The FDA Group's Consultant Finder

078

Written by The FDA Group | Sep 23, 2022 4:43:44 PM

EXPERIENCE

Industry Consultant, Consulting Firm 07/2011 - present

Consulted for a variety of clients, including:

  • Medela (McHenry, IL)

Developed unit and system tests for new breast pump.  Wrote several requirements documents. Coordinated software V&V subcontractors.

  • Cerus (Concord, CA)

Revised software design and C++ code on the UVA blood pathogen product previously developed jointly with Baxter. Wrote test procedures, reviewed execution by testers, modified SRS in DOORS Next Generation, analyzed defects.

  • United Technologies (Rockford, IL)

Developed Orion spacecraft simulation detailed requirements.  Developed graphical simulation of spacecraft electronics in Python.  Wrote automated test software in C++ and TCL. Migrated defense system requirements into DOORS.  Modified system requirements in DOORS for Boeing 787.

  • Hospira (Lake Forest, IL)

System engineer assigned to remediation and development of design controls.

  • Metrom (Lake Zurich, IL)

Wrote C software for a hospital patient warming device. Wrote specifications and supervised system testing for railroad safety equipment projects.  Wrote product development process.  Contributed to proposals and patent applications.

  • Intermatic (Spring Grove, IL)

Refactored C software for a lighting controller.

  • Trane (Tyler, TX)

Maintained C++ software for a touchscreen climate controller.

  • Global Product Development (Northbrook, IL)

Provided business development consulting and managed a software developer.

BIT 7 Inc., Mundelein, IL 03/2007 - 03/2011

Supervised renovation of facility (7000 sq ft) and contents.  Apprenticed under outgoing president and assumed that role in 2008.  Continued involvement in project management and software maintenance.  Managed all financial and administrative functions, including corporate taxes and payroll.  Assisted in sales, including proposal writing and customer visits. Managed a number of projects, and participated as a technical contributor when FDA expertise was required.  Handled the varied managerial tasks that come with running a small business, e.g. legal matters, shareholders, facilities, personnel, subcontractors, vendors, etc.

Principal, LTR Inc. 02/1998 - 03/2007

Consulted for a variety of clients, including:

  • Baxter Healthcare (Round Lake, IL)

Participated in multiple projects for Transfusion Therapies, Clintec, and Fenwal divisions.  Designed ClearQuest issues tracking process.  Authored product definition and system requirements documents. Coordinated unit test process improvement group.  Led a team of 9 pharmacists and testers to validate intravenous nutrition software.  Internationalized C++ infusion pump software.  Served on multiple software defect review boards.  Spent a year as acting R&QE representative.  Developed C++ software

for several products.  Software Lead for a team of 8 developers on UVA blood pathogen product. Wrote and executed numerous test plans.  Developed and validated automated test tools.

  • Software Cycles (Cary, IL)

Performed requirements analysis, design, code review, and unit test activities on various projects.

  • BIT 7 (Mundelein, IL)

Developed engineering SOPs and wrote a number of project specifications.  Developed C++ control software and GUI for a Class II medical device.  Project manager for two other medical product development efforts, including verification testing.

  • Siemens Medical (Hoffman Estates, IL)

Redesigned, documented, developed, and integrated image transfer server processes in C++ on a QNX workstation for a nuclear imaging system.

Aksys, Ltd., Lincolnshire, IL 05/1995 - 07/1997

Created software development, QA, and V&V plans and standards.  Authored two revisions of the PHD system requirements and the original draft of the instrument requirements. Moved to the quality department 1/97, as Sr. Principal Software Quality Engineer. Recruited and supervised three software test engineers; developed policies and procedures governing software quality and test; analyzed national and international regulations and formulated compliance approach.

contract at Motorola Cellular Infrastructure Group, Arlington Heights, IL 03/1995 - 05/1995

For the EMX2500 cellular telephone switch: Maintenance and lab testing of C fault management software.

contract at Cummins Electronics, Columbus, IN 05/1993 - 10/1994 For the MRE (mid-range engine) engine control program: Designed classes using Booch object-oriented methodology; developed diesel engine control software in C++ for the pSOS RTOS; developed C++ unit test library with associated UNIX makefiles and scripts.

contract at Bendix, South Bend, IN 02/1993 - 03/1993 Devised test vectors to validate control algorithms. Massive group effort (six weeks, 30+ engineers) to certify FADEC in time for a flight test deadline.

contract at Magnavox Electronic Systems Company, Ft. Wayne, IN 02/1992 - 11/1992 Designed algorithms for artillery aimpoint and effects calculation.  Developed C software to convert TACFIRE V10 messages from variable to fixed format; also programmed data entry menus and databases.  Edited first draft of Software Functional Description document.

contract at Command System Inc., Ft. Wayne, IN 10/1990 - 12/1991 For the MTACCS (Marine Corps Tactical Command and Control System) program, FDS-1 release: Helped design the class hierarchy using CRC object-oriented methodology. Developed a portion of the classes in C++.

Telos Federal Systems, Ft. Wayne, IN 06/1988 - 09/1990 Wrote two proposals and supported software engineering improvement program.  Redesigned and extended tracking software in Ada.  Developed simulation scenario generator. Integrated the tracking and scenario software to form a complete electronic warfare simulation testbed.

Software Consulting Specialists, Ft. Wayne, IN 06/1986 - 06/1988 Developed a prototype CASE tool for object-oriented design, taught an in-house Ada course, and co-authored three SBIR proposals.  Designed and programmed a menu-driven operator interface in Ada. Created an Ada- callable math library in 8087 assembler.  Developed tracking software for electronic warfare.

 

EDUCATION

MBA, management concentration

Saint Francis College, Fort Wayne, Indiana, 1990 BS, Economics & Computer Science (double major)

Rose-Hulman Institute of Technology, Terre Haute, Indiana, 1986