Engineer Medical Device

Rory G. Schmidt

***** ***** ***

Eden Valley, MN 55329

320-***-**** Home

320-***-**** Cell

*******.****@*****.***

Objective

To make a significant contribution to a company by leveraging my technical, quality,

sales and management experience.

Work History

Product Development / Applications / Quality Engineer Ametek / Technical Services for

Electronics (TSE), Arlington, MN (2/10 – Present) Ametek/TSE is the leading supplier of

Medical Device Interconnects.

• Managed the design and manufacture of medical interconnect solutions for leading

medical device manufacturers.

• After 6 months of employment took over the technical interface and design

responsibility of TSE’s major account. This account reflects 66% of TSE’s revenue.

• Led the Upgrade to the NPI process to align and function more efficiently with

ISO13485, ISO 9001, and FDA expectations and requirements.

• Led TSE’s Taiwan and Shanghai manufacturing sites locations in the development of

the first products built in Asia for a major USA medical device manufacturer.

• Lead the technical sales effort from initial project discovery through manufacturing at

high volume.

• Develop and manage the cost of unique product solutions from quoting through

production.

• Introduced statistical methodologies into the IQ, OQ, and PQ processes.

Director of New Product Development Tolomatic, Hamel, MN (7/07 – 10/09)

Tolomatic is manufacturer of electro-mechanical linear motion products.

• Using ISO 9001 established a cross functional new product development process that

reduced the product development cycle by one half.

• Developed and provided strategic direction for the New Product Development efforts

by interacting and developing relationships with CEO’s in the automation industry.

• Established expectations of products, services, and system level requirements from

Voice of the Customer interviews, industry trends, and customer feedback.

• Investigated and conducted due diligence for acquisition opportunities.

• Utilized FMEA’s, DOE’s, FEA, and Six Sigma Statistical Methods to develop new

products that met varying customer requirements.

• Managed the regulatory compliance of the existing electromechanical products and

provided strategic compliance direction for products in development.

• Responsible for the management of the R&D budget.

• Developed and equipped the product testing laboratory with the mechanical means

and the statistical tools that enabled statistical protocols to define the product

reliability.

Program Manager Hutchinson Technology Inc., Hutchinson, MN (11/05 – 06/07)

Senior Product Design Engineer / Supervisor (9/98-11/05)

Project Engineer Equipment R&D and Tool Design, (5/97- 9/98)

Hutchinson Technology Inc. is a leading supplier of precision mechanical and electrical

hard disk drive suspension assemblies and medical devices.

• Lead cross functional teams of quality, sales, marketing, development, components,

and focus factory to execute customer and financial goals.

• Provided Technical and Operational Strategic Planning for the customer specific

Strategic Business Unit by managing the technical and product strategy for the

customer specific strategic business unit.

• Managed the operations indicators and quality performance for each product once

they transferred to the volume focus factory site.

• Established and maintained the customer specific capital forecast and budget

• Used Cp, Cpk, and other statistical methods as feedback to improve GD&T

tolerancing of manufactured components and assemblies.

• Processed designs using FMEA’s, DOE’s, and Taguchi techniques to design out

impending problems.

• Staffed and mentored entry and multilevel engineers on developmental opportunities

for their personal and professional growth.

• Provided strategic feedback to the marketing team and the advance development team

on industry direction.

Design Engineer / Team Leader / Applications Engineer, Komo Machine, Inc., Sauk

Rapids, MN (3/92-5/97)

Komo Machine is a manufacturer of automated manufacturing and assembly systems and

company specific CNC machine tools.

Education

Bachelor of Science in Mechanical Engineering

University of Minnesota. Graduated December 1991. GPA 3.03

Management Study

Harvard Series of Executive Management, Harvard, MA.

St Thomas Academy Extension Courses, St Paul MN

Belleville Area College, Belleville, Ill GPA 3.64

Computer Software

I am proficient at the following software: Ansys FEA, Pro Engineer, Mechanica,

Solidworks, Algor FEA, AutoCAD, Design Ease DOE, Windows Suite and Lotus Suite.

Patent Award

Patent No. US 6,967,819 B1 Head Suspension with Chip as Structural Element.

Personal

Affiliations

Member of the Air Force Reserve with a current DoD Secret Clearance

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