David Winer Email & Phone Number

Rockville, Md, Us

Owings Mills, Md

In vitro diagnostic device development covering the span of hardware and assay development. Manage off shore device development and domestic assay kit development.

Washington D.C. Metro Area

Attending Networking Events Researching Industry LeadersTracking Industry TrendsParticipating in Industry Discussions

Consultant program manager. Project coach. Design and execution of complex product development projects. Product development executive leadership. Engineering leadership. Project management. Team building. Requirements management. Quality system compliance.

• 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.

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.

• 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 ·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.Senior Program Manager·Created communication links between isolated development teams responsible for $1Billion in sales, reducing redundancy and improving overall effectiveness and times-to-market.·Scheduled and controlled product development activities and reported to executive management regularly to improve decision making effectiveness.·Developed interdepartmental relationships that removed procedural roadblocks allowing software developers to focus on their strengths, reducing times-to-market.

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, EngineeringDirector 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.

Developed circuits and systems for laboratory grade scientific and clinical instruments.

Mba, Business Administration And Management, General

Msee, Computer Science

Bachelor’S Degree, Electrical And Electronics Engineering