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Twenty-five years of High Tech and Medical Device Manufacturing, Engineering and Management experience, building High Performing Teams, streamlining business process, and reducing costs while raising quality to record levels. Manage Medical Device development teams under FDA, ISO and IEC standards. Advanced problem solving methodologies utilizing Six Sigma tools to resolve CAPA actions. Lead complex project teams to success, reducing costs while meeting schedule and performance objectives. Certified Six Sigma Black Belt through University of Washington.Multifunctional skills include: Scientific Problem Solving techniques, project management, advanced computer application skills, mechanical, electrical, managerial skills, strategic and tactical drive that achieves success.
Jensen Designs Inc
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Quality Systems Sme ConsultantJensen Designs Inc Sep 2012 - PresentSan Jose, CaSubject Matter Expert for Medical Device Manufacturing specializing ISO 13485 Certificationprocedures and process for Risk Management (ISO 14971), Design Controls (21 CFR 820), CAPA Process (ISO 13485) including Process Validations. • Develop Validation Protocols for key processes• Develop Risk Analysis Worksheet with validated built in automations• Travel as needed to be on site
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Qs SmeThermo Fisher Scientific 2012 - Jun 2013San Jose, CaAssist with updating QSR documents for ISO 13485 certification and final FDA registration to include ISO 14971 Risk Management, Process Validation, CAPA and Deviation Process for compliance. Developed protocols for equipment and process validations and training programs (with quiz) to ensure effectiveness. -
Director Of EngineeringRs Medical Aug 2007 - Jun 2012Vancouver WashingtonA solution provider of muscle stimulator medical devices. Developed and lead a international team of designers to develop the next generation muscle stimulator platform. Obtain 510(k) clearance for US distribution through the FDA and set up production process/fixtures to effeciently process high volume production through the Vancouver facility. -
Director Manufacturing EngineeringPlanar Systems 2005 - 2007
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Manufacturing Engineering ManagerClarity Visual Systems, Wilsonville, Or Jun 2005 - Sep 2006Responsible for the introduction and manufacturing readiness of five new product designs. Introduced DFM, DFT, 5s, scientific method of problem solving and electronic (paperless) data collection and tracking systems (CATS). Lead a cross functional and inter-company team to success with the redesign effort of the iS60 plasma intetrated display sign. Lead the Problem Investigation Team to resolve quality issues and inner department process optimization.
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Manufacturing Engineering AnalystMaxtek, Beaverton, Or Jun 2004 - Jun 2005Developed a data conversion system that transferred over eighteen thousand Bill Of Material and Routing records from QAD to the new Oracle Work In Process data system. Created printing solutions, bar code tracking systems, and designed the 2d serial number used for tracking manufacturing and test history for each assembly. Developed Quality data Collection Plans and implemented “pedigree” build history customer facing reports. Wrote detailed reports based on analysis of data pulled from Oracle through complex hand written SQL routines.
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Operations Engineering ManagerCredence Systems, Hillsboro, Or Jun 2000 - Jun 2004Developed and executed a test strategy to significantly reduce the cost of manufacturing large semiconductor test systems. Lead a team of eighteen Manufacturing and Test Engineers toward Design for Test and Design for Manufacturability methodologies that melded the requirements of outside Contract Manufacturer with the design. Success was achieved in reducing the required technician headcount 75% while first pass board test yields rose to record levels. Used Process Model simulation software to re-engineer the total manufacturing process to reduce cycle times from 40 days to 8 days. Lead a cross divisional team that developed a Build To Forecast manufacturing model and received multiple awards for successful implementation of innovative solutions. Developed “Assuring Quality” a networked Quality data tracking system containing root cause and prevention action tracking that improved product quality and reduced rework costs by 40%.
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Operations Engineering MgrCredence Systems 2000 - 2004Managed a team of Test Engineers, Mfg Engineers and Electronic Technicians to drive costs down, reduce process time from 40 days to 7 while increasing quality and reliability of the test systems produced.
