Six Sigma Engineer

Michael A. Lackner *** Arrowhead Lane

Sagamore Hills, Ohio 44067

440-***-**** Mobile

*************@*****.***

Profile

Accomplished professional with impressive 15-year career in manufacturing

engineering, technology/design engineering, process engineering, lean

manufacturing, and quality engineering. Expertise in project management,

cross-functional team leadership, kaizen events and small business

management. Recipient of the 2009 Veeder Root President's Award for

exceptional, consistent top performance. Certified GE Six Sigma Green Belt,

Technology Six Sigma Black Belt and GE Product Cost Take-Out Engineer.

TOOLS AND PROCESSES:

< Problem solving tools - Six Sigma, 5-why, 8D, Cause and Effect

(Fishbone), Causal Maps (tree diagrams), FMEA.

< Production Part Approval Process (PPAP) - Six Sigma, minitab, process

capability analysis, flow charts, control plans, process failure mode

effects analysis, submission warrants, supplier assessment, Gage R&R.

< Six Sigma technical review process - Quality Function Deployment,

FMEA, Statistical Process Control, Measurement System Analysis, First-

Piece Approval Process, Process Flow Maps, DOE, Quality Control Plans,

Restriction of Hazardous Substances reviews, Safety reviews, Risk

Management, and Environmental Health and Safety Reviews.

< Corrective actions for non-conforming materials - NCR, 8D, root cause

analysis, 5-Whys, containment.

< Kaizen Process improvement - Value Stream Mapping, 5S, Kanban, TPM,

VRK, SW, PQPR, 3P, 7-way, Poke-Yoke, Job Element Sheets, Pugh Matrix,

OEE, TPI, and Fishbone Diagram.

< Reliability Engineering/Failure Testing, New Product Introduction,

Environmental Health and Safety Training, Reconcile Investment and

Expense, Materials Tracking, Technical Testing, Business Team

Meetings, Just-in-Time Production, Action Work Outs.

Career Experience

Ben Venue Laboratories (Boehringer-Ingelheim Pharmaceuticals), Bedford,

Ohio, 04/25/2011 - Present

Process Specialist III - Lean Six Sigma Black Belt - Business Process

Excellence Team

Lead and coach cross-functional teams at all levels of the organization to

resolve performance, quality, and compliance issues while implementing

process improvements using lean and six sigma methodologies. Train site

personnel and facilitating workshops reacted to lean tools/methodologies,

problem-solving techniques., problem-solving, risk assessment, process

continuous improvement, and gap analysis. Lead activities to correct and

improve internal process issues that are assigned CAPA (Corrective Action

Preventative Action) reports in a cGMP environment (per FDA CFR 21

guidelines).

< Focus Factory continuous improvement: Created and implemented

visual management and metric (KPI) boards (PRESSS) for supply chain

management performance improving Batch on-time-delivery by 50% in

Phase IV focus factory while reducing deviations from 2.3 per day

to 0.7. Implement idea catcher program with over 30 ideas per

month dispositioned. Created and implemented departmental

performance center boards. Kaizen funnel to track all CI

activities.

< Led Area Ownership Program (AOP) team: Led to lean conversion and

5S+1 implementation in four focus factories (over 60 areas) with

layered-auditing process and assigned owners enabling culture

change to one of horizontal accountability and sustainability of

area readiness..

< BVL Lean Six Sigma Pharma Greenbelt Training and Boehringer-

Ingelheim Global Six Sigma team member: Author and teach modules

and mentor Greenbelts.

< Strategic Metric Development: Partnered with Focus Factory,

Engineering, Maintenance, and Business Process Excellence senior

leadership to develop strategic metrics (Policy Deployment).

< Leader of Critical Response Process Improvement Team: Led nine sub-

teams resolving Maintenance process and system issues discovered

during agency audits (FDA and EMA) which led to site voluntary shut-

down. Led closure of 2,331 non-complaint work orders and 32%

improvement in on-time completion of preventive maintenance work

orders.

< Workshop facilitator: Facilitated many risk analysis (per ICHQ9),

problem solving, metric creation, and process improvement

workshops.

< Coach Indirect Materials Process Improvement team: Creating new

processes for procuring, scheduling, and tracking indirect product

contact disposable (PCD) inventory items including implementation

of kanban eliminating rescheduled batches due to PCD stock-outs and

proper traceability.

Philips Healthcare Imaging Systems, Highland Heights, Ohio, 09/27/2010 -

04/24/2011

Supplier Quality Engineer

Manage cross-functional teams to implement corrective actions and

preventative actions for non-conforming supplier material. Owner of 28

international suppliers. Use problem solving techniques and continuous

improvement tools to develop weak suppliers. Lead activities at Philips

Healthcare to correct internal process issues that are assigned CAPA

reports. Collect and interpret data for all Philips Computed Tomography

and Nuclear Medicine Inspection Systems defect reports. Lead IS Operations

monthly Quality meetings reporting data to senior management.

< Team Lead, FDA 483 CAPA: resolve process non-conformances for

inventory.

< Team Lead, FDA 483 CAPA: resolve processes for handling and

installing ESD devices sensitive devices.

< Member of Philips Continuous Improvement Team: Initiate continuous

improvement activities. Implement quick kaizens in factory.

< Lead Quality Operations (QOPS) monthly meetings for reporting all data

for internal and supplier defect reports, customer complaints,

defective material, supplier corrective action reports (SCAR),

manufacturing quality, and Quality and Regulatory activities.

