Director of Manufacturing
Coon Rapids, MN – 55433 – 612.619.3066 – firstname.lastname@example.org
Project Management – Quality Operations – Medical Device
Product Development & Launch Successful track record of meeting and exceeding quality and regulation standards by
Design Testing & Analysis resolving complex project challenges with long-term and permanent solutions.
Performance Specifications Strong knowledge and history of implementation of engineering statistical tools and
Team Leadership & Training methodologies such as Excel, Minitab, Design of Experiments (DOE), hypothesis
testing, capability analysis, measurement systems analysis, FMEA, DMAIC problem
Quality Assurance solving, and additional Six Sigma Methods.
Analytical, resourceful professional with extensive experience with lab environments
Process Re-design and medical equipment, to include microscopes, oscilloscopes, viscometers, gloss
Cross-Functional Leadership meters, gas chromatographs, and mass spectrometers.
Supplier and Client Relationships Professional experience in chemical development. I.E. adhesives, pigments, UV inks,
Research & Development rheology modifiers and thermosetting polymers.
Multiple U.S. Patent Holder Collaborative communicator skilled in building top-performing teams and
strengthening relationships across departments and stakeholders to achieve project
Development and execution of IQ,
goals and operational success.
OQ, and TMV protocols
• Awarded five United States Patents for unique technologies and software.
• Revitalized project management processes to ensure all activities meet quality control and design specifications.
• Integrated Lean and Six Sigma methodologies into processes.
• Created procedures and test methods of products to meet quality and regulation requirements while conducting root
• Managed cross-functional teams to bring products and projects from concept to implementation.
EXPRESS IMAGE • Little Canada, MN July 2018 to Current
Director of Manufacturing
Principal strategist of the manufacturing processes of screen and digitally printed OEM and retail products. I oversee
quality output, development and implementation of corrective actions, monitoring and improvement of labor performance,
and the trending and management of quality issues used in continual improvement efforts.
• Leadership: I direct a team of six managers and sixty operators on all issues involved in manufacturing, quality, and
productivity in addition to serving on the company’s leadership board.
• Supplier and Client Relationships: Engage suppliers and clients through proactive communications regarding quality
issues, project planning and status; ensuring that the company delivers elite customer service through collaborative
interfacing and comprehensive follow up.
• Project Management: Implement successful strategies for project completion by managing policy development and
deployment in areas of lean manufacturing, quality, cost reduction, complete and on-time delivery, safety, employee
relations, and performance metrics.
Page 2 • Career Progression (Cont.)
MEDTRONIC •Minneapolis, MN Feb 2011 to July 2018
Principal Analysis Technician
I Performed electrical, mechanical, chemical, material, and firmware analysis on explanted medical devices. Focusing on
root cause failure of implantable infusion systems and creating specific and accurate documentation of the analysis
results. Tasks include extensive CAPA involvement with R&D and reliability, theorizing and testing improvements for future
generations of medical devices, developing new test methods, development and execution of IQ, OQ, and TMV protocols,
authoring and approving work instructions, leaning processes, training technicians, and designing along with maintaining
proprietary analysis equipment.
• Operations Leadership: Directed a team of eight technicians through design theories, root cause analysis, and
testing enhancements for post market quality issues related to implantable infusion systems that aligned with FDA
regulations and resulted in design improvements.
• Process Improvement: Significantly reduced analysis work in progress backlog from 900 complaints to fewer than
150 through the restructuring key procedures, thus meeting FDA regulation requirements.
• Efficiency & Quality Improvements: Decreased annual department labor costs by $175K by developing and
implementing leaning processes, improved technician training, allowing for not only a cost savings, but also freeing
up resources to focus on critical device failure complaints.
MICHAEL FOODS (NORTHERN STAR CO.) • Chaska, MN Feb 2010 to Feb 2011
M5 Maintenance Technician
Configured and maintained electronic and mechanical production equipment, including the upgrade, modification,
programming, and problem diagnosis for processing and packaging.
STEALTH MARK (TRACKING TECHNOLOGIES) • Minneapolis, MN Dec 2001 to Oct 2009
Held responsibility for all aspects of R&D, Manufacturing, and the Quality Control of new products. Authored standard
operating procedures and testing methodologies adopted companywide. Tracked quality and integrity of products though
the development and implementation of custom software and monitoring protocols.
WAGNER SPRAY TECH • Minneapolis, MN
Software Developer May – Aug, 2005 (Contract)
Led the development of quality control software for monitoring and recording the wattage and calibration of laser
measurement systems mounted on consumer paint sprayers.
EDUCATION AND CERTIFICATIONS
Dunwoody College, Minneapolis, Minnesota
Bachelor of Science, Industrial Engineering ABET Accredited
Honors: Magna Cum Laude and 100% Attendance Award
NEI, Columbia Heights, Minnesota
Associates of Science, Electronics Technology
Institute of Industrial and Systems Engineering, Norcross, Georgia
Lean Six Sigma Green Belt Certification
To contact this candidate email email@example.com