• Washington DC
  • dwiner@ieee.org

David Winer

Director VP Program Manager with Expertise in Medical Devices, R&D

Work History

Work History

Product Development Program Director

2010 - Present
Glenwood Associates
Product Development Program Director

Director, Program Management

2006 - 2010
QIAGEN
Director, Program Management Directed a multi-million dollar MDx instrumentation development program under FDA class 3 device guidelines assuring adherence to product requirements. Selected the contract developer and manufacturer 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. Engaged in clinical trial and FDA PMA submission planning. Directed detailed system level verification, validation planning and execution thus assuring minimal failures and repeat tests. Led a cross-functional core team of Operations, Service, Marketing, Quality, Regulatory, and local and remote Development engineers and scientists.

Associate Director, Instrumentation

2006 - 2008
Digene
Associate Director, Instrumentation Programs Digene acquired by QIAGEN 9/2007 Repaired dysfunctional relationship between contract developer and customer by opening communication lines and clarifying requirements. Led a cross-functional core team of Operations, Service, Marketing, Quality, Regulatory, and local and remote Development engineers and scientists in the development of an automated molecular diagnostics sample preparation system.

Senior Engineering Manager

2003 - 2005
Kronos, Inc
Senior Engineering Manager 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. Delivered product early, enabling sales to exceed goals in the quarter of release.

Senior Engineering Manager

1997 - 2002
EMC
Senior Engineering Manager Built 2 groups of software developers and systems integrators and organized into a cohesive team with concrete goals, thereby increasing productivity. Grew yearly revenue from $30M to $100M with new product releases. Provided strategic direction to product development activities that increased customers' product acceptance. Managed relationships with internal and external customers and subcontractors assuring project goals were reached.

Program Manager, Product Development

1986 - 1996
Nova Biomedical
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. Demonstrated a high degree of productivity by completing development of 22 different analyzers plus accessories in 9 years. Conducted voice of the customer 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 TQM Team Facilitator.

Vice President, Engineering/director

1985 - 1986
Lion Precision
Vice President, Engineering/Director of Engineering Focused a group of individual contributors who had been operating with little direction, accelerating completion of new product designs. Cemented strategic direction by creating and presenting a 3-year product development plan to the Board of Directors. Implemented documentation control systems for effective control of design changes. Solved a major customer problem by directing the development of and installing a customized non-contact gaging system. Certifications: PMP, PMI, Six Sigma Green Belt Languages: German Skills: FDA, Medical Devices, Program Management, Product Development, ISO 13485, Quality System, R&D, Management, Hardware Diagnostics, Project Management

Education

Education

BACHELORS

Worcester Polytechnic Institute

MSEE

Northeastern University

M.B.A

Boston College