Program Manager

MethodHub; Batesville (IN); On-site; USD 150,000 - 190,000; Full time

Job summary

MethodHub is seeking an experienced leader to drive end-to-end PDE and QMS improvements in medical device product development. You will guide cross-functional teams across R&D, Quality, Regulatory, and Operations to streamline processes and ensure regulatory compliance.

The role requires 15+ years in related disciplines, deep regulatory knowledge, and a proven track record of delivering measurable improvements using Lean, Six Sigma, and AI-enabled workflows.

Qualifications

• Bachelor's degree required in a relevant field.
• 15+ years in product development, quality systems or process excellence.
• Significant medical products industry experience.
• Experience with validated systems, regulated digital tools, data governance, or AI governance.
• Lean Six Sigma certification or demonstrated mastery (preferred).
• Strong knowledge of regulatory and quality frameworks (FDA/QSR, ISO 13485).
• Ability to lead cross-functional transformations in matrixed environments.
• Proven ability to drive measurable process improvements and automation initiatives.

Responsibilities

• Lead end-to-end process improvement across PDE, QMS, and related workflows.
• Map current-state processes, identify friction points, and prioritize simplificationRoadmaps.
• Pilot and deploy AI-enabled processes with governance and controls.
• Develop procedures, training materials, and reusable patterns for sustained value.
• Partner with Quality and Regulatory leaders to ensure compliance in new designs.

Skills

Regulatory & Quality Knowledge

Medical device development

Design controls

Change control

Design history documentation

Quality system requirements

FDA QSR & ISO 13485

Process Improvement

Lean / Six Sigma

Value-stream mapping

AI governance / automation

Cross-functional leadership

Stakeholder management

Metrics & data analysis

Executive communication

Independence & accountability

Education

Bachelor's degree in engineering, science, quality, operations, business, or related field

Advanced degree (preferred)

Job description

Skills/Attributes:

Medical device, Process Improvement, Six Sigma

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