David Winer has over 30 years of experience in product development and program management, primarily within the medical device industry. He has held director and VP roles at companies such as QIAGEN, Digene, Kronos, EMC, and Nova Biomedical, where he has led cross-functional teams in developing diagnostic instrumentation and analyzing systems. Winer also has expertise in areas like quality systems, FDA regulations, and project management methodology. Currently, he works as an independent consultant, advising clients on product development processes.

1. David Winer,PMP
DirectorVPProgram Manager withExpertise inMedical Devices,R&D
dwiner@ieee.org
GlenwoodAssociates (2010 – Present)
ProductDevelopmentProgramDirector
 Consultantprogrammanager
 Projectcoach.
 Designandexecutionof complexproductdevelopmentprojects.
 Productdevelopmentexecutiveleadership.
 Engineeringleadership.
 Projectmanagement.
 Team building.
 Requirementsmanagement.
 Qualitysystemcompliance.
QIAGEN(2006 – 2010)
Director,Program Management
 Directeda multi-milliondollarMDx instrumentationdevelopmentprogramunderFDA class3
device guidelinesassuringadherence toproductrequirements.
 Selectedthe contractdeveloperandmanufacturerandcoordinatedproductdevelopmentunder
ISO13485 medical device standard,ISO14971 riskmanagementstandard,IEC60601 safety
standards,and21 CFRPart 820 QSR.
 Engagedinclinical trial andFDA PMA submissionplanning.
 Directeddetailedsystemlevel verification,validationplanningandexecutionthusassuring
minimal failuresandrepeattests.
 Leda cross-functionalcore teamof Operations,Service,Marketing,Quality,Regulatory,and
local and remote Developmentengineersandscientists.
Digene (2006 – 2008)
Associate Director,InstrumentationPrograms
Digene acquiredbyQIAGEN 9/2007
 Repaireddysfunctionalrelationshipbetweencontractdeveloperandcustomerbyopening
communicationlinesandclarifyingrequirements.
 Leda cross-functionalcore teamof Operations,Service,Marketing,Quality,Regulatory,and
local and remote Developmentengineersandscientistsinthe developmentof anautomated
moleculardiagnosticssample preparationsystem.
Kronos, Inc (2003 – 2005)
SeniorEngineeringManager
 Managed all schedulingprojectsandreleaseengineeringwithinthe corporate suite of products.
 Leda highlyfocusedgroupof software engineersinthe developmentof aunique automated
workforce schedulingproductwithfocusonhighqualityanddelivery withinasmall window of
opportunity.Deliveredproductearly,enablingsalestoexceedgoalsinthe quarterof release.

2. EMC (1997 – 2002)
SeniorEngineeringManager
 Built2 groups of software developersandsystemsintegratorsandorganizedintoa cohesive
teamwithconcrete goals,therebyincreasingproductivity.
 Grewyearlyrevenue from$30M to $100M withnew productreleases.
 Providedstrategicdirectiontoproductdevelopmentactivitiesthatincreasedcustomers’
productacceptance.
 Managed relationshipswithinternalandexternalcustomersandsubcontractorsassuringproject
goalswere reached.
SeniorProgram Manager
 Createdcommunicationlinksbetweenisolateddevelopmentteamsresponsible for$1Billionin
sales,reducingredundancyandimprovingoverall effectivenessandtimes-to-market.
 Scheduledandcontrolledproductdevelopmentactivitiesandreportedtoexecutive
managementregularlytoimprovedecisionmakingeffectiveness.
 Developedinterdepartmental relationshipsthatremovedprocedural roadblocksallowing
software developerstofocusontheirstrengths,reducingtimes-to-market.
Nova Biomedical (1986 – 1996)
Program Manager,ProductDevelopment
 Builtanddirected3 multi-disciplinaryteamstotaling24 software,hardware andscientific
professionalsinthe designanddevelopmentof bio-sensordrivenBloodGas/Electrolyte and
Electrolyte/Chemistryanalyzersgeneratingyearlyrevenuesof approximately$20M.
 Demonstratedahighdegree of productivitybycompletingdevelopmentof 22 different
analyzersplusaccessoriesin9years.
 Conductedvoice of the customerresearchdirectlywithcustomerstodefinenew product
features.
 Demonstratedtechnical expertise andknowledgebydiagnosingandresolvingdifficultfield
problemsonnewproductswhile trainingTechnical Servicestobecome familiarwiththe
products.
 Recognizedtechnicalcontributorandresource toguide teammembersthroughtechnical
bottlenecks.
 Selectedbythe Corporate QualityCommitteetobe the company'sfirstTQM TeamFacilitator.
Lion Precision(1985 – 1986)
Vice President,Engineering/Directorof Engineering
 Focuseda groupof individual contributorswhohadbeenoperatingwithlittledirection,
acceleratingcompletionof newproductdesigns.
 Cementedstrategicdirectionby creatingandpresentinga3-yearproductdevelopmentplanto
the Board of Directors.
 Implementeddocumentationcontrol systemsforeffective control of designchanges.
 Solvedamajor customerproblembydirectingthe developmentof andinstallingacustomized
non-contactgagingsystem.

3. Certifications:
PMP, PMI,Six SigmaGreenBelt
Languages :
German
Skills:
FDA,Medical Devices,ProgramManagement,ProductDevelopment, ISO13485, QualitySystem,
R&D, Management,Hardware Diagnostics, ProjectManagement
Education :
Boston College
MBA, BusinessAdministrationandManagement,General
NortheasternUniversity
MSEE, ComputerScience
WorcesterPolytechnicInstitute
Bachelor’sDegree,ElectricalandElectronicsEngineering