< Manage 28 international suppliers. Manage supplier non-conforming

materials using 8D and SCAR process. Daily gGemba walks in factory to

speak to operators concerning any current issues on the floor.

Veeder-Root (Danaher Corporation), Altoona, PA, 10/2008 - 09/2010

Supplier Quality Engineer, 03/2009 - 09/2010

Manage project teams and buyers to qualify new suppliers and parts for

world class lean manufacturing facility with $250 million annual sales.

Take corrective action for non-conforming supplier material. Use problem

solving techniques and continuous improvement tools to develop weak

suppliers. Lead kaizen events at supplier locations to improve supplier

quality. Manage fast-track projects and "close-the-gap" initiatives to

product capital. (Downsizing caused change to this position from the DBS

Manager position below.)

< Created Veeder-Root Altoona Supplier Development Program

< Improved supplier defect rate from 3600 to 1189 PPM duringPPM during

2009 saving hundreds of thousands of dollars and improving market

place reputation.

Danaher Business System (DBS) Manager/Continuous Improvement Manager,

10/2008 - 03/2009

As member of Vice President's staff, worked with Director of DBS managing

lean manufacturing projects and policy development activities to achieve

corporate metrics for safety, quality, delivery, inventory, and

productivity. Coordinated kaizen activity. Developed and tracked level one

and two policy deployment breakthrough policies, improvement priorities,

and targets using Key Process Indicator (KPI) metrics. Created and deployed

Action Plans to support policy deployment objectives. Created and

implemented short and long-term countermeasures for missed KPIs. Trained

associates in lean manufacturing tools and led focus groups in the

utilization of problem solving tools.

< Resolved largest negative impact on the On-Time Delivery metric by

leading kaizen team and utilizing Variation Reduction and Total

Productive Maintenance tools.

< Led three Manufacturing Engineering projects qualifying wireless

products for production.

< Served as Interim Safety Manager (due to downsizing) managing all

safety activities and training.

< Developed and implemented plant Safety Hazard Assessment tool modeled

after Failure Modes and Effects Analysis (FMEA).

Technology Six Sigma Black Belt, Roper Corporation (GE Consumer &

Industrial), LaFayette, GA, 09/2004 - 10/2008

Managed domestic and international cross-functional teams to implement

capital Design, Quality, and Product Cost Take Out projects meeting company

metrics and satisfying customer critical to quality requirements.

Coordinated with New Product Introduction teams to implement projects in

blocks. Presented projects to business management for approval and managed

capital funding and timelines. Designed product and verified development,

supplier processes and quality. Worked with buyers, materials groups,

marketing, customer service, technology management, and manufacturing

groups to launch product on time and assess project for future improvement

opportunity. Qualified new suppliers in technical and quality capabilities.

Certified GE Six Sigma Greenbelt (DMAIC and DFSS).

< Saved $7+ million in yield since 2005.

< Participated in Shingijutsu (KAIZEN) events to remove process waste

and continuously improve processes.

< Mentored other engineers in Product Cost Take Out Methodologies and

Six Sigma.

< Certified GE Product Cost Take Out Engineer.

< Assured materials conformed to European Union restriction of hazardous

substances (RoHS) specifications.

< Assured designs exceeded UL and CSA agency specifications.

< Led Idea Generation Team (Tiger Team) in 2005 / Organized and led

community service events with Co-Ops.

< Served as Cooperative Education Coordinator from 10/2005 to 12/2007

recruiting, interviewing, and hiring 20 Technology Engineering Co-Ops

each semester--made team assignments and mentored Co-Ops in GE

culture.

Process Engineer, Saint-Gobain Performance Plastics, Mantua, OH, 01/2000 -

09/2004

Lead cross-functional teams in implementation of capital projects

eliminating waste and reducing costs. Quoted new assemblies for product

management team, entered BOMS, and specified equipment. Led three Kaizen

events, performed quality functions, and implemented safety and ergonomics

projects. Rearranged hose assembly area for better flow reducing 88 percent

of aisle crossing, 16 percent in storage, tow motor waiting time one hour

daily gaining 320 man hours annually. Generated cost savings of $279,000

annual and $34,000 annual for Graco Assembly project and Spring Pull

Automation projects respectively.

Engineer, Recycling Specialist, International, Cleveland, OH, 08/1998 -

01/2000

Performed engineering duties including design, process, technical support,

engineering sales, project management, and quality for small manufacturer

of TYPHOON commercial air conditioning units (Division of Anderson-Bolds)

with $5 million annual sales. Wrote company quality manual. Supervised

production and managed projects. Reorganized facility for more efficient

material flow, component locating, safety, and quality.

Manager/Assistant Manager, Results/Body Masters/Worlds Gym, Mentor, OH,

01/1992 - 01/2001

Aviation Structural Mechanic Petty Officer Third Class, United States Navy,

Virginia Beach, VA, 12/1987 - 12/1991

Education / Training

Danaher Business Systems School, Chicago, IL - 02/2009

Bachelor of Science in Industrial and Manufacturing Engineering, Cleveland

State University, Magna cum Laude (Worked way through college - 45 hours

per week of work plus full-time college. Also worked out 1.5 hours per day

and participated in national sport competition.)

COMPUTER SKILLS - Microsoft Word, Excel, PowerPoint, Access, Publisher,

Project, Outlook; Lotus Notes, Lotus WordPro; LAN/WAN; Microsoft Windows -

DOS, UNIX; Internet

Contact this candidate