JOE BETHKE
Home:    763-420-9956                  http://www.linkedin.com/pub/joebethke               laura_joe_bethke@comcast.net
Cell:    612-554-2839




                                                       SUMMARY

Skilled CAD Designer/Drafter with extensive experience using SolidWorks CAD software to design 3-D models for new
products and for continuous improvement to existing devices. Managed all phases of the product development process
including all aspects of the Design History File and Device Master Record. Heavily involved in writing processes and
creating technical illustrations that greatly enhanced process repeatability and product quality. Background as a machinist
and toolmaker provides in-depth insight to create technical documentation that accurately conveys all information required
to manufacture a product. Careful attention to detail in all aspects of work contributed to the highest Quality of Work
Output rating in performance evaluations.

                                                TECHNICAL EXPERTISE

SolidWorks 2012 CAD Software:       Advanced Assembly, Advanced Parts, Drawings, Sheet Metal, File Management
Product Data Management:            Agile Advantage (Oracle), PDMWorks (SolidWorks)
Microsoft Office:                   Excel (Advanced), Word, PowerPoint, Project (Intermediate)
Enterprise Resource Planning        MISys

                                            PROFESSIONAL EXPERIENCE

OMNI-TRACT SURGICAL (acquired by Integra LifeSciences in 2008), White Bear Township, Minnesota
  Product Development Analyst / Documentation Control Manager, 2006 - 2012
  Created and managed solid models, drawings and technical documentation for new product development and to
  support change requests from other departments.
   Project Manager responsible for the design and development of 6 new medical devices in 2 years, resulting in
      additional domestic and international sales.
   Achieved 90% improvement in cycle time of Engineering Change Orders (from 6 weeks to less than 2 days),
      vastly reduced scrap rate and improved throughput by spearheading a project to achieve full automation.
   Solely responsible for revising engineering drawings, process routers and device labeling artwork for all 448
      saleable devices, required for the successful transfer of operations from Minnesota to Integra in Cincinnati.
   Authored major elements of the Design Control Process and Design History Files in support of new product
      launches, e.g. Validation & Verification Plans, FMEAs and Risk Management Plans, resulting in successful
      regulatory compliance audits.
   Worked closely with Regulatory Affairs and Quality in developing retrospective Device Master Records and
      Design History Files for mature products.
   Responsible for creating new drawings during the product development process as well as updating all old hand-
      drawn prints and AutoCAD drawings to SolidWorks, resulting in homogenous documentation.
   7-years experience setting up product structures from raw material through component, subassembly and final
      assembly levels using Configuration Management methodology via Agile Product Data Management software.

OMNI-TRACT SURGICAL, White Bear Township, Minnesota
  Manufacturing Engineering Supervisor, 1998 - 2006
  Managed a 3-person team which supported the Manufacturing, R&D and Quality departments.
   Led the effort that vastly improved all aspects of the manufacturing processes, including full documentation of
      CNC setups and programs; work instructions for all operations from receiving inspection through final assemblies;
      inspection requirements and methods; and creation of labor costing methodology.
   Successfully addressed a crisis when the supply of a special proprietary stainless steel alloy used in many high-
      volume products was no longer available. Experience in metallurgy, material selection criteria and re-engineering
      efforts led to successful material and configuration changes to many devices, which actually improved their
      performance and reliability.
   Improved throughput of custom order processing from 6 weeks to less than 1 week through effective leadership of
      Lean Manufacturing initiatives including Lean Office, Value Stream Mapping and other Lean techniques.
JOE BETHKE                                                                                                  2 | Page


Manufacturing Engineering Supervisor, Continued

      Key member of the team responsible for attaining ISO 9000 certification in 1996. Developed and wrote most of
       the Quality System Procedures and Work Instructions as well as creating and managing the instrument calibration
       system, and continued involvement in attaining CE Mark certification.

   Production Supervisor, 1988 – 1998
   Managed operations and provided daily supervision of a manufacturing team.
    Led the Manufacturing Department during the initial growth stages of the company. Company sales increased
      from less than $1M per year to over $6M per year during this timeframe.
    Oversaw the development of a 4-person plant with no CNC equipment to a modern manufacturing operation with
      4 CNC machines and 12 shop employees.
    Instrumental in the justification and purchase of several new machine tools including the CNCs.

                                                     EDUCATION

                       2-Year Machinist course - Minneapolis Community and Technical College

                     1-Year Tool & Die Maker course - Faribault Area Vocational Technical Institute

                                   One year at Bemidji State University - Bemidji, MN

                                          PROFESSIONAL DEVELOPMENT

       SolidWorks CAD software, including PDMWorks Vault Administrator - 9 course certificates.
       Lean Practitioner Certification (95% complete) through the Manufacturers Alliance.
       Agile Advantage PLM software Power User certification.
       ISO 9000 Internal Auditor certificate.
       Corrective / Preventive Action and Root Cause Analysis course certificate.
       Geometric Dimensioning & Tolerancing (GD&T) course certificate.
       Certified Manufacturing Technologist certificate through Society of Manufacturing Engineers.
       APQP/FMEA/Control Plans/Mistake Proofing course through Society of Manufacturing Engineers.
       Gage Calibration course certificate.
       Assembly Plant Layout for Lean Manufacturing course certificate.

                                          PROFESSIONAL ASSOCIATIONS

                                           Manufacturers Alliance - Member
                                 Society of Manufacturing Engineers (SME) - Member
                                    American Society for Metals (ASM) - Member

                                               MILITARY EXPERIENCE

U.S. Navy – Completed 4-years with honorable discharge
Positions held include Avionics Technician and Senior Plane Captain of the RA-5C Vigilante.
     Completed a 10-month course in avionics and various military-related and functional training.
     Served (2) 6-month deployments working on the flight decks of aircraft carriers.

