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Winer, PMP
(508) 404- 4833 dwiner@ieee.org _____________________________________________________________________________________ Rockville, MD
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.
-22011-Present
2006-2010
2003-2005
1997-2002
-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
1986-1996
Principal Engineer Reliability Manager Senior Engineer EDUCATION MBA MSEE BSEE Boston College, Chestnut Hill, Massachusetts Northeastern University, Boston, Massachusetts WPI, Worcester, Massachusetts