Process Improvement Manager – Medical Device / MedTech

Transcend IT Solutions; Batesville (IN); Sur place; USD 95 000 - 130 000; Temps partiel

Résumé du poste

Transcend IT Solutions seeks a Program Manager to lead end-to-end medical device product development and process-improvement initiatives in a heavily regulated environment. The role emphasizes design controls, change control, data governance, and AI governance within a cross-functional setting.

Ideal candidates have 15+ years in product development or quality excellence, regulated systems experience, and strong leadership with stakeholders.

Qualifications

• Bachelor's degree in engineering, science, quality, operations, business, or related field—required.
• Advanced degree preferred.

Responsabilités

• Lead end-to-end process improvement across functions, sites, or business units.
• Translate regulatory and process requirements into clear, efficient work methods.
• Establish metrics, analyze performance, prioritize opportunities, and communicate recommendations.

Connaissances

Regulatory knowledge

Medical device dev

Design controls

Change control

Lean Six Sigma

Quality systems

Formation

Bachelor's degree in engineering/science/quality/operations/business

Advanced degree

Description du poste

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