What are the responsibilities and job description for the Program Manager with Medical Products Industry position at Evolutyz Corp?
Summary:
Location: Batesville, IN, USA
Duration: 12 Months
Work Arrangement: Hybrid
Key Areas: Medical device, Process Improvement, Six Sigma
Responsibilities:
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.
- 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.
- 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.
- Lean Six Sigma certification or equivalent demonstrated mastery.
- 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.