Program Manager

Job Title: Program Manager Location: Batesville, IN, USA Experience: 15+ years Rate: $50/hr This is for a Senior Director - R&D Process Excellence / Product Development Transformation Lead / Quality Systems & Operational Excellence role at (Medical Devices). It needs a bachelor's in engineering/science/quality/business (Advanced degree preferred) with 15+ years in product development, QMS, process engineering, program management, significant medical device industry experience, validated systems & AI/data governance, with Lean Six Sigma preferred. You must have deep expertise in FDA QSR, ISO 13485, design controls, change control, DHF, QMS, plus proven Lean/Six Sigma/value-stream mapping driving end-to-end cross-functional process improvement with measurable results in a matrixed org. Core work is to assess & map end-to-end PDE/QMS/R&D processes, quantify cycle time/effort/handoffs/rework/pain points, and create a prioritized simplification & AI/automation roadmap based on business value, compliance risk & readiness. You will redesign high-priority processes to eliminate redundant steps/duplicate docs/unclear handoffs, clarify ownership/decision rights/phase criteria, align with Quality/Regulatory leaders, and preserve patient safety & compliance. *Required Education* Bachelor's degree in engineering, science, quality, operations, business, or a related field — required *Preferred Education* Advanced degree *Required Experience* Typically, 15 or more years of experience in product development, quality systems, operational excellence, process engineering, program management, or a related disciplineSignificant experience in the medical products industryExperience with validated systems, regulated digital tools, data governance, or AI governance *Preferred Certification* Lean Six Sigma certification or equivalent demonstrated mastery *Required Skills* Regulatory & Quality KnowledgeDeep knowledge of medical device or other regulated product developmentDesign controlsChange controlDesign history documentationQuality system requirementsWorking knowledge of FDA Quality System requirements and ISO 13485Process ImprovementDemonstrated success leading end-to-end process improvement across multiple functions, sites, or business unitsExpertise in Lean, Six Sigma, value-stream mapping, or equivalent process optimization methodsRecord of delivering measurable resultsExperience leading complex, cross-functional transformation or continuous-improvement initiatives in a matrixed organizationPractical experience applying automation and AI to business or technical workflowsPreferably in a regulated environmentAbility to translate complex regulatory and process requirements into clear, efficient, and usable ways of workingStrong facilitation, change leadership, and stakeholder-management skillsAbility to influence senior leaders and subject-matter expertsDemonstrated ability to establish metrics, analyze process performance, prioritize opportunities, and communicate recommendations to leadershipExcellent written and verbal communication skillsCredible with engineers, quality professionals, regulatory partners, and auditorsHigh degree of independenceAccountability for results in an ambiguous, cross-functional environmentCommitment to Baxter's mission, patient safety, quality, and leadership expectationsAssess and map end-to-end PDE, QMS, and related business processes that affect R&DWork with executing teams to establish current-state cycle time, effort, handoffs, rework, and pain pointsDevelop and maintain a prioritized process simplification roadmap based on business value, compliance risk, effort removed, cycle-time reduction, and stakeholder readinessRedesign high-priority processes to eliminate unnecessary steps, redundant activities, duplicate documentation, and unclear handoffsPreserve patient safety, product quality, and regulatory compliancePartner with Quality and Regulatory leaders to align PDE practices, quality system requirements, local procedures, and working-level execution before piloting or deploying changesClarify functional ownership, decision rights, phase criteria, roles, and interfaces across shared product development processesIdentify, prioritize, and implement practical AI and automation use cases for document drafting, review, search, data preparation, traceability, and knowledge retrievalEstablish appropriate governance, human review, documentation, and controls for AI-enabled processes in regulated environmentsLead pilots, measure before-and-after performance, capture lessons learned, and refine solutions prior to broader deploymentDevelop updated procedures, job aids, reusable patterns, and training materialsEnable process owners and teams to sustain improvements after the engagementProvide clear recommendations, progress updates, risks, and decisions to R&D PMO leadership and cross-functional stakeholdersLead change through influence, facilitate alignment across functions, and resolve competing priorities without direct authorityFirst 90 days: Complete a current-state map of priority PDE and QMS flowsFirst 90 days: Quantify the most significant friction pointsFirst 90 days: Align stakeholders on a prioritized simplification and AI opportunity roadmapMonths 4–9: Redesign and pilot two to three processes end to endMonths 4–9: Deploy selected AI use cases with governance in placeMonths 4–9: Release updated procedures, tools, and trainingMonths 10–12: Demonstrate measurable reductions in development cycle time, process effort, or reworkMonths 10–12: Document adoption and control effectivenessMonths 10–12: Transition ownership with a sustaining planCore measures: Cycle time, effort removed, rework reduction, adoption, process compliance, user feedback, and sustainability of resultsReports to CCS R&D PMO leadershipWorks directly with R&D, PDE, Quality, and Regulatory process ownersEngages cross-functional partners in Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, Information Technology, Data Privacy, and other functions whose processes affect product development.