LARRY R. SCHMIDT
**** ********** ***** ( Indianapolis, IN 46254
E-mail: ************@*****.***
Objective: to obtain a challenging Process Engineering position.
HIGHLIGHTS OF QUALIFICATIONS
( Understanding and applications of the Quality Management System for
Medical Devices: ISO 13485.
( Six years of Medical Device experience
( Applications of Statistical Analysis for Process Controls, Design
Controls, Test Validations and Acceptance Sampling.
( Direct involvement in numerous audits by FDAand TUV
( Proficient in the use of statistical software including Minitab,
Design Expert, SPSS and StatGraphics
( Excellent project management and planning skills
( Ability to apply advanced statistical methods to improve process
capability, reduce process variation and optimize
performance
EMPLOYMENT / RELEVANT EXPERIENCE
Boston Scientific (Medical Device Industry supporting
Endosurgery) (2003 to present)
Engineering Essentials Manager; Six Sigma Manager; Sr. Six Sigma
Engineer
Lead multiple Process Validation activities including
Installation Qualification, Operational Qualification, Product
Performance Qualification, and Test Method Validation for
Endoscopy, Urology and Oncology medical devices.
Expertise in Risk Analysis Documents (DFMEA, PFMEA) analysis
and application to complaints to improve the quality of products
produced.
Conducted over 350 hours of Green and Black Belt training
Trained engineering staff on Process Validation including
Overview Training, Sampling Plans, and
Co-developed internal certification system for Green, Black and
Master Black Belts
Lead Kaizen Events and DMAIC projects to support site
Lead validation team to complete Secondary Attribute Test
Method Validations
Supported corporate software validation team for the validation
of Minitab statistical software
Lead CAPA project work for FDA Audit Readiness
Conseco Services LLC (40/86 Advisors)
(2001 to 2003)
Lean Six Sigma Black Belt
Completed six Lean Six Sigma Projects for a total financial
impact of $7.9 million
Managed projects to improve Fixed Income Research process
Designed and implemented Mortgage Dollar Roll process utilizing
Design for Six Sigma
Completed Black Belt Certification
Trained associates in Six Sigma, Process Management, and
Sampling Theory
Praxair Surface Technologies (Eyeglass Lense Industry)
(1995 to 2001)
Quality Manager; Manufacturing Engineer
Completed 10 Lean Six Sigma projects with a total financial
impact of $1.9 million
Maintained ISO 9002 Registration and conducted first, second
and third party audits
Completed Green Belt Certification including three Designs of
Experiment
Managed Quality Assurance Department and 3 associates
(Sustaining Engineer, Document Controller, and Quality
Technician)
United States Gypsum Company - East Chicago, Indiana
(1993 to 1995)
General Foreman; Process Engineer
Managed production department with 25 operators and mechanics
Managed capital projects to modernize and automate material
processing operations
Managed environmental engineering program for manufacturing
facility
Implemented preventive maintenance program
EDUCATION
Butler University; Indianapolis, Indiana
Master of Business Administration
Purdue University; West Lafayette, Indiana
Bachelor of Science Mechanical Engineering
Continuing Education:
Six Sigma Black Belt Training offered by Air Academy Associates for
Praxair Surface Technologies, Inc.
Process Excellence (Six Sigma) Training offered by Oriel Inc. for
Conseco Inc.
Five weeks of Master Black Belt and Black Belt training covering
Train-the-Trainer, DMADV/ Design for Six Sigma (DFSS), DMAIC,
and Process Management