Industry Consultant

EDUCATION:

MS in Computer Information Systems with an emphasis in Software Engineering; Grand Valley State University:  December 1993.  Carried a full load of classes while working full-time.  Graduated with a 3.8 GPA out of 4.0.

Bachelor of Arts with majors in English and History; Calvin College:  Grand Rapids, MI (1980 - 1985)

TECHNOLOGY PROFILE:

PROFESSIONAL EXPERIENCE:

Utilis Opus Enterprises, (formerly Software Cycles, Inc.)  Cary,  IL  (96 - Present)

Provide Consulting Services and System and Software Production for a wide variety of regulated industries.  The following list includes Clients and Products provided to each:

Hospira, Inc.   Lake Forest,  IL

Quality System Design Control Developer:

• Led effort to remediate Quality System Design Controls in a 45 day project allowing Hospira to renew their CE certifications
• Developed an Essential Performance Procedure for the implementation of a compliant risk management process per IEC 60601-1 Edition 3.1
• Re-architected, designed, implemented, and provided corporate-wide training for a new Change Management process in 90 days

Lead System Engineer for the Risk Management File Accelerated Remediation project:

• Led multi-discipline team to remediate risk management artifacts for consumable medical devices to address compliance issues raised by various regulatory agencies
• Authored Design Input Requirements and System Architectures for various consumable medical products
• Performed Use Case Analysis against user needs for consumable medical devices

Cerus Corporation. Concord, CA  - Verification Engineer

Participate in software verification of Real-Time Embedded Software for a Blood Product Pathogen Inactivation System

• Analyze Software Requirements
• Plan, Design, and Execute Software Unit Tests
• Write and Execut Software Verification Test Procedures
• Develop Utility to Extract Treatment Records from Instrument and Convert to Human Readable Format

Hamilton Sundstrand, Inc.   Rockford,  IL

Participate in System Development of Actuation System for Slats and Flap Control for Embraer KC390

• Analyze System-Level Change Requests to isolate root cause(s), propose solutions, and implement solutions
• Peer Reviews of Change Requests
• Coordinate Change Requests with Software Engineering

Technical Lead a team of six in the Development of software simulation of electrical components for the Orion Crew Exploration Vehicle

• Develop Software Simulation Requirements from Hardware Requirements using DOORS
• Build Simulation Prototypes of Electronic Boards using Pyton and C++
• Create Object-Oriented UML Design using Rhapsody and implement designs using C++
• Develop and Perform Unit Testing on Implementation

Participate in Software Development of the RPDS Secondary Power Generation Assembly for the Boeing 787 Dreamliner against DO-178B

• Design Power Distribution User Interface and Circuit Breaker Database Software 
• Develop Software Requirements for Operational Manager CSCIs using UML Use Cases
• Create High-Level and Detailed Design for Operational Manager CSCIs using UML

Participate in Software Development of an Embedded Real-Time Electrical Power Distribution System for the Global Express Aircraft for Bombardier against DO-178B

• Process Change Requests through Development Lifecycle
• Review Software Designs and Implementation
• Perform Unit and Domain Testing on CAIMS Software

ZOLL Medical. Long Grove, IL  - Validation Engineer

Participate in validation of Real-Time Embedded Software for a Defibrillation and Health Monitoring System

• Assess Software Requirements
• Write Software Validation Protocols
• Execute Software Validation Protocols

BIT 7 Inc. Mundelein, IL  - Software Engineer

Participate in development of Real-Time Embedded Software for a Medical Gas Delivery System

• Participate in Requirements Definition and Analysis
• Develop Software Architecture and Design using UML for various application level components targeted for the Linux and MicroC operating systems
• Implement and Test components using GNU development tools using C++ in a Linux environment
• Integrate collections of components in simulated and actual hardware target platforms
• Develop and Execute Design Verification and System Verification

Boeing. St Louis, MO  - Software Engineer

Participate in development of Real-Time Embedded Simulation Software to model Aircraft Survivability Equipment for Apache Helicopter to be used in training of UK aircrews.

• Define and Analyze Software Requirements and Develop Traceability using DOORS
• Develop Software Architecture and Design using UML
• Implement and Unit Test using Green Hills development tools using Ada 95
• Perform Hardware/Software Integration in lab environment using Green Hills Debugger and Tornado tools for VxWorks

Baxter Healthcare Corporation. Round Lake,  IL  - Systems Engineering Consultant

Red Blood Cell Pathogen Inactivation System Activities include:

• Write Product Definition and System Requirements

• Perform Requirements Management and Traceability Development utilizing DOORS

• Develop System Architecture Document

• Develop System Test Specification

Pathogen Inactivation UVA Illuminator (UVAID) System Activities include:

• Define and Analyze Software Requirements for the UVAID System and Develop Traceability using DOORS

• Develop Software Validation Test Cases (SVTC) for testing software requirements

• Prepare Software Validation Plan

• Execute Validation Process

Abbott Laboratories.  Abbott Diagnostics Division   Abbott Park,  IL – Consultant

Participate in division-wide Process Improvement activities including:

• Develop Software Development Policies and Processes to be used across all projects of the division
• Write the Software Requirements Points-to-Consider document providing guidance for the conception of product software
• Write the Risk Management Points-to-Consider document providing guidance on the identification, assessment, monitoring, and mitigation of project risks both technical and managerial

Lead a team of 5 consultants performing an assessment of the Hematology Business Unit’s software development environment and various existing product software architectures to provide guidance and direction for the creation of their next generation products.

