Mike

10/18/2014
Coon Rapids, MN

Position Desired

Manufacturing Engineering
Minneapolis, MN; St. Paul, MN
Yes

Resume

EMPLOYMENT OBJECTIVE
To obtain an engineering position with responsibilities including organizing and managing product manufacturing or development activities.

SUMMARY OF QUALIFICATIONS
• Extensive experience developing thermoplastic injection molded tooling and products. Primary product groups include connectors, headers, implantable components, pacemaker programmers, military/defense, communications, and water filtration products. LSR molding experience has been primarily with spinal surgery devices.
• Injection mold design and tooling development – 19 years
• Project management – 8 years
• Medical Product Manufacturing- 5 years
• Product design and development – 7 years
• CAD-Unigraphics NX-18 years, Solidworks-8 years
• Autodesk MoldFlow Analysis (Advisor Package)-5 years
• Exceptional mechanical aptitude

EMPLOYMENT HISTORY
Sr. Manufacturing Engineer RMS December 2011 to October 2012
• Planned, Developed, and Executed Process and Test Method Validations (IQ, OQ, PQ) for medical device and implantable components in an ISO 13485 medical environment for the medical device industry
• Responsible for tool qualification and DOE studies for molding process optimization utilizing mini-tab software.
• Support sales with quotes for mold tooling, fixturing, and production equipment.
• Performed Moldflow analysis for sales support and injection mold tooling development.
• Developed and documented processes for molding and production assembly using ECO’s, and FMEA’s.
• Evaluated inspection reports and provided input for modifying the molding process or to perform steel changes.
• Identified and supported the execution of improvement efforts to reduce waste in all manufacturing processes through lean methodologies.
• Communicated the project status with customers through phone calls, e-mails, and conference calls.

Sr. Manufacturing Engineer Accellent May 2010 to September 2011
• Planned, Developed, and Executed Process and Test Method Validations (IQ, OQ, PQ) for medical device and implantable components.
• Responsible for procuring mold tooling, production fixtures, and support equipment for assembly and automation.
• Manage projects from conception design for manufacturing through validations and approvals for all design /build, tooling, molding and assembly in an ISO 13485 medical environment for the medical device industry.
• Evaluated inspection reports and provided input for modifying the molding process or to perform steel changes.
• Responsible for tool qualification and DOE studies for molding process optimization utilizing mini-tab software.
• Developed and documented processes for molding, machining, and secondary operations using ECO’s, and FMEA’s.
• Identified and supported the execution of improvement efforts to reduce waste in all manufacturing processes through lean methodologies.
• Communicated the project status with customers through phone calls, e-mails, and conference calls.

Sr. Project Engineer Spectrum Plastics Group January 2007 to May 2010
• Attended meetings with sales and the project team for a formal project kick-off to determine the requirements for production approval, process validation, and production requirements.
• Responsible for procuring mold tooling, production fixtures, support equipment for assembly and automation, and raw materials for production.
• Facilitated regular internal meetings with team members to ensure projects are on track. Communicated the project status with customers through phone calls, e-mails, and conference calls.

Michael Mooney, page 2
• Responsible for the completion of validation activities through production approval. Involved with molding qualification and DOE studies for process optimization utilizing mini-tab software.
• Identified and supported the execution of improvement efforts to reduce waste in all manufacturing processes through lean methodologies.
• Responsible for the approval of the production part with high regulatory medical requirements in an ISO 13485 and defense requirements in an ISO 9001 environment.
• Performed Moldflow analysis for sales support and injection mold tooling development.
• Evaluated inspection reports and provided input for modifying the molding process or to perform steel changes.
• Used IQMS MRP software to set-up the bill of materials and track the cost accounting of projects.
• Developed and documented processes for molding, machining, secondary operations, OSV, and assembly using ECO’s, CAPA’s, and FMEA’s.

Project Engineer E & O Tool & Plastics August 2005 to January 2007
• Attended meetings with sales and the project team for a formal project kick-off to determine the requirements for production approval, process validation, and production requirements.
• Responsible for procuring mold tooling, production fixtures, support equipment for assembly and automation, and raw materials for production.
• Facilitated regular internal meetings with team members to ensure projects are on track. Communicated the project status with customers through phone calls, e-mails, and conference calls.
• Used IQMS ERP software to set-up the bill of materials and track cost accounting.
• Responsible for the completion of validation activities through production approval. Involved with molding qualification and DOE studies for process optimization.
• Responsible for the approval of the production part for the medical and water filtration industry.

Sr. Tooling Engineer Advance Tool December 2003 to August 2005
• Evaluated customer CAD part data and provided design for manufacturing feedback to support sales and customers.
• Facilitated regular internal meetings with team members to ensure projects are on track. Communicated the project status with customers through phone calls, e-mails, and conference calls.
• Responsible for tooling development activities in an ISO 9001.
• Responsible for procuring raw materials, components, production fixtures, support equipment for assembly and automation for production.
• Prepared solid model assembly and detail drawings of the plastic injection mold design using Unigraphics NX software for the medical communications industry.
• Performed Moldflow analysis for sales support and injection mold tooling development.
• Lead Engineer in Unigraphics software development.

Sr. Tooling Engineer Minnesota Mold and Engineering November 2002 to November 2003
• Evaluated customer CAD part data and provided design for manufacturing feedback to support sales and customers.
• Facilitated regular internal meetings with team members to ensure projects are on track. Communicated the project status with customers through phone calls, e-mails, and conference calls.
• Responsible for tooling devel...

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