About this opportunity
Transcend IT Solutions lists this Process Improvement Manager – Medical Device / MedTech opportunity in batesville, Indiana. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Position Title: Program Manager
Job Location: Batesville, IN, USA
Employment Type: Temporary
Estimated Duration (In Months): 13
Work Model: Onsite
Must have Skills/Attributes: Medical device, Process Improvement, Six Sigma
RequiredEducation
Bachelor'sdegreeinengineering,science,quality,operations,business,orarelatedfield—required
PreferredEducation
Advanceddegree
RequiredExperience
Typically,15ormoreyearsofexperienceinproductdevelopment,qualitysystems,operationalexcellence,processengineering,programmanagement,orarelateddiscipline
Significantexperienceinthemedicalproductsindustry
Experiencewithvalidatedsystems,regulateddigitaltools,datagovernance,orAIgovernance
PreferredCertification
LeanSixSigmacertificationorequivalentdemonstratedmastery
RequiredSkills
Regulatory&QualityKnowledge
Deepknowledgeofmedicaldeviceorotherregulatedproductdevelopment
Designcontrols
ChangecontrolDesignhistorydocumentation
Qualitysystemrequirements
WorkingknowledgeofFDAQualitySystemrequirementsandISO13485
ProcessImprovement
Demonstratedsuccessleadingend-to-endprocessimprovementacrossmultiplefunctions,sites,orbusinessunits
ExpertiseinLean,SixSigma,value-streammapping,orequivalentprocessoptimizationmethods
Recordofdeliveringmeasurableresults
Experienceleadingcomplex,cross-functionaltransformationorcontinuous-improvementinitiativesinamatrixedorganization
PracticalexperienceapplyingautomationandAItobusinessortechnicalworkflows
Preferablyinaregulatedenvironment
Abilitytotranslatecomplexregulatoryandprocessrequirementsintoclear,efficient,andusablewaysofworking
Strongfacilitation,changeleadership,andstakeholder-managementskills
Abilitytoinfluenceseniorleadersandsubject-matterexperts
Demonstratedabilitytoestablishmetrics,analyzeprocessperformance,prioritizeopportunities,andcommunicaterecommendationstoleadership
Excellentwrittenandverbalcommunicationskills
Crediblewithengineers,qualityprofessionals,regulatorypartners,andauditors
Highdegreeofindependence
Accountabilityforresultsinanambiguous,cross-functionalenvironment
CommitmenttoBaxter'smission,patientsafety,quality,andleadershipexpectations
Assessandmapend-to-endPDE,QMS,andrelatedbusinessprocessesthataffectR&D
Workwithexecutingteamstoestablishcurrent-statecycletime,effort,handoffs,rework,andpainpoints
Developandmaintainaprioritizedprocesssimplificationroadmapbasedonbusinessvalue,compliancerisk,effortremoved,cycle-timereduction,andstakeholderreadiness
Redesignhigh-priorityprocessestoeliminateunnecessarysteps,redundantactivities,duplicatedocumentation,andunclearhandoffs
Preservepatientsafety,productquality,andregulatorycompliance
PartnerwithQualityandRegulatoryleaderstoalignPDEpractices,qualitysystemrequirements,localprocedures,andworking-levelexecutionbeforepilotingordeployingchanges
Clarifyfunctionalownership,decisionrights,phasecriteria,roles,andinterfacesacrosssharedproductdevelopmentprocesses
Identify,prioritize,andimplementpracticalAIandautomationusecasesfordocumentdrafting,review,search,datapreparation,traceability,andknowledgeretrieval
Establishappropriategovernance,humanreview,documentation,andcontrolsforAI-enabledprocessesinregulatedenvironments
Leadpilots,measurebefore-and-afterperformance,capturelessonslearned,andrefinesolutionspriortobroaderdeployment
Developupdatedprocedures,jobaids,reusablepatterns,andtrainingmaterials
Enableprocessownersandteamstosustainimprovementsaftertheengagement
Provideclearrecommendations,progressupdates,risks,anddecisionstoR&DPMOleadershipandcross-functionalstakeholders
Leadchangethroughinfluence,facilitatealignmentacrossfunctions,andresolvecompetingprioritieswithoutdirectauthority
First90days:Completeacurrent-statemapofpriorityPDEandQMSflows
First90days:Quantifythemostsignificantfrictionpoints
First90days:AlignstakeholdersonaprioritizedsimplificationandAIopportunityroadmap
Months4–9:Redesignandpilottwotothreeprocessesendtoend
Months4–9:DeployselectedAIusecaseswithgovernanceinplace
Months4–9:Releaseupdatedprocedures,tools,andtraining
Months10–12:Demonstratemeasurablereductionsindevelopmentcycletime,processeffort,orrework
Months10–12:Documentadoptionandcontroleffectiveness
Months10–12:Transitionownershipwithasustainingplan
Coremeasures:Cycletime,effortremoved,reworkreduction,adoption,processcompliance,userfeedback,andsustainabilityofresults
ReportstoCCSR&DPMOleadership
WorksdirectlywithR&D,PDE,Quality,andRegulatoryprocessowners
Engagescross-functionalpartnersinOperations,Manufacturing,SupplyChain,Marketing,Medical,Service,InformationTechnology,DataPrivacy,andotherfunctionswhoseprocessesaffectproductdevelopment
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Worksite address
batesville, IN, 47006, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.