JAYME D.

PATTERSON
Seymour
TN. 37865

jaymedpatterson@gmail.com
Cell: (865) 607-7177

Objective
My objective is to use my leadership and experience in management of injection molding and automated
assembly to strategically and tactically lead a team to success as a Director of Operations.

Summary of Qualifications

30 Years Operations
Experience
Green Belt
Robotics
Injection Molding
Automated Assembly
Extrusion
6 Sigma through SPC
Kaizen Event Leader

Value Stream Map

Leader
Zero Based Budgeting
Managed 500+
personnel
Communicates / Lives
by KPIs
Strategic Vision

Tactically reduce scrap

and waste
Manage Engineers
Customer focused
1 Patent
Coach
FDA Interface (6 audits
0/483s)
Problem solver

Education
1984 College of the Ozarks - Point Lookout, MO. Bachelor of Science - Biology, Physical Education
1981 Crowder College - Neosho, MO. Associates Degree - Biology, General Studies

Training /Achievement / Certification

Trained and experienced in concepts of Kaizen, lean manufacturing, and Six Sigma.
Green Belt
Patent # D612,513 Dialyzer Universal Cap
Attended numerous personal development and management courses.
Experience using PC and PLC based programs as well as SAP and AS400 applications.
Winner of the 2004 Baxter Distinguished Corporate Contribution Technical Award.
Trained as instructor for 7 Habits of Highly Effective People
Quality Systems Requirements for Medical Devices (QSRs)
Several FDA seminars on cGMP, Device - 21 CFR Part 820, and Pharmaceutical Parts 210 and 211.
Numerous other training.

Experience
2006 2016 FRESENIUS MEDICAL CORPORATION
Director of Operations, Plant Manager, Knoxville TN
Management responsibilities included: Direct the demolition and construction of a 270,000 square foot pharmaceutical
manufacturing facility. Managed the construction and installation of cooling towers, chillers, water softeners, UV, RO
tanks, vapor compression still and the fill lines. Directed the installation of HVAC and construction of two ISO class 8, 7,
6, cleanrooms, Micro Lab, Sterility Suite, and Chemistry Lab. Ran the operation without a Quality counterpart for over a
year until a Quality Director was placed. Developed the Design Qualifications, and Master Validation plans. Met with
FDA (Washington D.C) to communicate development of a new facility. Transferred and installed the equipment from
Ogden Utah and wrote the user requirements for a new fully automated solutions line. Hired staff that included the
Engineering manager, technicians, maintenance, utilities, and 4 Engineers. Helped to bring on temporary staff and
assisted in vetting the Quality Systems staff.
Director of Solutions, Saline, Connectors, PD, Ogden Utah
Management responsibilities included: Direct the operation of 3 departments; Saline, Connectors, and Peritoneal
Dialysis. Produce 36MM one-liter Saline bags and 16 MM PD bags annually. Installing one fully automated PD line that

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equals $6 million in savings. Ran the operation without a Quality counterpart for over a year. I was the interface for an
FDA audit and no 483 were issued. Reorganized the maintenance staff to be more productive without adding
headcount. Increased production from 9 MM to 17 MM bags annually without adding exempt staff. Increased OEE
from 73% to 89% in two years. Directed numerous Kaizen events and value stream maps to set direction and identify
projects for the organization. Implemented Behavior Based Safety with a reduction in all safety metrics. Trained and
maintained process quality and implemented vision measurement systems integrated with SPC software applications.
Reduced scrap 3.2% and increased the CPK of all products with a continuous focus on the quality infrastructure while
maintaining compliance. Positively changed the culture from a complacent attitude, to a rapidly changing attitude that is
not afraid to take calculated risk. Developed the staff to embrace change and to increase their own circle of influence to
affect the bottom line. Together we have delivered over $10 million in VIPs. Responsibility: 34 salaried exempt, 495
direct, 27 indirect staff. Creating and administering a $22 million capital and $38 million department expense
budget. VOP = $1.1 billion.
Director of Molding, Molding for Dialyzers and Saline
Management responsibilities included: Direct the production from 47 injection molding machines, process and product
development, and scale up of dedicated automation equipment. Completed two room expansions including the
installation of 18 injection molding (80 ton to 300 ton) presses, ancillary equipment, and automated robotic packaging.
Installed a new dryer system and automated tote handling system. Implemented de-coupled (Scientific) molding
techniques and the subsequent training. I was the interface for an FDA audit and no 483 were issued. Maintained
process quality and implemented vision measurement systems integrated with SPC software applications with a
continuous focus on the quality infrastructure while maintaining compliance. The third room incorporated Automated
Guided Vehicles (AGVs) to interface with the press automation to deliver totes in and out of the room. Developed and
patented a Dialyzer cap. Together we delivered over $5 million in VIPs, and implemented new validation methods for
the molding area. Responsibility: 4 salaried non-exempt employees, 12 salaried exempt, 63 direct, 16 indirect
staff. Creating and administering a $ 5 million capital and $10.2 million department expense budget. VOP = $15 million

