KEITH THEISEN

Blaine, MN 55449 763-273-0100 keith.theisen@gmail.com LinkedIn: http://www.linkedin.com/in/keiththeisen

PROFESSIONAL SUMMARY
Accomplished product development professional with 17+ years of leadership experience including engineering, operations and finance in both medical device and high tech industries. Product development and manufacturing experience in ISO (9001 and 13485) and FDA QSR environments. Actively project managed over 40 projects with revenue in excess of $5 million dollars. Proven ability to bring product ideas through the product development process and into successful commercialization. 6 years of financial leadership for small to medium sized businesses. Creative problem solver who enjoys being part of the discovery and creativity processes of product design, and working with and developing a team of people.

WORK HISTORY Worrell, Inc.; Minneapolis, MN 01/ 2008 01/2012

Worrell is an international product development firm serving medical, consumer, and industrial OEMs. Vice President of Operations and Finance Senior Executive responsible for the Operations and Finance of the company of 35 people in Minneapolis, MN and Shanghai, China. Also a contributing Program Manager for the consulting side of the business. Worked closely with our CEO on company strategy, marketing and planning to develop annual goals and objectives which resulted in 15% year on year revenue growth the past two years. Successfully led the company through a process of working with banks to restructure debt and bring in new capital to the business, worth over $300,000. Directly participated in closing over $2,100,000 in new project work with clients. Project managed over 25 development projects with over $1,850,000 in revenue, using an efficient and creative development process. These projects included 12 medical device programs. Led the effort to research and implement a new 401(k) plan to reduce company expenses in the plan and improve retirement benefits for the employees. Established and maintained the financial protocols between our China office and US holding company. Our China group went from $0 in revenue to profitability in 3 years.

Evo Medical Solutions (now Global Medical Holdings); Adel, IA 03/2004 01/2008
Evo is a medical device manufacturer in the home healthcare industry, focusing on respiratory and sleep diseases. Vice President of Operations and Engineering 06/2007 01/2008 Plant manager with profit and loss responsibility for the companys medical device production and distribution facility. Yearly sales over $30 million and average monthly shipments of 30,000 pieces. Led the daily operations of the facility, including direct responsibility for the Engineering, Quality, Production, Materials, Distribution and Customer Service teams, with 5 direct reports. Set the priorities for the operation, controlled expenses and worked closely with Sales to create the manufacturing plan to meet the sales requirements, and ensure the company complied with the FDA regulations and ISO 13485 standards.

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Director of Operations and Engineering 03/2004 - 06/2007 Manager of the Product Development, Manufacturing Engineering, Production, Materials, and Distribution teams, with 7 direct reports. Located a new Taiwanese Medical Device partner, qualified them and successfully launched 2 Nebulizer products and a line of sleep accessories into the US market, generating over $750,000 a year in annual revenue. Led the team that researched and implemented the Agile Quality Management Software into the company. This implementation improved our regulatory compliance as well as improved the accuracy and efficiency of our quality processes including improving our Engineering Change Order Process time by over 50%. Developed and implemented FDA and ISO Quality procedures, including Design Control, Change Control (ECO), Risk Management, and Purchasing. Led the team that utilized lean manufacturing principles to re-lay out the production and distribution operation. This change improved material flow and reduced inventory. Led the project team to develop and launch a new Heated Humidifier within the FDAs QSR regulations and ISO 13485 standards. Included 510(k) and CE mark approvals. Successfully handled the direct communication with the FDA Inspector and FDA Compliance Officer through two FDA site Inspections and the corresponding follow-up conversations. Successfully led the companys efforts to close out a FDA 483 Report, Warning Letter, and 2 Product Recalls.

Worrell, Inc.; Eden Prairie, MN

07/2000 03/2004

Worrell is an international product development firm and acquired Virdev in May, 2003. Virdev was a product development firm and was located in Eagan, MN. Senior Project Manager 05/2003 03/2004 Project managed and successfully delivered the $2 million medical device project as well as four additional projects valued at over $300,000. Managed the outsourced supply chain of manufacturing and prototyping vendors; including assembly, tooling, injection molding, sheet metal, and a variety of prototype services. Modified the product development process for Worrell to include Engineering and Program Management services. This led to longer engagements with clients, thus increasing revenue and becoming a bigger part of the clients business. Operations and Finance Manager (Virdev, Eagan, MN) 12/2001 05/2003 Manager of the Program Management, Engineering, Finance, and Administration Departments with a team of 10 people. Responsible for profit and loss of all development projects, with yearly revenue of $2.5 million. Project managed the $2 million mechanical development portion of a large medical OEMs medical device project. Project included over 50 custom mechanical parts, including injection molding, sheet metal, machined parts, labels, and cable assemblies. Project Manager (Virdev, Eagan, MN) 07/2000 12/2001 Led the mechanical product development activities of several medical and industrial products valued at over $4 million in engineering and tooling services. Managed the activities of our engineering team and outsourced supply chain and was responsible for the profit and loss of the projects.

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MCMS, Inc. (now Plexus); Nampa, ID

07/1999 07/2000

MCMS was an electronics contract manufacturer and was later acquired by Plexus. Business Unit Manager Manager of the Program Management team with 6 direct reports. Profit and loss and customer service responsibility for the customer accounts within the Systems Assembly Business Unit. Business Unit manufactured high end networking equipment for leading technology companies. Expanded the business in one year from $50 to $120 Million in yearly revenue by winning three new customers and by expanding the business with existing customers. Provided sales forecast and working capital requirements to the finance department. Worked closely with the external Sales team to ensure profitability and win new accounts.

Artesyn Solutions (now Solectron); Lincoln, CA

10/1995 06/1999

Artesyn Solutions was a manufacturing and distribution subsidiary of Artesyn Technologies and was later acquired by Solectron. Business Unit Manager 03/1998 06/1999 Manager of a computer and peripheral manufacturing operation with 150 people, including 7 direct reports. Complete profit and loss responsibility for the Business Unit, including management of the Engineering, Production, and Material functions. Integrated three different Business Units into one, reduced costs, returned business groups to profitability, and increased production efficiency. Turned a negative customer relationship into a positive and productive business relationship by developing a solid organization and earning the customers trust, which kept the business with our company. Engineering Manager 01/1997 - 03/1998 Managed the Engineering, Quality, Documentation Control, and Training groups for the manufacturing facility with 4 direct reports and a total department of 35 people. Recruited and developed a technical staff that supported the manufacturing Business Units. Managed the manufacturing facilitys space requirements and factory line layouts using Lean Manufacturing Principles. Manufacturing Process Supervisor 02/1996 01/1997 Supervised the Engineering and Quality staff of 10 people for a manufacturing Business Unit. Set up new manufacturing lines using lean manufacturing techniques to accommodate the growth in several product families. Produced statistical sampling and other quality auditing methods for the production groups. Manufacturing Process Engineer 10/1995 - 02/1996 Developed procedures, processes, tooling, line layouts and overall material flow for a new 100,000 square foot manufacturing facility, including several new product introductions.

Graco, Inc.; Arvada, CO

06/1994 10/1995

Graco is a manufacturer of fluid handling equipment that serves the contractor, industrial and commercial markets Assoc. Product Development Engineer Worked in the design and test lab as part of the development team for the Contractor Equipment Division, developing new paint sprayer technology.

EDUCATION
Master of Business Administration (MBA) Bachelor of Mechanical Engineering with Management Minor University of Phoenix University of Minnesota