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<P><b>Resume of Steven R. Rakitin </b></P> </font>
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<P><FONT SIZE="2" Font Color="Black"><B><u>Summary:</u></P></B></FONT>
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<P><FONT SIZE="2"><P>Software Quality Assurance, Verification &
Validation, Software Development, Process Improvement, Inspections,
Automated Testing, Management, ISO-9000, Medical Device Software
Development Process, FDA QSR, Auditing.</P></FONT>
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<B><P><u>Education:</u></B></P></FONT>
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<FONT FACE="Verdana" FONT SIZE="2">
<LI>BS Electrical Engineering/Power Systems, Northeastern University,
1973<p></LI>
<LI>MS Computer Science, Rensselaer Polytechnic Institute, 1979<p></LI>
<LI>IEEE Software Reliability Seminar, 1991<p></LI>
<LI>ISO-9000 Lead Auditor Training, 1994<p></LI>
<LI>ASQ Certified Quality Auditor (CQA), 1994<p></LI>
<LI>ASQ Certified Software Quality Engineer (CSQE), 1996<p></LI>
<LI>Introduction to the SEI Capability Maturity Model, 1996<p></LI>
</FONT><P>
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<B><FONT FACE="Verdana" FONT SIZE="2" Font Color="Black"><P>
<u>Experience:</u></P></B></FONT><P>
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<td WIDTH="73%" ALIGN=LEFT><FONT FACE="Verdana" Size=2 Color="RED">
<B>Software Quality Consulting, Inc.</B></FONT>
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<FONT FACE="Verdana" Size=2 Color="RED">
<B>1997 - present</FONT></B>
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<FONT FACE="Verdana" SIZE=2><B>President</B>
<P>Established consulting practice focused on helping clients create
Predictable Software Development processes.</P></FONT>
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<B>Viewlogic Systems, Inc.</FONT></B>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>
1996 - 1997</FONT></B>
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<b>Director of Corporate Quality</P></B>
<P>Reporting to the President, I established a corporate Quality function
with overall responsibility for improving Viewlogic's Quality System.
Primary focus on product and process improvements, Customer Satisfaction,
and ISO-9001/TickIT compliance. Coordinated software process improvement
initiatives with software development groups working in both Unix and NT
environments. Managed program for measuring Customer Satisfaction.
Initiated a Supplier Quality program for third party software. Improved
software licensing processes. Provided training to improve effectiveness of
internal testing. Established Viewlogic User Group. Frequent customer
contact.</P></FONT>
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<td WIDTH="80%" ALIGN=LEFT><FONT SIZE="2" FACE="Verdana" Font Color="Red">
<B>Ciba Corning Diagnostics Corp.</FONT></B>
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<TD WIDTH="20%" ALIGN=RIGHT>
<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>1990 - 1996</FONT></B>
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<FONT FACE="Verdana" SIZE="2"><b>Manager of Regulatory Compliance</P></B><p>
<P>Responsible for assessing compliance with FDA GMP regulations and ISO-
9000 standards by performing periodic audits at 5 CCD facilities. Prepared
and submitted 510(k)s for several devices. </P></FONT>
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<FONT FACE="Verdana" SIZE=2><b>Manager of Software Quality
Assurance</b></P></FONT>
<P><FONT FACE="Verdana" SIZE=2><P>Established SQA function for the
R&D organization. Responsible for Software V&V for in-vitro
diagnostic medical instruments and data management products. Actively
participated in software development activities. Provided technical and
administrative management for SQA Group. Developed a Software Engineering
Handbook tailored to needs of business. Developed a similar handbook for
software used in test equipment. Led a cross-functional team in developing
a New Product Development Process encompassing Engineering, Manufacturing,
and Service. </P></FONT>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>GenRad Inc.</FONT></B>
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<TD WIDTH="20%" ALIGN=RIGHT>
<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>1989 - 1990</FONT></B>
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<FONT FACE="Verdana" SIZE="2"><b>Manager of Operating Systems Group
</B></FONT>
<p><FONT FACE="Verdana" SIZE=2>Responsible for developing GenRad
-specific modifications for Ultrix and SunOS to support GenRad's 275x Board
Test product line based on a MicroVAX Fileserver and Sun Workstations.