1986 - 2006 BAXTER HEALTHCARE CORPORATION, Mountain Home, Arkansas

Production Manager, Alyx Blood Separator - Medical Device
Management responsibilities included: Concurrent development and scale up of flexible automation equipment utilizing
lean principles through multiple Kaizen events. Installation of five dedicated right sized injection molding presses,
robotic automated assembly and E-Beam Sterilization. Ensured that all equipment maintained current APQP and IQ,
OQ, PQ validation packages. Helped to design and install over $27 million in automation from the floor and walls to the
pack-out area. Developed an over achieving staff in the latest robotics and sterilization. I was the interface for an FDA
audit and no 483 were issued. Managed plant capital improvement projects, programs, and driving key projects to
completion. Interfacing with management, Black-Belt engineers, Engineering staff, and hourly employees as well as
divisional R&D / manufacturing, counterparts, while driving quality and cost savings projects. Established a 5-Year
plan, capital budgets, set priorities, and led problem resolution teams. Responsibility: 53 - direct indirect staff. Creating
and administering a $ 2 million capital and $1.5 million department expense budget. VOP = $15 million
Production Superintendent, CS-3000 Assembly, Filling, and E-Beam manufacturing operations.
Responsibilities included: Developed operating budgets, interfaced with management and hourly as well as divisional
counterparts, drove quality and VIP projects through the Business and Quality plan. Set priorities, led problem
resolution teams, directed activities of team members to ensure schedules, cost, scrap, release goals, and quality
standards were met. Reduced IPMs by 15% and DPMs by 10% each year. Developed and drove particulate removal
projects for meeting Japanese customer requirements. Projects included: a wall to segregate a Worksmart area,
installed an air shower, additional cleaning and personnel garment changes, HVAC upgrades and ionization planning.
Implemented an on-line printing of batch specific information, and bar code scanning in the E-Beam sterilization area.
Drove the upgrade to the Filling rack room and mix and fill room with a new HVAC system, upgraded drains, walls,
floor, and a system requiring less floor space. Initiated empowerment teams in all areas. Responsibility: administrative 4, indirect - 11, direct 208. VOP = $11 million.
Production Superintendent, Overmolded Needles, Fistula, Plateletcell Manufacturing areas
Directed and coordinated the Insert Molded Needles, Fistula and Plateletcell manufacturing areas responsible for
multiple shift operation and product lines. Key accomplishments included: Development of new bevel geometry to

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reduce the amount of pain and make a more robust needle stick. A new grinder controller was developed and installed.
Submitted a next generation needle project, which included a needle to be used for Fistula, and Donor needles that
included a retractable needle shaft. A 17-gauge needle was developed and introduced successfully. Drove molded
scrap down with SPC. Responsibility: administrative - 2, indirect - 9, direct 65. VOP = $15 million
Production Supervisor, Overmolded Needles
Key accomplishments included: Developed and implemented conversion to Double Plug Ultra-Thin Wall Cannula.
Managed successful transfer of Plateletcell to Mountain Home from the California plant. Produced and managed
successful Fistula Field Trail for Renal Therapy. Reduced cycle time of Overmolded needle machines. Reduced Freon
consumption by 30%. Responsibility: direct - 9, indirect 50. VOP = $10 million
Quality Management Supervisor, Needles
Directed and coordinated the Needles and Fistula areas during the period between 1989 and 1991, on first shift
tracking quality indicators including DPM, IPM, Cp, Cpk. On third shift from 1986 to 1989, responsibilities also included
E-Beam, Drug Delivery, Capillary Flow Dialyzers, Wash Room and Cell Separator. Key accomplishments included:
Working with Sterling Stainless, SFM to develop and benchmark processes. Implemented scrap trending of all
manufacturing stages. Developed and implemented an In-Vitro test using human blood to test needle flow.
Implemented Statistical Process Control in the Needles area. Traveled to and worked with West Company, Sterling
Stainless, Baxter Pharmaseal, SFM, Knoll and Applied Science Division to develop quality improvements and define
requirements. Visited numerous accounts and customers at Maricao, Puerto Rico, to work on problems and gain
greater expertise. Conceived and validated grinding computer program to convert manual control charting to
computer-generated data reducing variation. Implemented audit system in Overmolded needles room. Participated
and led various Quality Leadership Process teams and activities. Number of Reports: Indirect - 6

*REFERENCES AVAILABLE UPON REQUEST*