Supply Chain Product Development

KEVIN D. JOHNSON, MBA

aczwfl@r.postjobfree.com / 612-***-**** / linkedin.com/in/kevin-johnson-5bb5512

Accomplished operations and supply chain leader with a global strategic perspective and entrepreneurial spirit. P&L experience and proven results in all aspects of world class manufacturing operations. Expert in lean manufacturing, new product development, quality systems, and global supply chain in the medical device industry.

Extensive strategic experience in medical devices, including complex electro-mechanical equipment, precision CNC components, automated assembly, injection molding, traceability, and sterile packaging for FDA Class II and Class III products.

Hands on experience developing and implementing manufacturing, purchasing and fulfillment from the ground up for 4 companies in compliance with cGMP and ISO 13485 requirements. Expert in make/buy decisions and assessing core competencies.

Successfully led global contract manufacturing, technology transfer and NPI programs in China, India, Europe, and Latin America. Strong background in business development in contract manufacturing and new product development.

Featured speaker on global manufacturing and supply chain strategy for corporate and academic conferences.

A collaborative leader who builds and sustains relationships with customers, suppliers, and colleagues. Strong background in implementing Lean Manufacturing. Subject matter expert in ERP systems, including MS Dynamics, Oracle, and SAP.

AREAS OF EXCELLENCE

FDA Medical Devices Global Supply Chain ERP Systems Cost Reduction

China Manufacturing Quality Management Order Fulfillment Multi-Site Operations

Lean / Six Sigma Profit & Loss Contract Manufacturing CNC Machining

New Product Development Injection Molding Cardiology/Orthopedics Outsourcing

WORK HISTORY

Jukka Group Inc. 2013-present

PRINCIPAL CONSULTANT

Executive consultant focused on helping companies solve strategic manufacturing, operations, quality, and global supply chain issues. Recent engagements include commercialization of a micro-mobile device for diabetes treatment, wireless patient monitoring of brain waves, contract manufacturing strategy, new product development services, medical equipment repair, and ISO 13485 registration.

Vidacare Corporation, San Antonio TX 2010-2013

SENIOR DIRECTOR OF OPERATIONS

Vidacare (acquired by Teleflex) technology allows clinicians to access bone marrow (the intraosseous space) quickly and relatively painlessly: incorporating simplicity, efficacy, patient comfort, and cost effectiveness.

Responsible for the global supply chain, manufacturing, and global order fulfillment with sources in the US, Europe, the Dominican Republic, and Asia. As a virtual company, the entire supply chain and fulfillment process was outsourced.

Designed and implemented the supply chain, purchasing and order fulfillment systems from scratch using SAP.

Moved product manufacturing back to a U.S. contract manufacturer from an offshore source. Result was a cost of goods reduction of 40%, or over $1.7MM in annualized cost reductions.

Successfully developed and implemented warehouses, order fulfilment and customer service centers in the US and the Netherlands, resulting in over $400K in lower costs and 99% same day delivery performance.

Corventis, Inc., St. Paul MN 2008-2010

DIRECTOR OF OPERATIONS

Corventis (acquired by Medtronic) is an emerging growth company focused on the development and commercialization of wireless cardiology and patient health monitoring solutions. The company successfully commercialized two mobile cardiac telemetry products.

Responsible for development and implementation of the commercial design and contract manufacturing of the system. Developed all manufacturing and purchasing processes for the company and successfully met requirements for ISO 13485 registration and FDA 510(k) submission.

Led source selection, contract negotiations and pricing all elements of the system including Chinese sourcing.

Successfully scaled up US and global fulfillment operations and full manufacturing in China for FDA Class II devices.

Augustine Biomedical + Design, Eden Prairie MN 2006-2007

DIRECTOR OF OPERATIONS & SUPPLY CHAIN

A product development company focused on the development of surgical patient temperature management procedures.

Responsible for manufacturing, global supply chain, order fulfillment and warehouse operations.

Led source selection, contract negotiations and pricing for the product. Drove COGS targets $500k below original plan.

Developed all manufacturing and purchasing processes for the company and met requirements for ISO 13485 registration.

Accellent, Brooklyn Park MN 2005-2006

GENERAL MANAGER / DIRECTOR OF OPERATIONS

Accellent (now Integer) is a contract manufacturer of precision cardiology and orthopedic components serving Tier 1 medical device clients.

Responsible for $50 million in revenue and 500 employees in 3 facilities, producing precision machined components, injection molding and laser assemblies for Tier I medical device companies in the world. Developed and implemented plan in 3 months to significantly reduce lead times and eliminate production bottlenecks. Result was a very significant capacity increase, and reduction of lead-times from 18 to 6 weeks.

TriVirix International, Milaca MN 2002-2005

GENERAL MANAGER / DIRECTOR OF BUSINESS DEVELOPMENT

TriVirix (acquired by Nortech Systems) was a contract manufacturer serving the medical device and life science industry. In April 2002, TriVirix acquired a facility from Medtronic and manufactured FDA Class II and III medical devices under multi-year contracts.

In a dual role as General Manager and Director of Business Development;

Successfully transitioned the facility from Medtronic and implemented lean manufacturing processes.

Booked over $20M in new business for the Milaca facility with customers in cardiology, orthopedic and vascular markets.

Customer Driven Machining, LLC, Maple Plain MN 2000-2002

CEO AND FOUNDER

Developed concept to apply web-based content management and advanced manufacturing techniques to the CNC machining market, enabling faster delivery of precision components in a variety of industries. The company closed in 2002 due to VC funding post 9/11.

Entrust Datacard, Minnetonka, MN 1993-2000

SENIOR VICE PRESIDENT, MANUFACTURING and SUPPLIES

Senior executive leading global supply chain, equipment manufacturing, supplies business unit and order fulfillment for $350 million manufacturer of custom equipment for the plastic card industry. Progressive advancement from Production Manager to Manufacturing Director and VP Manufacturing. Direct responsibility for over 500 employees and $100 million in operating expenses.

Increased company profits by over $5 million in 1996 and 1997 through cost reduction programs with key suppliers.

Applying lean manufacturing principles cut lead times on make-to-order, $500,000 equipment from 12 weeks to 5 days.

Led 15% annual growth of $50MM consumable print media business unit.

OTHER RELEVENT EMPLOYMENT

St. Jude Medical, St. Paul, MN 1992-1993

PRODUCTION MANAGER

Led manufacturing of the original St. Jude mechanical heart valve. Key processes included precision CNC machining, pyrolytic carbon and polishing.

The Toro Company, Shakopee MN 1990-1992

OPERATIONS MANAGER

Component manufacturing for commercial heavy equipment and golf course products.

Honeywell Inc., Minneapolis, MN 1985-1990

MATERIALS MANAGER

Led transfer of weapon’s system from Sweden to the U.S. Responsible for $30MM budget and global supply chain. Previously, manufacturing engineering support for high volume ammunition manufacturing, including high volume assembly and injection molding.

3M Company, St. Paul MN 1981-1985

PROJECT ENGINEER

Project engineer for commercial packaging products. Managed over 50 capital projects.

EDUCATION

MASTER OF BUSINESS ADMINISTRATION Carlson School of Management, University of Minnesota

BACHELOR OF MECHANICAL ENGINEERING Institute of Technology, University of Minnesota

Contact this candidate