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David M.

Winer, PMP
(508) 404- 4833 dwiner@ieee.org _____________________________________________________________________________________ Rockville, MD

Program Management Executive


Product Development Leader and Strategist Big Picture Vision - Detail Oriented Focus Navigating Roadblocks to Success
Aligning Development and Corporate Goals | Turning Around Distressed Projects

Focus development teams with leadership & clear goals to energize development efforts Open communication lines to cross-functional team participants to assure commitment Establish product requirements and develop product and project risk profile Directed a multi-million dollar molecular diagnostics instrumentation and assay product development program utilizing the phase gate process leveraging both in-house and contract development resources for QIAGEN delivering breadboards in record time Success Drivers Competencies Leadership Big Picture Vision Detail Orientation Decision Making Influence without Authority Negotiation Results Orientation Integrity Listening Problem Solving Analytical Thinking Skills Certified PMP Six Sigma Green Belt Project Management Presentation Risk Management Troubleshooting Systems Engineering Human Factors Engineering ISO 13485 21 CFR Part 820 QSR Microsoft Project

Technology leader with broad technical knowledge combined with outstanding leadership ability and creative problem solving skills. Proven track record leading concurrent projects under FDA regulations with multidisciplinary and multicultural cross-functional staff in a core team structure. Highly successful in building and sustaining relationships with customers and all organizations levels from senior executives to individual contributors. Possesses the technical acumen to fully understand voice of the internal and external customer. Major strengths in team focus, project strategy and goal planning, resourcing and level headed troubleshooting resulting in new business and shorter times-to-market. Sound knowledge of FDA QSR, ISO design controls, risk management and IEC 60601 safety standards. Maintains strong sense of accountability and responsibility in accomplishing organizational goals.

David Winer GLENWOOD ASSOCIATES, Rockville, MD


Navigating roadblocks to success

-22011-Present

Project Management Consultant


Turn distressed projects into successful product deliveries via focused leadership Direct critical FDA regulated instrumentation development projects with a cross-functional core team structure assuring project plan adherence and regulatory compliance Manage project activities at OEM developer sites and internally under ISO 13485 and FDA QSR Strategize with clients to conduct projects with compliance and managed risk

QIAGEN CORPORATION formerly DIGENE, Gaithersburg, MD


The DIGENE HPV test

2006-2010

Director, Program Management Associate Director, Instrumentation Programs


Directed the largest MDx instrumentation development program in company history under FDA class 3 device guidelines assuring adherence to product requirements Led contract developer & manufacturer selection team and coordinated product development under ISO 13485 medical device standard, ISO 14971 risk management standard, IEC 60601 safety standards, and 21 CFR Part 820 QSR Directed system level verification and validation planning and execution assuring minimal test failures

KRONOS INCORPORATED, Chelmsford, Massachusetts


Most trusted name in workforce management systems

2003-2005

Senior Engineering Manager


Delivered product early, enabling sales to exceed goals in the quarter of release Managed all scheduling projects and release engineering within the corporate suite of products Led a highly focused group of software engineers in the development of a unique automated workforce scheduling product with focus on high quality and delivery within a small window of opportunity

EMC CORPORATION, Hopkinton, Massachusetts


World leader in automated networked data storage

1997-2002

Senior Engineering Manager


Built 2 groups of 6 software developers and systems integrators and organized into a cohesive team with concrete goals, thereby increasing productivity Grew yearly revenue from $30M to $100M in three years via new product releases and enhancements

David Winer Senior Program Manager

-3-

Created communication links between previously isolated development teams responsible for $1Billion in sales thereby reducing redundancy and improving overall effectiveness and times-tomarket Scheduled and controlled product development activities and reported to executive management regularly to improve decision making effectiveness

NOVA BIOMEDICAL CORPORATION, Waltham, Massachusetts


Manufacturer of hospital laboratory diagnostic instrumentation

1986-1996

Program Manager, Product Development


Built and directed 3 multi-disciplinary teams totaling 24 software, hardware and scientific professionals in the design and development of bio-sensor driven Blood Gas Electrolyte and Electrolyte Chemistry analyzers generating yearly revenues of approximately $20M Developed 22 FDA regulated medical diagnostic products designed for manufacturability in 2 major product lines Met time and cost goals for the first time in company history Conducted market research directly with customers to define new product features Demonstrated technical expertise and knowledge by diagnosing and resolving difficult field problems on new products while training Technical Services to become familiar with the products Recognized technical contributor and resource to guide team members through technical bottlenecks Selected by the Corporate Quality Committee to be the company's first Quality Team Facilitator

EARLIER CAREER PROGRESSION LION PRECISION CORPORATION, Billerica, Massachusetts


Manufacturer of automated industrial controls and measurement instrumentation

Vice President, Engineering ORION RESEARCH INCORPORATED, Cambridge, Massachusetts


Manufacturer of scientific laboratory instrumentation

Principal Engineer Reliability Manager Senior Engineer EDUCATION MBA MSEE BSEE Boston College, Chestnut Hill, Massachusetts Northeastern University, Boston, Massachusetts WPI, Worcester, Massachusetts

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