Resume for 13+ year experienced technology developer and program leader in healthcare and life sciences, medical device design, chemical process control, and manufacturing.

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. In start-ups and Fortune 500 companies, I have broad experience in
operations and business development in AMER, APAC, and EMEA. Road mapping and completing the
developmentof products throughtheirlifecycle hasallowedmyteamstohave 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
 Mentoring  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,andactivitiesatcontract MFG
 AchievedTestingapproval on five systemsincompliance w/IEC60601 4th editionrequirements
 Commercializedsix programsby leadingteamsin DFM,Reliability Enhancements,andTransition
 Proficientinall aspectsof programmanagement:budgeting, resource allocation,scheduling &execution
 Directcollaborationwithsurgeonsondeviceprototypeevolutionformultiple surgical applications
 Experiencedatleading RootCause Analysis,Corrective Actions,TestingandImplementation
 SpecialistinDesignforSupplyChainfromPrototypingtoProductionSupplierValidation
 Hands onexperiencewith clinical testingonadiverse range of surgical instruments/machines
 Cost-Reduction architectforsystems indesign,achievingaverage of 40-60% decrease inunitcost
 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,ProductandProjectFinancial Strategy.MentoringGlobal
Internal andExternal Engineeringteamsindesign,productionmethodselection,supplychain,timetomarket
analysis,andtotal cost of ownership.
 Advise clientseniorandexecutiveleadershiponprogramstrategy,status,risk
 Managing transitionof $70MM mid-vol.high-complexityMFGProgramfrom cradle to grave inUS/MX
 ConsultwithclientsregardingOrganizational Change,DesigntoMFG Processes
 Mentoringinternal andexternal teamsonskillfitandgaps,developingtrainingandstretchassignmentsto
increase overall teamcapability
 Empoweringresource limitedteamswithflexible capabilitiestoimprove Time-to-Market
 Foundingmemberof ZeroDefectDesign,aninternalteamdedicatedtoimprovingOrganizational
Performance in EngineeringandManufacturingwithAnalytics/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 200 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
 Legacy complimentaryproductssupport;addressingcustomerfeedback,andprovidinga16% decrease in
COGS on die stampedand ultrasonicallyweldedISOgreenstandardlaryngoscopeblades
 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,Senior Mechanical Engineer,Machine SolutionsInc., Flagstaff,AZ 2011 – 2014
MachineSolutionsis an OEM Medical Device Manufacturing technology providerservicing many clients.
Managed engineeringprojectsin medical devicedesignandmanufacturing.Experience withcatheter
processing,fluoroscopicmarkerbandswaging,balloonpleatingandfolding,andstentcrimping.Managed
customercontact,development/change of scope andrequirements,resource planning,production,and
aftermarketservice.ReportedtoCTO/Directorsonmilestones,strategiccompatibilityandnew 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 EngineerI, 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 productionand low-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 2019
Bachelor of Science,Engineering,Mechanical,ColoradoSchool of Mines 2007
PROJECT CLIENT PORTFOLIO
 Merit Medical  BostonScientific  Medtronic  GE Healthcare
 Titan Medical  EdwardsLifesciences  BayerAG  Carefusion
 Hologic,Inc.  Roche  TerumoBCT  AbbottCardiovascular