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Accomplished Executive with a track record of success in high growth global manufacturing. Extensive experience in managing within the highly regulated medical device manufacturing sector. Experience ranges from small high growth companies to fortune 500 companies. Well versed in global manufacturing strategy planning and execution. A respected leader who can quickly assess, plan, and implement change for favorable business results. • Results-focused, people-oriented, process-based and data-driven.• Consistently assigned to business challenges requiring complete turnaround and rapid growth.• Continuously improved customer satisfaction and profitability using Lean and Six-Sigma approach.• Extensive experience in systems development. • Led multiple plant expansions, consolidations, and integrations. • Considerable involvement in multiple Mergers and Acquisitions • Great experience and results in global manufacturing including successful low cost start up in MexicoSpecialties: Medical Device Manufacturing, ISO 13485Lean Manufacturing, Six SigmaManufacturing Integration, Mergers and Acquisitions Global Manufacturing
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Vice President OperationsAxogenSaint Paul, Mn, Us -
Board MemberTiumed Llc Apr 2018 - PresentGreater Minneapolis-St. Paul Area -
PrincipalLead 2 Change Consulting Jan 2013 - PresentTwin Cities Minnesotawww.Lead2changeconsulting.com On-Demand Executive Leadership• Strategy planning and implementation• M&A Due Diligence • Lean and Six Sigma Implementation • Integration and outsourcing • Global Operations -
Board MemberApyx Medical Mar 2018 - Nov 2024Tampa/St. Petersburg, Florida Area• Global Manufacturing Strategy advisor • Audit Committee • Regulatory Compliance Committee• Extensive involvement in carve out sale of core business (Bovie Medical)
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Vice President Of OperationsTendyne Holdings (Aquired By Abbott) Jan 2015 - Oct 2016Greater Minneapolis-St. Paul AreaA clinical stage medical device company focused on the development of minimally invasive therapies for the treatment of mitral regurgitation. Acquired by Abbott Labs in September of 2015 VP Operations Member of executive leadership group. Accountable for operational development and growth.• Responsible for process development of state of the art bioprosthetic heart valve and its delivery system.• Hired key technical personnel to develop manufacturing processes and ramp production. • Ramped manufacturing from first in human implants into CE clinical trial. • Managed the doubling of company footprint and expansion of IT and other infrastructure systems. • Successfully contributed to the sale and transition of the business to Abbott Labs.
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PresidentMeier Tool And Engineering Jan 2011 - Feb 2012Anoka MnPrivately held Manufacturer of tight-tolerance, critical-to-function, metal-formed components and sub-assemblies for demanding applications in Medical and Defense markets Full P&L responsibility for privately held business – Finance, Sales, Marketing, Quality, Operations, HR, Engineering. • P&L performance. Strategic financial business planning / forecasting and analysis• New business and technology development. • Product and Tool development and Program Management• Left the company in March of 2012 for a start up opportunity that failed within the first few months of my joining due to investor issues.
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Vp OperationsAts Medical (Aquired By Medtronic) Aug 2008 - Nov 2010Manufacturer of state-of-the-art cardiac surgery products and services including mechanical and bio-prosthetic heart valvesMember of executive leadership group reporting to the CEO. Accountable for operational stability and improvement. Eliminated ten week backorder on primary product line within first five months. • Led an Enterprise wide cultural transformation that focused on high performance and achieved significant organizational improvement. • Deployed Lean throughout organization. Reduced COGS significantly and improved all major business processes. • Reorganized manufacturing into value streams to enhance business franchise effectiveness. • Re-Deployed ERP system in three manufacturing locations.• Developed plan to transition a portion of manufacturing to several countries in Latin America. Plan was to be initiated in 2010 but was shelved due to Medtronic Acquisition • Participated in completion of first long range strategic plan for the company. • Significant involvement in M&A activity.
