium
RENSSELAER POLYTECHNIC INSTITUTE, Troy, NY
M.S. in Mechanical Engineering - 1979
Thesis: The Effects of Axial Tension on Korotkoff Sounds
B.S. in Biomedical Engineering - 1978
Professional Activities
American Society of Mechanical Engineers (ASME) Executive Committee, Baltimore Section
Education
THE JOHNS HOPKINS UNIVERSITY, Baltimore, MD
Ph.D. in Mechanical Engineering - 1993 (1994 diploma)
Dissertation: Indentation of Finite Thickness Hyperelastic Materials: A Parametric Investigation with Implications for Myocardium
RENSSELAER POLYTECHNIC INSTITUTE, Troy, NY
M.S. in Mechanical Engineering - 1979
Thesis: The Effects of Axial Tension on Korotkoff Sounds
B.S. in Biomedical Engineering - 1978
Professional Activities
American Society of Mechanical Engineers (ASME) Executive Committee, Baltimore Section
Product Development & Management Association (PDMA) Executive Committee, Baltimore Section
FIRST Robotics Competition - Head Referee
Patents:
Belt with detachable bladder for cardiopulmonary resuscitation and circulatory assist
Belt with detachable bladder for cardiopulmonary resuscitation and circulatory assist
Detection apparatus
Cardiac assist method using an inflatable vest
Cardiac assist method using an inflatable vest
Cardiopulmonary resuscitation system with centrifugal compression pump
Vest for cardiopulmonary resuscitation and assist
Cardiopulmonary resuscitation system with centrifugal compression pump
Vest design for a cardiopulmonary resuscitation system
Wheelchair toileting module and method
Low-voltage surgical cast cutter with vacuum exhaust of debris |
