Manufacturing Engineer, Process Dev., Supplier Quality, Mfg. Quality

Roger Schmidt

Forest Lake, MN 651-***-**** ***********@*****.***

Forward thinking, results oriented, team building Senior Process Development / Manufacturing Engineer highly adept at driving production development efforts to completion for new and existing medical device products

Well-versed in a variety of engineering environments including: device design, modification for manufacturability, and qualification for human use production

CORE QUALIFICATIONS/TECHNICAL SKILLS

Design Engineering Project Management Product Development

Quality Assurance Process Qualification Vendor Component Development

Equipment Qualification Supplier Molding Development Mfg. Continuous Improvement

Lean Manufacturing Six Sigma Training Electro-Mechanical Design

DOE / Statistical Analysis Technical Troubleshooting Root Cause Failure Analysis

Professional Engineering Experience

Consulting / Contract Engineering December 2016 – Present

February 2013 – July 2014

Manufacturing process and equipment review for accuracy, production use, and improvements for leading medical device companies like: Coloplast, Inc., Tendyne Holdings, Inc., Medtronic, and American Medical Systems.

Planned, designed, and supported Tissue heart valve manufacturing and inspected process improvement and documentation. Concept design review, FIM (First In Man) Refined and wrote tissue valve inspection processes for final release of valve from manufacturing.

New Capacitor yield improvements.

Initial quick improvements to revamp capacitor manufacturing yield.

Created long-term capacitor manufacturing yield improvements, Black Belt project.

CAPA Team Remediation to determine process validation compliance gaps for legacy products then created/updated/executed Process Validation Master Plan, TMV’s and gage R&R’s.

Lean Six Sigma Black Belt continuing education – Currently completing certification

Smiths Medical, inc. July 2014 to December 2016

Advanced Manufacturing Engineer – New Product Introduction

Core Team Member for new product transfer to production

Next generation convective warmer / Underbody blanket development

Smart Pump Programming software development – Operations core team member with design transfer to manufacturing focus

Manufacturing support for general design transfer activities

St. Jude Medical, St. Paul, MN March 2008 to September 2012

Senior Process Development / Manufacturing Engineer

Implemented project engineering, new product development support, and transition to production. Provided catheter product development support and transition to high volume manufacturing for human use. Administered tissue heart valve manufacturing transfer to offshore production.

Tissue heart valve and solution prep Mfg. support and transfer to high volume offshore production.

Biological tissue processing solution preparation and transfer to high volume manufacturing.

Porcine leaflet, bovine/porcine pericardium tissue procurement, transport, storage and processing.

Process qualification/validation for product development and transfer to human use production.

Catheter product development and transition to mfg. for human-use, injection mold development.

ev3 (now Covidien / Medtronic), Plymouth, MN April 2004 to February 2008

Process Development Engineer

Design support / supervised production of new products for qualification and human use production. Laser welding manufacturing process development including DOE, GAGE R&R, IQ/OQ/PQ/PPQ and manufacturing engineer support. Conducted manufacturing process statistical capability analysis.

Stent Delivery Systems / PTA Catheter mfg. process characterization including DOE, Gage R&R.

Statistical analysis of manufacturing process outputs to determine process capability.

Software validation leadership / coordination for determination of regulatory compliance.

Process development / qualification / validation build coordination and support.

Manufacturing equipment / fixture design / procurement, improvement and qualification.

Medtronic (Contract) Fridley, MN April 2003 to April 2004

Manufacturing Engineer

Project engineering leadership for catheter transition to manufacturing. Create / qualify inspection and Mfg. Procedures, conducted process improvements. Laser etching equipment development and transfer to high-volume offshore facility. Qualified catheter injection molding and transfer to mfg.

Project management: polymer material replacement, butt-joining technology, mfg. fixtures.

Laser Etch manufacturing technology and fixture development / transfer to Medtronic Puerto Rico.

Characterized/qualified/validated manufacturing processes for diagnostic and Lead Delivery catheters.

Project Leader for Lead Delivery catheter transition to manufacturing; injection mold development.

Catheter insert FMEA, Manufacturing Plan and coordination of Research Feasibility Clinical Lot Build.

Evaluated and integrated packaging materials, equipment and processes for new product release.

St. Jude Medical (Contract) Minnetonka, MN December 2002 to March 2003

Manufacturing Engineer

Create Process control for new product / equipment qualification and transition to Mfg. / Eng. support.

Analyzed/re-engineered new product build processes / components and moved manufacturing to new facility.

Developed and implemented process validation / qualification activities.

Medical Graphics Vadnais Heights, MN June 1997 to December 2001

Manufacturing / Sustaining Engineer

Reinforced and established engineering product improvements, Quality Assurance / Regulatory Affairs support, Manufacturing Support.

Failure Investigations, Root Cause Analysis for Product Performance/Customer Complaints.

Troubleshoot Design / Manufacturing / Supplier issues including MRB activities.

Designed / qualified / released new electromechanical fixtures / components for Purchasing and Mfg.

Wrote Inspection and Manufacturing Procedures and administered ongoing process improvements.

Jacobson Machine Works Golden Valley, MN October 1993 to June 1997

Production Manager Manufacturing / Design Engineer

Supervised Production, Maintenance personnel (approx. 40 people); coordinate mfg. priorities.

Governed Pre-Production manufacturing reviews and advised Design Engineering on mfg. issues.

Education/Certifications / Continuing Development

Bachelor of Science in Mechanical Engineering 1993

University of Minnesota, Minneapolis, MN

CPPM Certified Professional Project Management 2014

University of St. Thomas, St. Paul, MN

Certified CAPA Investigator 2016

Business Excellence Consulting, Inc.

Lean Six Sigma Black Belt 2017

New Horizons Minnesota

Additional Continuing Ed:

Lean Manufacturing DOE/Statistical Analysis

Continuous Improvement Gage R&R

Extracurricular / Volunteer Activities

Board of Director Member, Twin Cities Retrouvaille 2016 – Present

Small Group Leader, Revolution / Ground Zero 2012 – Present

Eaglebrook Church, Lino Lakes, MN

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