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Sr. Vp Global OperationsGyrus Acmi (Aquired By Olympus) Aug 2005 - Aug 2008Accountable for operations globally for Gyrus Group PLC reporting to the CEO. Responsibility included 12 operation facilities in 8 countries with combined revenues of $450 million. • Responsible for 10 direct and over 900 indirect reports. These groups provided and supported over 8,000 disposable and capital good end items sold to hospitals and clinics.* Responsible for bringing two diverse businesses together to create one global operations unit. • Developed and executed plan that consolidated Manufacturing from 12 to 3 plants. • Developed and executed plan that created a consolidated distribution, customer service, and service and repair center in US and consolidated distribution activity in Europe. • Started up low cost Greenfield plant in Mexico. Plant employed 150 employees within first 18 months and was producing major product lines from 3 different manufacturing plants. • Transferred very large and important product line to a contract manufacturer. • Facility in Connecticut won the Connecticut Shingo prize for operational excellence. • Engaged with R&D, Sales, and Marketing to launch over 20 new products across divisions. • Part of team that successfully sold business to Olympus for $2.2B or 37% Premium.
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Vp OperationsGyrus Medical 2001 - 2005Accountable for manufacturing operations including related functions such as Quality Control, Production, Purchasing, Master Scheduling, and Shipping/Distribution. Promoted to VP after two years• Effectively managed operations through period of exceptional growth. Production volume tripled and headcount doubled during first 2 years of employment. • Worked closely with Quality and Regulatory to assure highest quality possible. Passed numerous internal and external audits including those conducted by FDA, TUV, Guidant, Johnson and Johnson, and C.R. Bard • P&L Accountability for Partnered Technology business. Primary executive in charge of developing and selling products and technology to Guidant, Johnson and Johnson, and C.R. Bard. •Restructured entire Supply Chain organization which then went on to implemented Kanban system throughout Supply Chain. Inventory turns improved from under 3 to 10 in less than 2 years and achieved significant cost reductions from the supply base. • Led production group through Lean / Sigma implementation. This group improved overall production Efficiencies by 50 percent in last three years, reduced floor space, and reduced scrap by 90 percent. • Operations group won the Manufactures Alliance “Manufacturer of the Year” award in the Twin Cities. This award recognizes excellence in Lean Manufacturing implementation.
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Vp OperationsSilent Knight (Aquired By Honeywell) Aug 1995 - Aug 2001Top manufacturing management position reporting to the President of a $30 million dollar company. • Accountable for operations including Quality Control, Test Development, Production, Purchasing, Master Scheduling, Shipping/Distribution, Customer Service, and Facilities.• Successfully worked with Sales/Marketing, Engineering, and Finance, to more than double annual company revenues and improve gross margins from 30 percent to 50 percent.• Advocated and effectively changed the organization environment to a cross functional, team-based organization which produced positive results. • Selected and implemented a major Enterprise Recourse Planning (ERP) system. Received excellence award for implementation success by ERP supplier. • Consistently motivate and lead Operations employees toward excellence in all aspects of production, quality, and performance. Utilized “Lean Manufacturing” and Six Sigma methodologies to achieve operational efficiencies.
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Production ManagerUnisys Mar 1981 - Aug 1995
Craig Swandal Skills
Craig Swandal Education Details
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M-Mba In Medical Technology -
Ba Organizational Management -
De VryElectronics
Frequently Asked Questions about Craig Swandal
What company does Craig Swandal work for?
Craig Swandal works for Axogen
What is Craig Swandal's role at the current company?
Craig Swandal's current role is Vice President Operations.
What is Craig Swandal's email address?
Craig Swandal's email address is cs****@****ail.com
What is Craig Swandal's direct phone number?
Craig Swandal's direct phone number is +176341*****
What schools did Craig Swandal attend?
Craig Swandal attended University Of Saint Thomas, Concordia University-St. Paul, De Vry.
What skills is Craig Swandal known for?
Craig Swandal has skills like Cross Functional Team Leadership, Six Sigma, Lean Manufacturing, Medical Devices, Manufacturing, Strategy, Strategic Planning, Start Ups, Management, Iso 13485, Leadership, Operational Excellence.
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