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Barry J. Smith 108 West Clay Creek Lane Kennett Square, PA 19348 [email protected] (610) 766-1090 (C) Summary: Medical Device Executive with twenty-seven years of diverse, progressive leadership experience utilizing business development, technical, financial and strategic management skills to achieve solid business results… Thrive working in fast paced and rapidly changing environments…. Well-organized, entrepreneurial, results oriented leader with strong communication, team building and interpersonal skills…. Relevant industries include Neuromodulation / Neurostimulation, Cardiovascular, Orthopedics / Spine, Wound Closure / Stapling and Laparoscopic / Endoscopic Devices, Polymer, and OEM Custom Designed / Engineered Products. Qualifications: EBITDA Growth P&L / Capital Management Strategic Customer Mgmt. / Business Development Acquisitions / Joint Ventures Multi-Facility Mgmt. Market & Sales Development / Mgmt. Equity Partner Funded Businesses Lean / Cellular Manufacturing New Product Development Multi-National Team Leadership Contract Negotiations Continuous Process Improvement Board Membership Start-Up / Change Mgmt. Cross-Cultural / International Group Mgmt. FDA / GMP Regulated Industries – ISO-13485 Six Sigma / Lean Mfg. Experience: BSM 2011- Present Principal BSM is a medical device and biotechnology consultancy helping clients succeed in a rapidly changing and highly competitive marketplace; using twenty-seven years of business expertise and industry experience, BSM assists organizations in avoiding missed opportunities in strategy development; planning, product launch and execution. CIRTEC Medical Systems 2009 – 2011 President & Chief Executive Officer CIRTEC is a leading provider of “single sourced solutions” to the medical device industry for outsourced design, development and manufacturing solutions. Utilizing its three locations in San Jose, CA, Springfield, MA and Minneapolis, MN, CIRTEC provides its customers a complete solution across most device markets but with particular specialization in both passive and active devices for the neuromodulation, cardiovascular, orthopedic and MIS/NOTES. The Company was formed from the successful merger of Texcel Medical and Circle Medical Devices in October of 2009. Responsibilities include Director on Management Board, P&L / Capital, Business Development, Research and Development, Engineering and Program Management. Accomplishments include: Completed successful recapitalization in Nov. 2010 with an IRR in excess of 45% Completed successful merger and integration of Texcel and Circle in Oct. 2009 Improved EBITDA performance by 100% FY 2009 & 2010 Year over year sales growth of 15% Restructured quality and sales groups to improve customer satisfaction and sales team performance Improved internal COGS by 25% Lead implementation of costing model that allowed organization to function in both the low cost manufacturing area and the custom design markets Amedica Corporation – US Spine 2009 – 2010 Board Member US Spine Served as an active board member to US Spine, Inc.; who develops, manufactures and distributes spinal implants and instruments. The company offers cervical, interbody\VBR, and facet systems, as well as thoracolumbar systems, such as preference spine and facet fixation systems; and biologics, such as element bone graft substitutes. The company was founded in 2003 and is based in Boca Raton, Florida and had a successful exit to Amedica Corporation in September 2010. Synectic Medical Product Development 2004 – 2009 Chief Operating Officer A clinically focused outsourced medical device product development and engineering company that works with many of the world’s largest medical device and biotechnology companies. Our client list includes Medtronic, Johnson & Johnson, C.R. Bard, Becton Dickinson and Boston Scientific to name a few. Synectic participates on twenty-five to thirty projects annually. Responsibilities include the day to day business operations, P&L, business development & contract negotiations, project management and client management. The following are selected results: Achieved 20+% year over year sales growth Created branding & marketing plan to facilitate growth Refined project management and reporting to improve on-time and on budget performance to 98% Created human resources manual, review process and performance based reward program Achieved customer satisfaction rating of 95% Completed facilities expansion to enable continued growth to meet ever-changing customer and vertical integration expectations Power Medical Interventions 2002 - 2004 Vice President of Operations / Product Development Innovative medical device company offering advanced surgical products incorporating computer-mediated and robotic technologies, revolutionizing both open and minimally invasive surgery. Responsibilities include: Development and execution of strategic and tactical plans for the company Strategic Vendor and Supply Chain Management - negotiated multi-year contracts to achieve desired partnerships, long-term supply, and COGS/Service objectives Leadership role to overseeing new product development teams – introduction of 4-6 new products per year Created strong alliances with virtual manufacturing partners to achieve COGS targets and exponential sales growth Implemented ERP System. Provided hands-on leadership and created strong customer service organization Scaled production to meet 100% sales growth while eliminating a chronic, aging backorder Innovative Gas Systems - Separation Technologies 1998 - 2002 Vice President – Innovative Gas Systems 2001 - 2002 Provided leadership for consolidated company created by merging four technology companies, Generon (USA), Mahler (Germany), Italfilo (Italy) and SMC (China) that together offer the most complete line of separation technologies on the market today. Responsibilities include P&L, Global Technology Development, Generon® Product Line Management, Global Quality System Oversight, and Manufacturing / Operations for locations in Houston, TX, and Pittsburg, CA. Significant accomplishments include: Completed an MBO of Generon and three other companies, principal member of management team Developed and commercialized new membrane product Transferred technology from Europe to USA to expand product-line while lowering COGS by 25% and improving reliability and performance General Manager – Generon 1998 - 2001 Led a business that globally markets, sells and manufactures custom designed and engineered OEM systems, utilizing membrane and adsorption technologies. Responsibilities included full P&L, Research and Product Development, Sales and Marketing and Manufacturing, for locations in Houston, TX and Pittsburg, CA. Significant accomplishments include: Sales Strategy Shift – resulting in segment growth of 25%/yr Created JV for the globalization of products Achieved ISO-9001 (three site certificate) Successfully acquired technologies to expand product lines; also awarded 6 patents. Reduced COGS by $1.6 MM since 1998 Sorin Group - COBE Cardiovascular – Oxygenator Group 1995 - 1998 Manufacturing Director 1996-1998 Led a $70 MM business unit that manufactured Class III Medical Devices for use in heart bypass surgery with compliance to FDA/GMP. Fully responsible for business unit P&L and operating expense. Functional areas included Manufacturing, Product/Process Engineering, Materials, and Maintenance/Engineering, accounting for approximately 450 employees. Significant accomplishments include: Reduced costs by $5.7 MM during 1997/1998 Improved productivity by 30%, utilized cellular manufacturing and demand flow to improve process Reduced total inventory by $4.6 MM and increased finished goods turns from 3.4 to 18 Improved product yields resulting in a $160 K/month savings Manufacturing Manager 1995-1996 Managed a business unit responsible for manufacturing 275K Oxygenator units annually. Direct responsibilities included Manufacturing and Materials (Finished Goods, PIC, Staging), accounting for approximately 300 employees. Significant accomplishments include: Successfully assisted in the prevention of a union environment Restructured product line offering, decreasing COGS by 25% Improved customer satisfaction by reducing complaints 30% Reduced costs by $1.3 MM during 1996 (with a 7% increase in sales) Johnson Matthey - Catalytic Systems Division 1985 – 1995 Manufacturing Manager 1993-1995 Responsible for the coordination of operations in multiple departments of a Catalyst Manufacturing Plant, which produced 18-20 MM units per year. Departments included Production, Quality, Material Control, Sample Production Group, Plant Logistics, and Environmental Products, accounting for approximately 200 employees. Responsibility for operating P&L, operating budget of $156 MM and precious metals totaling $350 MM per year. Accomplishments include: Decreased cost of nonconformance by 15% annually Improved chemical utilization and environmental costs by $350K Utilized ergonomics to redesign work stations and reduce Lost Time Injury rate by 25% Reduced process defects by 35%. Increased raw material utilization by 6%. Reduced system changeover time by 25% Received Ford TQE - one of only five awarded to suppliers Improved batch quality by 27%. Improved sample time by 20% Standardized operating systems through training, documentation and measurement Quality Manager 1990-1993 Provided operational leadership and manufacturing support for a three-shift catalyst production facility. With a staff of 45 managed both Quality Control and Quality Assurance departments to meet internal and external quality requirements. Active application of the quality improvement process resulted in improved performance and efficiency. Significant accomplishments include: Streamlined quality operations resulting in increased productivity of 20% and a staff reduction of 10% One of only 13 companies to supply Chrysler that achieved Pentastar Award consecutively since 1985; received Platinum Pentastar first year awarded; Recipient of Ford TQE Award since 1989 Coordinated and achieved ISO-9002 registration in ten months Implemented $1.8 MM in instrumentation and facilities upgrades Other Positions Held at Johnson Matthey 1985-1990 Production Manager / Production Superintendent / Process Control Supervisor / Production Engineer / Process Control Engineer Niagara Aromatics, Inc. 1984 – 1985 Systems Engineer Developed processes and equipment lay-out for start-up organization to manufacture custom chemical intermediates. Responsibilities included scale-up of products from pilot plant to production quantities. Supervised five skilled trades people in installation and operation of equipment. Education: BS Chemical Engineering, 1984; State University of New York at Buffalo Training: Financial Management for Non-Financial Executives The Management Course; Four week accelerated management program Statistical Process Control & Statistics for Non-Statisticians Kepner Tregoe - Problem Solving and Decision Making Other: Founding member of Newport Rowing Club; Newport, DE