Manager Medical Device
Resume:
Michael Allen North
E-mail:
***********@*****.***
PRODUCTION AND MANUFACTURING MANAGEMENT
QUALIFICATIONS:
> To continue my management career, I am looking to relocate to the
southern part of the United States where I have family.
> Extensive experience building and modifying quality systems to support
work within highly regulated medical device manufacturing environments
> Successful experience building and managing large teams and manufacturing
organizations.
> Creative troubleshooter able to quickly identify and resolve problems at
all levels with an emphasis on root cause analysis and poka-yoke.
> Solid leader able to build, mentor, and develop highly motivated,
productive, and loyal teams.
> Hired, developed and lead 118 direct and indirect team members ranging
from technical engineering to hands-on production.
> Skilled in quality control and highly profitable turnarounds at multiple
locations; manage production line setup, analysis, continuous
improvements, 5S, instituting principals of the Toyota Production System
and Value Stream Mapping.
> Lean Manufacturing, 5S and Project Management certification through
Medtronic Inc., Nintendo of America and Terex/Genie Corporation.
PROFESSIONAL HISTORY:
Physio-Control a division of Medtronic, Redmond, WA
12/2010 - Present
Medical Device Manufacturer, Class III
Production Manager promoted from Sr. Value Stream Supervisor
Proven track record within ISO 13485 and FDA 21 CFR part 820 regulated
environments with an emphasis on lean manufacturing
including proven Kaizen events with net results totaling over 4 million
annually.
> Maintained and developed processes for class III medical devices, direct
responsibility for over 20 regulated guiding
documents.
> Emphasis working collaboratively and cross functionally to achieve
results with net zero budget increase.
> Hands-on leadership style within the Value Stream to align all resources
including purchasing, planning, procurement,
warehousing, production and logistics.
> Reduced overall operating expenses within the department by 3.4 million
through FY '12.
> Currently on pace to reduce overall operating expenses within department
by 1.75 million for FY'13 through lean application
and policy deployment.
Pathway Medical Technologies, Redmond, WA
12/2006 - 12/2010
Start-up Medical Device Manufacturer, Class III
Continuous Improvement Manager promoted from Production Manager
Responsible for continuous improvement projects relating to production
including training and development, 5S training/implementation, data
analysis, increasing quality standards, cost per piece, and assembly line
support.
> Six Sigma Black Belt Certified (CSSBB) with 4 completed
projects resulting in a net savings of $671,323.91
annually
> Led numerous cross-functional teams to drive cost
reductions through outsourcing and internal Kaizen
improvements
> Reduced >1.2 million annually in labor reductions through lean
improvements.
> Authored and deployed policies and procedures to ensure
ISO 13485 and 21 CFR Part 820 compliance
> Led multiple line consolidation projects to reduce the 7
wastes.
> Reduced walking distance by 71%, reduced lead-time from
21 days to 3 through inventory and WIP reductions and
re-allocated 13 headcount which saved $533,000.00 annually.
Terex/Genie Industries, Redmond, WA
09/2005 - 12/2006
Heavy Industrial Equipment Manufacturing
Electrocoating Manufacturing Manager
Responsible for all operations related to electro coating processes
including training and development, adherence to environmental
regulations, 5S training/implementation, capacity forecasting, increasing
quality standards, cost per piece, and assembly line support.
> Led lean initiatives and Kaizen events that increased system
effectiveness with a net increase in assembly operations from 65
units per day to 95 units per day. This increased effectiveness also
avoided the outsourcing of 36+ parts.
> Established a cross-functional team to lead Kaizen improvements through
the Lean Promotions office
> Created multiple Heijunka and Yamazumi boards to level load production
and staff which resulted in increased performance
Nintendo of America, Redmond, WA
04/2005 - 09/2005
Consumer Electronic Manufacturing
Interim Manufacturing Manager promoted from Sr. Production Lead
Introduced and led initiatives relating to Lean Manufacturing, 5S, VSM,
RCA, training and development, Out Plant contractor support relating to
product completion, quality, cost per piece, and inventory accuracy.
Responsible for TQM implementation throughout seven departments with
twenty-eight direct reports including one analyst, one inventory
specialist and three supervisors.
> As the Manufacturing Manager, directed operations wide strategy and
policy deployment policies and participated in a wide
range of duties during Lean Manufacturing implementation including
vision.
> Consistently achieved 99.99% inventory accuracy within all
manufacturing operations.
> Established a successful continuous improvement and training
program from the ground up.
> Authored and deployed procedures for Kaizen events and 5S
implementation.
Nintendo of America, Redmond, WA
09/1999 - 03/2005
Consumer Electronic Manufacturing
Sr. Production Lead promoted from Production Lead.
Effectively managed a first-shift manufacturing operation with a team of
26 hourly workers. Oversaw production processes across seven production
lines to ensure proper adherence to specifications, quality, cost per
piece, overtime and implemented corrective actions as required. Trained
hourly workers in Lean Manufacturing concepts and worked collaboratively
with the team to eliminate waste within production processes.
> Reduced overall production costs for all lines by $560,000 for FY '05
> Met quality goals of 99.45% for FY '02 - FY '05
> Reported on cost savings and provided Metrics data to upper management
Gale Industries, Woodinville, WA
04/1993 - 09/1999
Wholesale Construction Manufacturing
Operations Manager promoted from Production Manager.
Managed a two-shift wood manufacturing shop consisting of 43
direct/indirect staff.
> Increased profit by 12-18% per year by implimenting cost saving lean
measures and by consolidating two production facilities into one over
the span of 1.3 years.
> Implemented a comprehensive cross-training program throughout the
facility that increased morale/flexibility and
decreased attrition.
> Reported to the General Manager/Owner on profitability, production,
quality and budgetary responsibilities.
> Redesigned operations and reduced lead-time by 36%, production by 8%,
reduced manpower by 18% and saved the
$280,000 annually.
> Managed a fleet of 12 delivery trucks and evaluated depreciation to
justify a cost saving lease proposal, which reduced
overall truck operating cost by 22%
[pic]
EDUCATION:
Spokane Community College, 1991 - 1993, Spokane, WA
Associate in Applied Science in Business and Criminal Law
Washington State University, 1993 - 1995, Pullman, WA
2 years, General Studies
Six Sigma Black Belt Certified (CSSBB), 2009, Green River Community
College
Contact this candidate