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Engineering Manager, FireflirFlir Systems Inc, Portland, Or Jun 1997 - Jun 2000Lead design Engineering Team to success of developing the FIREFLIR infrared camera from concept into manufacturing. Developed templates for Manufacturing Plans, Service Plans, and Quality Plans and initiated Pilot builds. The project was deemed "The most successful New Product Introduction in the company’s history". Worked with Circuit Board, metals, plastics vendors to set up demand flow technology utilizing techniques such as Flying Probe Test, precontrol, and other quality tools. Key contributor in development and implementation of the company’s New Product Introduction process. Also lead a team of Manufacturing Engineers to resolve day to day floor problems and prepare new products for NPI -
Engineering Project ManagerFlir Systems, Inc 1997 - 2000Lead a team of Engineers from all disciplines to develop the FireFLIR helmet mounted infrared imager for firemen and search & rescue operators.
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Sr. Manufacturing EngineerInfocus Systems, Wilsonville, Or Jun 1996 - Jun 1997Responsible for the manufacturing process of assembly and test of projection systems. Worked with outside Circuit Board Assembly suppliers to improve yields and implement cost reductions. Created a Unit Quality Tracking, Field Failure analysis Database and Quality Assurance Database (in Microsoft Access) for improved product quality, production process yields failure analysis. Increased first pass yields from 20% to over 90%. Introduced and standardized bar code format for unit and lot date tracking. Programmed Automation Controller for various "smart" fixtures. Lead a team of Manufacturing Engineers to focus on specific projects
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Automation Engineering ManagerPrecision Interconnect, Portland Or Jun 1993 - Jun 1996Managed a department of technically diverse mechanical, software, and electrical engineers responsible for design, assembly, and test of micro-miniature cable processing equipment and systems. Researched and provided new innovative solutions to bottleneck situations in all areas of production. Improved quality, reduced scrap, and increased throughput in all lines. Programmed PLC and PC Automation Controllers for several projects. Invented IR position sensor feedback system for fine wire payoff module. Achievements include:* Reduced manufacturing costs more than 10% through process improvements and scrap reduction * Project manager for seven large multi resourced projects totaling over $2,000,000. * Led (drove!) multifunctional team that developed a motorized server machine that quadrupled throughput in the server area capturing market share and profitability leadership for several years.
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Production Unit LeaderPrecision Interconnect, Portland Or Jun 1990 - Jun 1993Managed a business unit of 75 people consisting of engineering, production, and quality control engineering. Responsible for leading product development, manufacturing engineering, production coordination, and customer support for medical video arthroscopy camera cables, oscilloscope probes, and high speed timing probes used in the test and measurement markets. Introduced Self Directed Work Teams into the company with two teams achieving High Performing status.
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Production Unit ManagerPrecision Interconnect 1990 - 1996Build High Performing Work Teams that built ultrasound imaging cables using micro-miniature coax cables bundled and terminated at each end (hand soldered). Lead both business units for Custom Medical and Test and Measurement manufacturing systems.
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Senior Manufacturing/Reliability EngineerE-Machines, Inc, Beaverton, Or Jun 1988 - Jun 1990Responsible for new product evaluation and manufacturing process development for new technology video control circuit boards and color monitors. Worked with outside manufacturing resources in Taiwan and Australia coordinating Design for Manufacturability improvements from engineering into production.
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Manufacturing Engineer IiMetheus Inc, Hillsboro, Or Jun 1987 - Jun 1988Developed solder flow operation for large back plane circuit boards and multiple lay up video controller printed circuit boards. Leader for the company's first double sided surface mount board project.
Earl Aune Skills
Earl Aune Education Details
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Business Management -
Mechanical And Industrial Engineering -
Devry Institute Of TechnologyElectrical Engineering
Frequently Asked Questions about Earl Aune
What company does Earl Aune work for?
Earl Aune works for Jensen Designs Inc
What is Earl Aune's role at the current company?
Earl Aune's current role is SME Consultant at Jensen Designs.
What is Earl Aune's email address?
Earl Aune's email address is ea****@****cal.com
What is Earl Aune's direct phone number?
Earl Aune's direct phone number is +150334*****
What schools did Earl Aune attend?
Earl Aune attended University Of Washington, University Of Phoenix, Portland Community College, Devry Institute Of Technology.
What are some of Earl Aune's interests?
Earl Aune has interest in Camping, Fishing, Shooting And Cycling.
What skills is Earl Aune known for?
Earl Aune has skills like Project Management, Managerial Skills, Leadership, Quality Control, Engineering Management, Manufacturing Engineering, Cross Functional Team Leadership, Iso 13485, Product Development, Design Of Experiments, Manufacturing, Lean Manufacturing.
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