Overview
Remote
On-site
Job Description
Job Description: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
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
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