1. Shanna L. Helminen
Mechanical Engineer
13055 Dahlia Circle Apt 204 slhelmin@hotmail.com
Eden Prairie, MN 55344 (763) 772-4328
PROFESSIONAL NEW PROCESS INTRODUCTION DEVELOPMENT ENGINEER II August 2014 – present
EXPERIENCE LAKE REGION MEDICAL Chaska, MN
 Developed new processes for new products introduced to manufacturing
 Designed DOEs for methods attaching platinum to nitinol to determine significant factors
 Developed methods for heat shrinking PTFE and reflowing Pebax and Polyurethane
 Trained NPI department how write protocols and perform IQs, OQs, and PQs
 Assisted in updates to guidance document on statistically valid sampling plans
 Worked directly with customers to develop processes, test methods, and validations
MANUFACTURING PROJECTS ENGINEER II April 2013 – August 2014
ASSOCIATE MANUFACTURING PROJECTS ENGINEER June 2012 – April 2013
LAKE REGION MEDICAL Chaska, MN
 Project manager and technical lead to develop a new process for attaching distal tips
o 23 complaints in 4 years prior to updated process
o 0 complaints in first 1.5 years
 Developed new processes and enhanced design of products to decrease costs and increase
quality for soldering and heat shrinking processes
 Project manager for projects: Developed timelines, formed cost analysis, and directed support
personnel on tasks and deadlines
 Provided production support to maximize process control and solve production issues for
coating, soldering, adhesion, and heat shrinking processes
 Designed DOEs to determine significant process factors and FMEAs to determine risks
 Designed new prototype tooling and fixtures working with the build room and utilizing
Inventor
o Test equipment for testing joint integrity
o Production equipment for automation and handling
 Developed and executed OQs, PQs, and PPQs for new equipment and processes
ASSOCIATE MANUFACTURING PACKAGING ENGINEER March 2011 – June 2012
LAKE REGION MEDICAL Chaska, MN
 Provided production support and solved urgent problems for the Packaging department
 Wrote protocols and reports for IQs, OQs, and PQs, product validations, and product
verifications for various packaging configurations, dispensers, sealers, torque devices,
handles, and other components
 Designed packaging for new products and components
 Provided support and documentation for customer orders
 Modified processes to reduce manufacturing costs
ASSOCIATE RESEARCH AND DEVELOPMENT ENGINEER November 2008 – March 2011
LAKE REGION MEDICAL Chaska, MN
* Used Minitab for statistical analysis of DOEs, Gage R & Rs, Process Capability, and
comparisons of different products and processes to manufacture steerable guidewires,
endoscopic guidewires, and embolic protection devices.
* Wrote protocols, reports, and test procedures for measuring devices and manufacturing
processes

2. * Participated in DFMEAs to ensure design intent and product safety and PFMEAs to evaluate
processes
* Wrote protocols and executed IQs, OQs, and PQs for NPI, Manufacturing, and Design
Assurance Lab equipment
* Developed new processes and trained the training department and production operators for the
processes
* Developed Test Methods for Design Assurance Lab Equipment, wrote test method protocols,
and performed and executed the validation
* Used AutoCAD and Inventor to model products and fixtures
RESEARCH AND DEVELOPMENT TECHNICIAN November 2004 – November 2008
LAKE REGION MEDICAL Chaska, MN
* “Hands on” experience in the medical device industry building guidewires and related
medical devices
* Developed techniques for applications of polyurethane membranes and hydrophilic coating
* Performed tension, compression, lubricity, adhesion, and shear tests using PC controlled test
systems
DESIGN ENGINEER December 2002 - February 2003
SILVAN INDUSTRIES Marinette, WI
* Designed pressure vessels to meet customer specifications and ASME Pressure Vessel Code
* Provided floor support and developed multi-tasking skills by working on several projects
simultaneously
* Solved second shift shop problems including Quality Assurance issues
* Used I-Deas SDRC daily
CONTRACT DRAFTER November 2000 - March 2001
PETTIBONE, LLC Baraga, MI
* Modeled, assembled, and created I-Deas drawings of existing AutoCAD and hand drawings
SKILLS AND Part modeling, assembly, and detailing/drafting with SDRC I-DEAS, Unigraphics, Pro-Engineer, Inventor
SOFTWARE Mechanics of Materials, Mechanism design and FEA with I-DEAS
Word, Excel, FrontPage, Matlab, Simulink, Maple V, FORTRAN
EDUCATION MICHIGAN TECHNOLOGICAL UNIVERSITY Houghton, MI 1998-2002, 2003-2004
Bachelor of Science in Mechanical Engineering, May 11, 2002. Magna Cum Laude.
Passed the Fundamentals of Engineering Exam Overall GPA: 3.69.