JAMES MICHAEL ULWELLING
Eau Claire, WI 54703-2554
**********@*******.***
PROFILE
Mechanical Designer with over 25 years experience in product design. Adheres to FDA GMP quality systems from product requirement specification generation to verification testing. Provides cross-functional support to marketing, manufacturing, and service. Strong knowledge of company products, competitors, and customer needs. Schedule-driven, organized and detail-oriented professional. Experience with the following:
Project Management Product Design, Development, and Testing
Technical Leadership Hands-on Development (Concept to Production)
DFMA High and Low Volume FDA and ISO regulations
Design for Six Sigma Electromechanical Design
Pro Engineer Wildfire 3D Complex Surface and Solid Modeling
Problem Solving /Troubleshooting Technical Documentation
EXPERIENCE
Consultant to 3M, INC. – Maplewood, Minnesota 2006 - present
Diversified Technology Company
Mechanical Designer – Product Development, OH&ESD
Design, development, prototype, validation and scale-up of personal protective equipment (PPE) and systems including powered air-purifying and maintenance-free respirators.
Design and build of inspection/manufacturing fixtures and tools to support commercialization of PPE systems.
EASTMAN KODAK COMPANY – Oakdale, Minnesota 1997 – 2006
Health Group Division –Developer and manufacturer of medical laser imaging products for medical diagnostic applications.
Hardware Engineer – Product Development
Concept development, design, prototype, and test validation of components for medical laser imaging equipment. Perform hands-on development from concept to production, and provide documentation for all developmental phases including design specifications, feasibility, and verification test plans, along with project schedules.
Designed sheetmetal, machined components, and plastic parts. Responsible for design of imager mainframes, panels, mobile and seismic applications.
Commercialized 3 generations of successful medical laser imaging products, including recent scale-up in Asia. Worked closely with manufacturing, supply management, suppliers, fabricators and machinists to develop tooling and components, as well as procure commerical parts. Control of top-level BOM and database assembly of these imaging products.
Led 8150 hardware integration management, working with all groups to reduce cost, number of configurations, and contribute to design transfer of product launch in China.
Met schedule milestones and deadlines under aggressive build cycles.
Adhered to FDA-QSR 21 CFR Part 820, MDD, ISO 9001, and ISO 13485 quality systems.
Designed for UL 60950-1, IEC/EN 60601-1-2 EMC Compliance Standards.
UNITED DEFENSE – Fridley, Minnesota 1996 – 1997
Military defense contractor.
Mechanical Designer– Product Development
Modeled outer shell of MK45 Naval Ship Gun, using Pro/Engineering surface tools.
ECO Documentation.
CRAY RESEARCH, INC. – Chippewa Falls, Wisconsin 1995 – 1996
Manufacturer and developer of supercomputer systems.
Mechanical Designer
Designed and procured parts for a Boundary Scan Test Unit, using Pro/Engineering CAD and Sherpa documentation database.
Layout and design of a fixture used to shape spring connectors for C90 MPP computer.
CASE CORPORATION, INC. – Racine, Wisconsin 1993 – 1995
Manufacturer of Heavy Equipment
Mechanical Designer
Documentaion of excavators, working with the CASE Wausau division on a joint venture with Mitsubishi of Japan.
Layout and design of transmission lines, fuel tanks and cab components with the CASE Racine division, using Pro/Engineering CAD.
Remodeling of parts and assemblies, translating from CATIA to Pro/Engineering CAD database in CASE Fargo division.
SUPERCOMPUTER SYSTEMS, INC. – Eau Claire, Wisconsin 1990 – 1993
Manufacturer and developer of supercomputer systems.
Mechanical Designer
Designed and assembled PCPU substrate test station for SS-1 circuit boards, using CATIA CAD software.
Designed seal/flow test simulating liquid coolant flow SS-1 system
Designed various tools to simplify/improve assembly of computer modules and related parts.
CRAY RESEARCH, INC. – Chippewa Falls, Wisconsin 1988 – 1990
Manufacturer and developer of supercomputer systems.
Mechanical Designer
Designed various panels, covers and trim pieces for Cray 2 8P machine, using ANVIL 5000 CAD software.
Designed storage structures for C-90 PC boards.
CONTRACT DESIGN DRAFTSMAN 1978 – 1988
Minnesota Engineering Company – Edina, Minnesota
JBI, Inc – Osseo, Wisconsin
American Hoist – St Paul, Minnesota
Fox Valley Engineering – Rice Lake, Wisconsin
EDUCATION
UNIVERSITY OF WISCONSIN - STOUT – Menomonie, WI
Certificate, Pro/Engineering Training, 1993
CHIPPEWA VALLEY TECHNICAL COLLEGE – Eau Claire, WI
Electromechanical Technology, 1993
Certificate, Advanced CAD/CAM, 1989
Mechanical Design Technology, 1981-1983
ST PAUL TECHNICAL VOCATIONAL INSTITUTE – St Paul, MN
Statics and Strength of Materials, 1980
PTC ProEngineer – Wildfire, Advanced Part Design, Advanced Sheet Metal, Intralink
GD&T – Geometric Dimensioning & Tolerancing
DFMA – Design for Manufacturing and Assembly, Statistical Tolerance Analysis, System Robustness/Reliability Training
Plastic Part Design – GE Plastics and Diecasting Development Council
Internal System Training includes:
SOP – Standard Operating Procedures
Regulatory Training – Health Imaging Quality System
GMP – Good Manufacturing Practices
PCP – Product Commercialization Process
E-Matrix–(EQDS)