Resume for 13+ year experienced technology developer and program leader in healthcare and life sciences and medical device design.

1. Robert Donley, P.E., MBA rob.donley@gmail.com
EXECUTIVE SUMMARY
I lead multi-functional global teams to guide technologies from R&D studies to manufactured commercial
products in highly regulated industries. Road mapping and completing the development of products through
their lifecycle has allowed my teams to have an impact of $400k to $150M in captured value. My passion is
finding creative solutions to complex problems.
TECHNICAL EXPERIENCE
 Program Management  ProductDevelopment  Manufacturing  Leadership
 RelationshipBuilding  Managing Risk  Global SupplyChain  BloodComponentTech
 VascularDevices  MolecularDiagnostics  RoboticSurgery  Tissue Biopsy/Imaging
 Regulatory/FDA  StrategicDecisionMaking  BusinessDevelopment  Single Use Disposables
 Kaizen/HoshinKanri  5S Lean Leadership  Analytics/BI  FMEA/RCA/DFX
HIGHLIGHTS
 Conceptualization&developmentof Intellectual Propertyfor five differentmedical device companies
 Programliasonbetweenexternal customer,internalprojectsupport,andactivitiesatcontractMFG
 Commercializedsix programsby leadingteamsin DFM,Reliability Enhancements,andTransition
 Proficientinall aspectsof programmanagement:budgeting, resource allocation,scheduling &execution
 Directcollaborationwithsurgeonsondeviceprototypeevolutionformultiple surgical applications
 Experiencedatleading RootCause Analysis,Corrective Actions,TestingandImplementation
 SpecialistinDesignforSupplyChainfromPrototyping toProductionSupplierValidation
 Hands onexperiencewith clinical testingonadiverse range of surgical instruments/machines
 Cost-Reduction architectforsystems indesign,achievingaverage of 40-60% decrease in COGS
 Accomplished atpreparing/presentingexecutive levelpresentationstoSr. Mgmt and Board of Directors
PROFESSIONAL EXPERIENCE
Project/Program Manager,Plexus,Boulder,CO 2016 – Present
Plexusis a Global CMOin the electronics industry, BDCwas focused on healthcare,servicing multiple clients.
Program Governance,BusinessDevelopment,ProductandProjectFinancialStrategy.MentoringGlobal
Internal andExternal Engineeringteamsindesign,productionmethod selection,supplychain,timetomarket
analysis,andtotal cost of ownership. Instart-upsandFortune 500 companies,I gainedbroadexperience in
operationsandbusinessdevelopmentinAMER,APAC,andEMEA.
 Advise clientseniorandexecutiveleadership onprogramstrategy,status,risk
 Managing transitionof $70MM mid-vol.high-complexityMFGProgramfrom cradle to grave inUS/MX
 ConsultwithclientsregardingOrganizational Change,DesigntoMFG Processes
 Mentoringteamsonskill fitandgaps,developingtrainingandstretchassignmentsto increase capability
 AchievedTestingapproval onfive systemsincompliance w/IEC60601 4th editionrequirements
 Implementedstrategicchange resultinginNetPromoterScore conversiononseveral keyaccounts
 Empoweringresource limitedteamswithflexible capabilitiestoimprove Time-to-Market
 Foundingmemberof ZeroDefectDesign,aninternalteamdedicatedtoimprovingOrganizational
Performance inEngineeringandManufacturing withAnalytics/BI
 EnhancingBusinessDevelopmentbystructuringvalue creationinclientproposals withstrategy
 Addedcapabilitiesbyleadingcapital expenditurestointegrate new technologies

2. Principal Engineer,GE Healthcare/Carefusion/BD,Centennial,CO 2014 – 2016
GE Healthcare, parentof Vital Signs Inc,an OEMthat produced arterialblood gasanalyserand anaesthesia
products,mostly disposables,employing an engineering staff of 40and manufacturing staff of 150 in an
80,000 sq.ft. injection molding and packaging facility in Centennial,CO. VSIwas acquired by BD in 2016 and
the plantwasshutdown and consolidated to a new low-costfacility in Mexicali.
Designandsustainingsupportof high-volume single use andreusableAnaesthesiaproducts,
Reprocessing/SterilizationProcedures,ECR/ECOManagement,CAPA Resolution,V&V,RCA,andRegulatory
filing.IEC60601, ISO, CDC andJCG.
 Developedretrofitnew LEDlightsource technologywithindustry-leadingperformance toregain market
share on legacyproductline
 ProductManagement;addressingcustomerfeedback,andprovidinga16% decrease inCOGS on die
stampedandultrasonicallyweldedISOgreenstandardlaryngoscope blades
 Prioritized$2.3Mincost-reductionopportunitieswithFinance team usingSAPdataanalytics
 Providedtechnical supportfortransitionof equipmenttointernational facilitiesuponfacilityclosure
 OrganizedandProducedcompany closure yearbook,celebratingthe historyof the Vital Signsplantandits
impacton the innovationanduse of arterial bloodgasanalysisinemergencymedicine
Project Manager,SeniorMechanical Engineer,Machine SolutionsInc.,Flagstaff,AZ 2011 – 2014
MachineSolutionsis an OEM Medical Device Manufacturing technology providerservicing multiple clients.
Managed engineeringprojectsinmedical devicedesignandmanufacturing.Experience withcatheter
processing,fluoroscopicmarker bandswaging,balloonpleatingandfolding,andstentcrimping.Managed
customercontact,development/change of scope andrequirements,resource planning,production,and
aftermarketservice.ReportedtoCTO/Directorsonmilestones,strategiccompatibility andnew techinR&D.
• Led Kaizen change teams to streamline engineering and operations processes with VP of Engineering
• Performed in-house customer sample product testing, serving as Application Engineer to help sales team
deliver viable solutions and field support options that met or exceeded client expectations
Mechanical Engineer I, II, Protonexand Watt Fuel Cell,Broomfield,COand NewYork, NY 2007 – 2011
Watt is a spin out company from Protonexfocusingon portablesolid oxidefuelcell powergeneration.
Designedandoperatedautomatedtestingequipmentforfuelcellcomponentsandintegratedpowergeneration
systems. Designed custom Mass Spectrometer testing equipment with multi-gas fuel cell support, and high-
temp (1000C) sampling for monitoring chemical performance of hydrocarbon reforming catalysts. Experience
with DOD/DOE projects. Built out 31,000 sq.ft. laboratory in Long Island, NY for state-of-the-art research.
Acquired and deployed former competitor assets. Filed several int’l patents on balance-of-plant design.
• Developedprototype systemsforuse infuel cell productionandlow-voltage/highcurrentelectroniccircuits
• Supported seed funding by producing technology demonstration displays with live perf. data display
• Developed new techniques and material applications supporting system optimization and reliability
EDUCATION Master of BusinessAdministration,UniversityofDenver
Bachelor of Science,Engineering,Mechanical,ColoradoSchool of Mines
PROJECT CLIENT PORTFOLIO
 Merit Medical  BostonScientific  Medtronic  GE Healthcare
 Titan Medical  EdwardsLifesciences  BayerAG  Carefusion
 Hologic,Inc.  Roche  TerumoBCT  AbbottCardiovascular