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Medical Device Engineer and Project Manager

Location:
Rockwall, TX
Posted:
March 14, 2019

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Resume:

A. David Smith

**** ********* ***** ********, ***** 75087

404-***-**** ac8sbm@r.postjobfree.com

https://www.linkedin.com/pub/david-smith/6/852/992 MEDICAL DEVICE EXECUTIVE

Strategic Product, Operations, and Business Development Specialist Hands-on, innovative and entrepreneurially-minded executive with 15+ year track record of product development, acquisition, start-up, and turn-around experience in the medical device industry. Broad product knowledge including; catheters, guide wires, drug delivery systems, introducers, and manufacturing of same. Leadership experience in multi-site R&D, manufacturing, marketing, and creation of high performance teams. P&L responsibility for companies from start-ups to established with 20+ million in revenue.

CORE COMPETENCIES:

Leadership: Managed culturally diverse and disparately located teams to execute the correct strategy at the right time. I lead through example and excellence, and pride myself on understanding all aspects of the business from the paperwork to the legal and regulatory requirements. Most recently I provided the onsite leadership for a $20 million division of Theragenics. Marketing: Directed the global marketing efforts for a $12 million dollar vascular products division of a 50 million dollar company. I and my team created the plan which would reverse the reduction in market share the company was experiencing, and turn it into steady growth which continues today. Development: Designed new products, and managed product design teams. I have managed projects with multi-million dollar budgets that have added multiple millions in revenue once launched. I have managed every aspect of the product development process, from ideation to product launch. I am an engineer by training, and bring an empirical approach to finding solutions and building opportunities. LEADERSHIP HISTORY

ADS2 Engineering INC – Rockwall, TX

VP Business & New Product Development 12/2015 - Present Medical device Start-up Company providing new product development & project management services. Galt Medical Corporation – Garland, TX a division of Theragenics General Manager / Research and Development Director, 10/2010–12/2015 Directed operations with P&L responsibility for $20 million global medical device manufacturer of guide wires, introducers, dilators, catheters, and surgical kit packing for interventional radiology, cardiology through direct sales, private label and OEM channels. Manage staff of 250 with 9 direct reports. Work directly with production personnel, quality, engineering, R&D, planning, procurement, logistics, finance, senior staff and marketing to achieve all production objectives on time while implementing continuous improvement and offshoring efforts to reduce costs, improve product quality and launch new products.

PROFIT

MAXIMIZATION

Reduced material costs by 50% through modification of materials choices and suppliers.

Improved lead times, and reduced backorder to historically low levels while keeping inventory flat.

Improved planning and forecasting efforts to reduce costs and stock outs.

Implemented an ERP system to replace a manual management method.

Undertook offshoring of low margin products to Costa Rica & Dominican Republic including setting up a Theragenics facility in Costa Rica.

NEW

PRODUCTS

Launched 5 new products within the first 2 years from a “dry” pipeline.

Created a strategy for new products which included both organic and in-organic growth opportunities.

Re-organized R&D efforts to include multi-site strategy. BUSINESS

STRATEGY

Re-organized operation to position company for future growth.

Created a diversification strategy to reduce channel conflict in sales.

Modified OEM approach to products to focus efforts on highest payback. TransCardiac Therapeutics – Atlanta, GA

President, Chief Technology Officer, 4/2008–10/2010 TransCardiac Therapeutics was a medical device start-up using technology developed at Emory university hospital & Georgia Tech. The technology creates better minimally invasive access for cardiac surgical interventions. The company was taken to the marketing stage and bundled for sale. START-UP

ACTIVITIES

Responsible for funding initiatives associated with new company startup including business plan creation, presentation to investors, negotiations for funding, and creation of strategic alliances.

Responsible for staffing of departments, implementation of quality systems, product registration, design and development of products, and launch planning for new products.

Created and implemented an intellectual property strategic plan, as well as added five additional patents applications to portfolio.

Completed the design, prototyping, sourcing, and testing of the company’s first two products with under $400,000. Achieved first product FDA approval with 510(k) K083218, and second filed 510(k) K091530.

Angiodynamics - Manchester, GA (stock symbol ANGO) Director of R&D / Marketing, 6/1997–4/2008

Held many leadership positions within company, starting with Horizon Medical Products, and through acquisition, ending with Angiodynamics. Managed engineering, manufacturing, and marketing at various times in the company’s growth from a start-up in 1997, through acquisition and integration of other companies, and eventually being acquired twice. DIRECTOR OF R&D

(Angiodynamics

04/2006-04/2008)

Responsible for combining and integrating product development efforts from disparate and culturally different organizations. This process included analysis of projects leading to recommendations as to which projects to keep based on project valuation analysis.

Research and development department activities including budgeting, planning, management of projects, management of engineering team including 3 product development engineers, two process engineers and two technicians.

Developed and implemented a three year product strategy designed to make Angiodynamics the market leader in oncology vascular access. Wrote and successfully cleared 510(k)’s K062414, K062579, K051102, & K050176. Also contributed to 510(k) K072375.

Created new IP including novel designs for vascular access devices and accessories, including design patents D0595892, D644735D650475 & novel implantable catheter (7,740,616, 7,905,875, 9,358,378, 8,926,573) and other pending applications.

DIRECTOR OF

MARKETING &

R&D (RITA

Medical

Technologies

08/200*-**-****)

Responsible for global marketing for $12 million product lines, including 3 product managers, and international operations group located in Belgium.

Created new marketing programs for product lines, shut down non-value added activities, cancelled non-profitable products, and changed sales trends from negative to positive.

Trained international direct sales and distribution representatives.

Managed marketing budget of $1 million and product development budget of $750,000.

Directed the efforts of the product development department during time of market shift, including launches of 4 successful new products.

Wrote 510(k) K0511354.

DIRECTOR OF

ENGINEERING &

MANUFACTURING

(Horizon Medical

Products

06/1997-08/2004)

Primary engineering responsibility for 5 company acquisitions. Handled process/facility designs for required output of transferred processes.

Department added $5,000,000 in incremental sales revenue from new products in 2003 on a

$900,000 budget. Five new products were launched in 2003 including four successful 510(k) approvals.

Developed new IP for the company including Needle safety administration device (Patent # 6,676,633), and Novel vascular access device (Patent Number 6,997,914)

Involved in ISO, CE, and FDA compliance filings, certifications and audits. Assisted in defense of and testified in product litigations.

Managed operations during initial start-up of company, and production ramp up for IPO Managed manufacturing floor with 30 employees. Increased employees to 45 on two shifts.

Handled transfer of acquired companies IP, manufacturing processes, and products. Integrated 5 companies into one facility and one quality system. EDUCATION: Masters of business administration University of West Georgia– Lagrange, GA Bachelor of Science in Mechanical Engineering Florida State University – Tallahassee, FL References:

Joe Plante, formerly President Galt Needletech Email- ac8sbm@r.postjobfree.com Phone: 978-***-**** Mario Martinez, General Manager RITA Medical systems Email ac8sbm@r.postjobfree.com Phone 404-***-**** Bruce Maloy, General Manager Angiodynamics Email ac8sbm@r.postjobfree.com Phone 770-***-**** Dan Recinella, Formerly Director of Engineering Angiodynamics Email ac8sbm@r.postjobfree.com Phone 518-***-****



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