Resume 11 27-12 (no address)

  • 1.
    JOE BETHKE Home: 763-420-9956 http://www.linkedin.com/pub/joebethke laura_joe_bethke@comcast.net Cell: 612-554-2839 SUMMARY Skilled CAD Designer/Drafter with extensive experience using SolidWorks CAD software to design 3-D models for new products and for continuous improvement to existing devices. Managed all phases of the product development process including all aspects of the Design History File and Device Master Record. Heavily involved in writing processes and creating technical illustrations that greatly enhanced process repeatability and product quality. Background as a machinist and toolmaker provides in-depth insight to create technical documentation that accurately conveys all information required to manufacture a product. Careful attention to detail in all aspects of work contributed to the highest Quality of Work Output rating in performance evaluations. TECHNICAL EXPERTISE SolidWorks 2012 CAD Software: Advanced Assembly, Advanced Parts, Drawings, Sheet Metal, File Management Product Data Management: Agile Advantage (Oracle), PDMWorks (SolidWorks) Microsoft Office: Excel (Advanced), Word, PowerPoint, Project (Intermediate) Enterprise Resource Planning MISys PROFESSIONAL EXPERIENCE OMNI-TRACT SURGICAL (acquired by Integra LifeSciences in 2008), White Bear Township, Minnesota Product Development Analyst / Documentation Control Manager, 2006 - 2012 Created and managed solid models, drawings and technical documentation for new product development and to support change requests from other departments.  Project Manager responsible for the design and development of 6 new medical devices in 2 years, resulting in additional domestic and international sales.  Achieved 90% improvement in cycle time of Engineering Change Orders (from 6 weeks to less than 2 days), vastly reduced scrap rate and improved throughput by spearheading a project to achieve full automation.  Solely responsible for revising engineering drawings, process routers and device labeling artwork for all 448 saleable devices, required for the successful transfer of operations from Minnesota to Integra in Cincinnati.  Authored major elements of the Design Control Process and Design History Files in support of new product launches, e.g. Validation & Verification Plans, FMEAs and Risk Management Plans, resulting in successful regulatory compliance audits.  Worked closely with Regulatory Affairs and Quality in developing retrospective Device Master Records and Design History Files for mature products.  Responsible for creating new drawings during the product development process as well as updating all old hand- drawn prints and AutoCAD drawings to SolidWorks, resulting in homogenous documentation.  7-years experience setting up product structures from raw material through component, subassembly and final assembly levels using Configuration Management methodology via Agile Product Data Management software. OMNI-TRACT SURGICAL, White Bear Township, Minnesota Manufacturing Engineering Supervisor, 1998 - 2006 Managed a 3-person team which supported the Manufacturing, R&D and Quality departments.  Led the effort that vastly improved all aspects of the manufacturing processes, including full documentation of CNC setups and programs; work instructions for all operations from receiving inspection through final assemblies; inspection requirements and methods; and creation of labor costing methodology.  Successfully addressed a crisis when the supply of a special proprietary stainless steel alloy used in many high- volume products was no longer available. Experience in metallurgy, material selection criteria and re-engineering efforts led to successful material and configuration changes to many devices, which actually improved their performance and reliability.  Improved throughput of custom order processing from 6 weeks to less than 1 week through effective leadership of Lean Manufacturing initiatives including Lean Office, Value Stream Mapping and other Lean techniques.
  • 2.
    JOE BETHKE 2 | Page Manufacturing Engineering Supervisor, Continued  Key member of the team responsible for attaining ISO 9000 certification in 1996. Developed and wrote most of the Quality System Procedures and Work Instructions as well as creating and managing the instrument calibration system, and continued involvement in attaining CE Mark certification. Production Supervisor, 1988 – 1998 Managed operations and provided daily supervision of a manufacturing team.  Led the Manufacturing Department during the initial growth stages of the company. Company sales increased from less than $1M per year to over $6M per year during this timeframe.  Oversaw the development of a 4-person plant with no CNC equipment to a modern manufacturing operation with 4 CNC machines and 12 shop employees.  Instrumental in the justification and purchase of several new machine tools including the CNCs. EDUCATION 2-Year Machinist course - Minneapolis Community and Technical College 1-Year Tool & Die Maker course - Faribault Area Vocational Technical Institute One year at Bemidji State University - Bemidji, MN PROFESSIONAL DEVELOPMENT  SolidWorks CAD software, including PDMWorks Vault Administrator - 9 course certificates.  Lean Practitioner Certification (95% complete) through the Manufacturers Alliance.  Agile Advantage PLM software Power User certification.  ISO 9000 Internal Auditor certificate.  Corrective / Preventive Action and Root Cause Analysis course certificate.  Geometric Dimensioning & Tolerancing (GD&T) course certificate.  Certified Manufacturing Technologist certificate through Society of Manufacturing Engineers.  APQP/FMEA/Control Plans/Mistake Proofing course through Society of Manufacturing Engineers.  Gage Calibration course certificate.  Assembly Plant Layout for Lean Manufacturing course certificate. PROFESSIONAL ASSOCIATIONS Manufacturers Alliance - Member Society of Manufacturing Engineers (SME) - Member American Society for Metals (ASM) - Member MILITARY EXPERIENCE U.S. Navy – Completed 4-years with honorable discharge Positions held include Avionics Technician and Senior Plane Captain of the RA-5C Vigilante.  Completed a 10-month course in avionics and various military-related and functional training.  Served (2) 6-month deployments working on the flight decks of aircraft carriers.