Developed requirements and high level design for a Unix disk partition
utility using the Quality Function Deployment (QFD) methodology. Developed
test plans for evaluating alpha and beta releases of GenRad's Ultrix and
SunOS.</P></FONT>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>Wang Laboratories,
Inc.</FONT></B>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>1986 - 1989</FONT></B>
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<FONT FACE="Verdana" FONT SIZE="2"><b>Principal Engineer </b></FONT>
<p>
<FONT FACE="Verdana" FONT SIZE="2">
Advanced Workstation (42x) Project. User Interface Team. Developed a common
set of user interface widgets for Wang application developers. Wrote a
functional description of widget features and application program
interfaces. Designed and implemented support functions for several widgets
including icons, paragraph fields, and text integration across
applications.</P>
<P>Distributed Management Facility Project. Project leader for Network
Management product. Reverse-engineered the product and wrote a Functional
Spec and a System Design Spec. The System Design Spec provided the basis
for a cooperative test plan developed with the QA group for testing prior
to first customer ship.</P></FONT>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red">
<B>Telco Systems Fiber Optics Corp.</FONT></B>
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<TD WIDTH="20%" ALIGN=RIGHT>
<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>1985 - 1986</FONT></B>
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<FONT FACE="Verdana" SIZE="2"><b>Principal Engineer</P></B></FONT>
<p><FONT FACE="Verdana" SIZE=2><P>TELTRAC Project. TELTRAC was a menu
-driven, real-time, network monitoring and control application developed
for Telco's telecommunication equipment. Reverse engineered the TELTRAC
product and wrote a complete Functional Spec which served as the basis for
adding new features, developing marketing brochures, and improving customer
training courses. Based on this document, developed a comprehensive System
Integration Test Procedure. Developed a Software Life Cycle Model as part
of Telco's New Product Development Process.</P>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red">
<B>Telos Consulting Services, Inc.</FONT></B>
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<TD WIDTH="20%" ALIGN=RIGHT>
<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>1983 - 1985</FONT></B>
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<FONT FACE="Verdana" SIZE="2"><b>Member of Technical Staff</P></B></FONT>
<p><FONT FACE="Verdana" SIZE=2><P>Assigned to M/A-Com Linkabit, Inc. -
The Dual Modem was a military airborne system that provided network
control protocol and user interface to establish air-to-ground
communications. Designed the user interface and wrote a Detailed Software
Design Specification, including a functional overview, module
descriptions, pseudo-code, and data structure declarations.</P>
<p><FONT FACE="Verdana" SIZE=2><P>Assigned to Millipore Corp. - Waters
Chromatography Division. Designed and implemented screen editors and menus
which allow users to perform Gel Permeation Chromatography for a
Workstation-based product. Designed and implemented a menu-driven user
interface for a Gradient-controller product.</P>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red">
<B>SofTech, Inc.</FONT></B>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>1978 - 1983</FONT></B>
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<FONT FACE="Verdana" SIZE="2"><b>Manager of Software Quality Assurance
</P></B></FONT>
<p><FONT FACE="Verdana" SIZE=2><P>Established SQA function. Provided
technical and administrative management for a group of 8 Software Engineers
who performed Software QA and Configuration Management functions.</P>
<p><FONT FACE="Verdana" SIZE=2><P>Ada Language System Project. Under
contract to the US Army, SofTech developed the first Ada Compiler for the
DoD. Performed detailed technical reviews of high-level and detailed
software design documents for compilers, assemblers, linkers, debuggers,
and database management tools designed by SofTech. Developed an overall
Test Plan and specific Test Procedures for testing the Ada Compiler using
the Ada Compiler Validation Capability Test Suites. Participated in the
development of configuration control and regression testing tools.</P>
<p><FONT FACE="Verdana" SIZE=2><P>ITT Telecommunications Switch
Project (DoD). Responsible for providing an independent technical
assessment of telecommunications software developed by ITT. Reviewed and
