Program Manager

Program Manager
Batesville, IN, USA

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 discipline
Significant experience in the medical products industry
Experience 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 Knowledge
Deep knowledge of medical device or other regulated product development
Design controls
Change control
Design history documentation
Quality system requirements
Working knowledge of FDA Quality System requirements and ISO 13485
Process Improvement
Demonstrated success leading end-to-end process improvement across multiple functions, sites, or business units
Expertise in Lean, Six Sigma, value-stream mapping, or equivalent process optimization methods
Record of delivering measurable results
Experience leading complex, cross-functional transformation or continuous-improvement initiatives in a matrixed organization
Practical experience applying automation and AI to business or technical workflows
Preferably in a regulated environment
Ability to translate complex regulatory and process requirements into clear, efficient, and usable ways of working
Strong facilitation, change leadership, and stakeholder-management skills
Ability to influence senior leaders and subject-matter experts
Demonstrated ability to establish metrics, analyze process performance, prioritize opportunities, and communicate recommendations to leadership
Excellent written and verbal communication skills
Credible with engineers, quality professionals, regulatory partners, and auditors
High degree of independence
Accountability for results in an ambiguous, cross-functional environment
Commitment to Baxter's mission, patient safety, quality, and leadership expectations
Assess and map end-to-end PDE, QMS, and related business processes that affect R&D
Work with executing teams to establish current-state cycle time, effort, handoffs, rework, and pain points
Develop and maintain a prioritized process simplification roadmap based on business value, compliance risk, effort removed, cycle-time reduction, and stakeholder readiness
Redesign high-priority processes to eliminate unnecessary steps, redundant activities, duplicate documentation, and unclear handoffs
Preserve patient safety, product quality, and regulatory compliance
Partner with Quality and Regulatory leaders to align PDE practices, quality system requirements, local procedures, and working-level execution before piloting or deploying changes
Clarify functional ownership, decision rights, phase criteria, roles, and interfaces across shared product development processes
Identify, prioritize, and implement practical AI and automation use cases for document drafting, review, search, data preparation, traceability, and knowledge retrieval
Establish appropriate governance, human review, documentation, and controls for AI-enabled processes in regulated environments
Lead pilots, measure before-and-after performance, capture lessons learned, and refine solutions prior to broader deployment
Develop updated procedures, job aids, reusable patterns, and training materials
Enable process owners and teams to sustain improvements after the engagement
Provide clear recommendations, progress updates, risks, and decisions to R&D PMO leadership and cross-functional stakeholders
Lead change through influence, facilitate alignment across functions, and resolve competing priorities without direct authority
First 90 days: Complete a current-state map of priority PDE and QMS flows
First 90 days: Quantify the most significant friction points
First 90 days: Align stakeholders on a prioritized simplification and AI opportunity roadmap
Months 4 9: Redesign and pilot two to three processes end to end
Months 4 9: Deploy selected AI use cases with governance in place
Months 4 9: Release updated procedures, tools, and training
Months 10 12: Demonstrate measurable reductions in development cycle time, process effort, or rework
Months 10 12: Document adoption and control effectiveness
Months 10 12: Transition ownership with a sustaining plan
Core measures: Cycle time, effort removed, rework reduction, adoption, process compliance, user feedback, and sustainability of results
Reports to CCS R&D PMO leadership
Works directly with R&D, PDE, Quality, and Regulatory process owners
Engages cross-functional partners in Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, Information Technology, Data Privacy, and other functions whose processes affect product development