Participate in Process Assessment and Improvement of the Requirements Validation effort for the ARCHITECT System.

• Assess ARCHITECT Software Requirements
• Assess Requirements Validation Processes
• Lead Process Improvement effort
• Assess Validation Work Products to ensure Efficient and Effective Test Effort
• Provide Formal Training on Software Development
• Provide Formal Training on various Software Validation Techniques and Methodologies
• Review ARCHITECT Software Test Plans

SORBA Medical Systems, Inc.  Brookfield, WI – 

Development Sub-contractor for the Production of Software for a non-invasive Cardiac Output Assessment Device called STEORRA in preparation for 510K submittal to the Food and Drug Administration (FDA).  Perform Software Development Project and Process Management as well as software development tasks.

Motorola, Inc.  Integrated Electronic Systems Sector   Northbrook,  IL 
Define Software Development Processes and provide technical direction for the Development of the OnStar In-Vehicle System for General Motors.  Responsibilities Include:

• Develop Software Architecture for OnStar System
• Developed High-Level and Detailed Design for the Activation Device Domain for OnStar System
• Define Software Requirements and produce Software Requirement Specification for OnStar System
• Perform Software Requirements Review and Analysis using Operational Software Development Methodology
• Perform Sub-Contract Management Services for development of various packages of software for the OnStar System
• Develop and Provide Software Requirement Definition and Analysis Training and Workshop
• Manage Team of 5 Software Engineers performing Requirements Definition and Analysis
• Manage Team developing Software Packages and System Tests
• Develop System Test Plan, Protocol, and Procedures for Validation of the OnStar System
• Manage Execution of System Test Process
• Develop and Provide UML Software Design Training and Workshops
• Define Complete set of Software Development Processes and Procedures for OnStar Development Team

Aksys Ltd.  Lincolnshire,  IL - Software Engineer 

Participate in the Development of Embedded Real-Time Personal HemoDialysis System running QNX designed using the OMT methodology and implemented in C++.  Responsibilities Include:

• Develop Requirements Review and Analysis Process and provide Training
• Analyze System Requirements
• Develop the Test Apparatus Tool Suite to Automate Test Process across multiple platforms
• Act as Design and C++ Consultant to Development Staff
• Review Object-Oriented Design and C++ Code

Aerial Communications, Inc.  Chicago,  IL - Quality Analyst

Personal Communication Service (PCS) Providers.

• Devise System Test Process and Standard Test Documentation
• Design and Execute Business Process Simulation - Intended to Verify End-To-End Business Process support of the Business Support Control System (BSCS)
• Develop and Execute System Test on PCS Components

Landis & Gyr, Inc.  Chicago,  IL  - Software Engineer

Participate in the Development of Embedded Real-Time HVAC System running pSOS designed using the Booch methodology and implemented in C++ targeted for PCs.  Responsibilities included:

• Devise Object-Oriented Test Methodology and Strategy 
• Develop Object-Oriented Independent Test System including:
• Reverse Engineer existing C++ code using Rational Rose to produce Design Specs using the Booch Object-Oriented methodology
• Participate in Design Reviews and Perform Code Inspection Process

Motorola, Inc.  Chicago,  IL:  Cellular Infrastructure Group  

(Feb. 95 - Sept. 95) Contract Software Engineer.  Participate in the Development of Embedded Cellular Switching System Software written in C and Z80 Assembler using Sun Sparc Stations running Solaris.

• Lead Group of Engineers performing Feature Test
• Lead Engineering Group Performing Port of Software
• Perform Feature Testing on Cellular Switching Systems
• Perform Call Processing Test on Cellular Switching Systems
• Update Design to Reflect Enhancements to Switching Software
• Manage and Execute Error Correction Process including Coding, Fagan Inspection, and Retest of Software
• Code Test Scripts to support Test of Cellular Switch Software

Siemens Medical Systems, Inc.  Chicago,  IL  ( Dec. 93 - Feb. 95) Sr. Principal Software Engineer

Participate in the Development of Nuclear Medicine Image Acquisition and Processing Systems targeted for high-end UNIX workstations written in C, C++, and Interactive Data Language(IDL).  Responsibilities Include:

• Software Development Technical Lead:  Provide Guidance in and Definition of Processes relating to Development Life Cycle
• Develop Integration Plan
• Organize and Manage Consultants
• Perform Requirements Analysis
• Develop Software Design for various portions of product
• Design, Code, and Execute Tests to Validate Software
• Evaluate Software Development tools including GUI Builders, GUI Testers, Structural Coverage Tools, Defect Tracking Systems, Test Management Systems, etc.

Smiths Industries Aerospace & Defense Systems, Inc.  Grand Rapids,  MI

(Feb. 89 - Dec. 93)

• Analyze Customer Requirements to Determine System Software Requirements
• Design Real-Time System Software for Aircraft Navigation and Communication Systems

• Responsible for Analysis of Existing Project Software Design for Incorporation of Enhancements

• Translate Design into Working Code using Ada, C, and Jovial on VAX Micro-Stations
• Design Structural, Functional, and System Tests  to Verify and Validate Real-Time System Software.

• Perform Hardware/Software Integration in a Laboratory Environment