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Senior Mfg Engineer

Location:
Monroe, NC
Posted:
July 07, 2015

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Resume:

Michael Locke **** Olive Branch Rd. Monroe NC, ***10 503-***-****

http://www.linkedin.com/pub/michael-locke/39/840/778 acqmrf@r.postjobfree.com

twitter.com/michaelelocke

Qualification Summary

Highly skilled manufacturing engineer with years of experience improving quality, profitability and processes within the medical device manufacturing industry. Demonstrated ability to develop new and maintain existing processes for manual and automated operations. Detail oriented, self sufficient and action oriented, I am a motivated, influential individual who works well with and mentors others. Certified Lean Six Sigma Black Belt and engineering leader of continuous improvement events (Kaizen) that produced significant results.

Professional Experience

Welch Allyn Monitoring/Defibrillators, Beaverton Oregon Feb. 1990 to Jan. 2015

Senior Manufacturing Engineer

Responsibilities:

Driven process improvements through problem-solving, documented training of production personnel, and periodic review of all medical monitor operations from stocking of parts to packaging.

Lead implementation and validation of new product development processes, support and improvement of class 2 and class 3 medical device manufacturing.

Active leadership in production lean projects through Kaizens, daily Gemba team activities, and bubble up suggestions from assemblers.

Development of mechanical and electrical fixtures, equipment, and automated test equipment (ATE) required for production line.

New medical monitor product release to manufacturing (VSM III, Propaq LT, AED 10).

West coasts Mfg. Engineering lead for new product release of Welch Allyn’s flagship monitor CVSM 6000.

Lead Manufacturing operations transfer of division moves for the following manufacturing lines; Defibrillator line from Chicago to Beaverton 2006, CO2 Sensor production from Wisconsin 1998, building consolidation 2001, Thick films surface mount IR source production line from Seattle, 2000. Assisted with monitor line moves from Beaverton to Syracuse NY 2014

Developed “Make or Buy” strategies for sub assemblies, batteries and wire/cable harnesses.

Worked with vendors to develop new or transfer existing assemblies. Cables and Wire Harnesses, PCBAs, Complex panel assemblies, and various accessory assemblies.

Accessory development and process implementation for monitors and defibrillator products.

Have designed and implemented packaging (commercial and Military) for almost all shipping cartons used at welch Allyn Beaverton.

Designed and released to production VRLA Battery assemblies. Developed process controls of assemblies for VRLA, NiMH, and Lithium Ion rechargeable Batteries.

Authored and implemented verification and validation Strategies and protocol/reports for existing, transferred, and new processes to FDA requirements, 21CFR Part 820 and compliance testing to IEC-60601. I was the resident validation subject matter expert and authored the company’s verification trial procedure.

Quantum Medical Systems, Issaquah, WA Sept. 1986 to Jan. 1990

Systems Technician.

Responsibilities:

Final test and acceptance of color blood flow ultrasound machines.

Analog and Digital PCB test and troubleshooting.

Service support.

Michael Locke Woodworking Mar 2000 to Jan 2006

Owner operator.

Responsibilities:

Design and build replacement panels for Stryker Infant warmer cabinets for sale to local hospitals.

Certifications

Certified Lean Six Sigma Black Belt, Oregon Bioscience Association.

IPC/WHMA-A-620 Wire/Harness Assy Requirements.

IPC-A-610, Acceptability of Electronic Assemblies.

Software

Competent with most Microsoft Office products including Microsoft Project and Visio.

Fluent with business operations software SAP and Agile.

Personal Activities

Enjoy fishing, playing guitar and golfing. Accomplished Woodworker.

Education

ITT Technical Institute, Portland Oregon

Bachelors, Automated Manufacturing Technology, 1986

Associates, Electronics Engineering Technologies, 1984



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