Program Manager with Medical Products Industry

Summary: Location: Batesville, IN, USA Duration: 12 Months Work Arrangement: Hybrid Key Areas: Medical device, Process Improvement, Six Sigma Responsibilities: Assess and map end-to-end PDE, QMS, and related business processes affecting R&D. Collaborate with 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 while preserving 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. Identify, prioritize, and implement practical AI and automation use cases for document drafting, review, search, data preparation, traceability, and knowledge retrieval. 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, quantify the most significant friction points, and align stakeholders on a prioritized simplification and AI opportunity roadmap. Months 4–9: Redesign and pilot two to three processes end to end, deploy selected AI use cases with governance in place, and release updated procedures, tools, and training. Months 10–12: Demonstrate measurable reductions in development cycle time, process effort, or rework, document adoption and control effectiveness, and transition ownership with a sustaining plan. Core measures: Cycle time, effort removed, rework reduction, adoption, process compliance, user feedback, and sustainability of results. Requirements: Bachelor's degree in engineering, science, quality, operations, business, or a related field — required. Advanced degree preferred. 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. 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 and accountability for results in an ambiguous, cross-functional environment. Commitment to Baxter's mission, patient safety, quality, and leadership expectations. Preferred Skills: Lean Six Sigma certification or equivalent demonstrated mastery. Benefits: Opportunity to work in a dynamic and innovative environment. Engage with cross-functional partners in Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, Information Technology, Data Privacy, and other functions affecting product development. Contribute to initiatives that enhance patient safety, product quality, and regulatory compliance.