evaluated Program Performance Specs, Program Design Specs, Test Plans and
Test Procedures as well as software development practices. Developed and
applied a set of software quality metrics to code written by ITT.</P><p>
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<FONT SIZE="2" FACE="Verdana" Font Color="Red">
<B>Combustion Engineering, Inc.</FONT></B>
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<TD WIDTH="20%" ALIGN=RIGHT>
<FONT SIZE="2" FACE="Verdana" Font Color="Red"><B>1973 - 1978</FONT></B>
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<FONT FACE="Verdana" SIZE="2"><b>Senior Engineer</P></B></FONT>
<p><FONT FACE="Verdana" SIZE=2><P>Developed software for monitoring
critical parameters in nuclear power plant control systems. Developed real
-time control software for a microprocessor-based in-core neutron flux
detector. Prepared requirements for advanced control room designs.</P>
<p><FONT FACE="Verdana" SIZE=2><P>Researched structured software
development methodologies appropriate for developing critical software for
safety-related functions in nuclear power plant control and protection
systems.</P>
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<B><FONT FACE="Verdana" SIZE=2 Color="Black">
<P><u>Professional Affiliations:</u> </P></B></Font>
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<P>IEEE Computer Society</P>
<P>American Society for Quality (ASQ) Software Division</P>
<p>Association for the Advancement of Medical Instrumentation (AAMI) </p><br><p>
<B><FONT FACE="Verdana" SIZE=2 Color="Black">
<P><u>Other:</u></P></B></Font>
<FONT FACE="Verdana" SIZE=2>
<P>Appointed to the Editorial Review Board for Software Quality
Professional, a journal published by the ASQ software Division</P><br><p>
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<P><u>Books, Publications and Presentations:</u></P></Font></B>
<FONT FACE="Verdana" SIZE=2>
<p>"Creating Accurate Estimates and Realistic Schedules", <i>ASQ Software Quality Professional,</i> Vol. 4, No. 2, p. 30-36, March 2002.</p>
<U><P>Software Verification & Validation for Practitioners and Managers</U>, 2nd ed., Norwood, MA: Artech House Inc., 2001.</P>
<P>Management's Role in Achieving Predictable Software Development - Invited tutorial presented at the 11<SUP>th</SUP> ASQ International Conference on
Software Quality, Pittsburgh, PA, Oct 2001</P>
<P>Management's Role in Achieving Predictable Software Development - Invited tutorial presented at the 10<SUP>th</SUP> ASQ International Conference on
Software Quality, New Orleans, LA, Oct 2000</P>
<P>Software Verification & Validation - An Overview for Practitioners - Invited tutorial presented at the 17<SUP>th</SUP> Annual Pacific Northwest
Software Quality Conference, Portland OR, Oct 1999</P>
<p>Software Verification & Validation - An Overview for Practitioners -
Invited tutorial presented at the 1999 Annual Meeting & Expo of the
Association for the Advancement of Medical Instrumentation (AAMI), Boston, MA, June 1999.</P>
<p>"Balancing Time to Market and Quality", <i>Software Quality Professional, </i>Vol. 1, No. 3, June 1999.</P>
<U><P>Software Verification & Validation: A Practitioner's Guide</U>, Norwood, MA: Artech House Inc., 1997.</P>
<P>Software Verification & Validation - An Overview for Practitioners -
Invited tutorial presented at the 15<SUP>th</SUP> Annual Pacific Northwest
Software Quality Conference, Portland OR, Oct 1997</P>
<P>"Revisiting the Software Development Process",<i> Medical Device &
Diagnostic Industry,</i> Vol. 16, No. 5, May 1994, p. 232-236.</P>
<P>"The Economics of Software Process Improvement", Health Industry
Manufacturers Assoc. (HIMA) Conference on Medical Device Software,
Washington DC, May 1994.</P>
<P>"Practical Methods for Cost-effective Verification and Validation of
Medical Device Software", Health Industry Manufacturer's Assoc. (HIMA)
Conference on Medical Device Software Development and Product Submissions,
Washington DC, December 1992.</P>
<P>"Factors Influencing the Software Development Process for In-vitro
Diagnostic Instruments", Assoc. for the Advancement of Medical
Instrumentation (AAMI) 27th Annual Conference; Anaheim, CA, June 1992.</P>
<P>"Experience Performing Software Quality Assurance on the Ada Language
System Project", Proc. IEEE Sixth International Conf. on Software
Engineering; Tokyo, Japan, September 1982.</P>
<P>"Validation of Safety System Software", International Atomic Energy
Agency Specialists Meeting on Software Reliability for Computerized Control
of Safety Systems in Nuclear Power Plants", Pittsburgh, PA, July 1977, co-
author.</P></FONT><br><p>
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