Program Manager- Senior R&D Process Excellence & AI Transformation Lead

Job Title: Program Manager- Senior R&D Process Excellence & AI Transformation Lead
Experience: 15+ Years
Work Location: Batesville, IN
Work Auth: All Visas accepted (No H1 and No Fake Profiles)
Employment Type: Contract

Job Summary

We are seeking a highly experienced R&D Process Excellence and Transformation Leader with a strong background in medical device/product development, Quality Management Systems (QMS), process engineering, operational excellence, regulatory compliance, and AI-enabled process automation.

The ideal candidate will have extensive experience leading enterprise-wide process improvement initiatives within regulated medical product environments and will partner closely with R&D, Product Development Engineering (PDE), Quality, Regulatory, Operations, Manufacturing, Supply Chain, IT, Data Privacy, and other business functions.

This role will focus on simplifying and modernizing product development and quality processes while maintaining patient safety, product quality, regulatory compliance, and appropriate AI governance.

Required Experience

15+ years of experience in product development, quality systems, operational excellence, process engineering, program management, or a related discipline.

Significant experience within the medical device, medical products, healthcare products, or other highly regulated industries.

Strong experience with R&D product development processes, PDE, QMS, Design Controls, Change Control, and Design History Files/Documentation.

Experience with validated systems, regulated digital tools, data governance, and/or AI governance.

Demonstrated experience leading large-scale, cross-functional transformation and continuous improvement programs across multiple functions, sites, or business units.

Experience applying AI and automation to regulated business or technical workflows.

Required Skills

Medical Device & Regulatory Compliance

Deep understanding of regulated medical product development.

Strong knowledge of Design Controls, Change Control, Design History Documentation, and Quality System requirements.

Working knowledge of FDA Quality System requirements and ISO 13485.

Ability to translate complex regulatory and quality requirements into practical and efficient business processes.

Process Excellence & Continuous Improvement

Expertise in Lean, Six Sigma, Value Stream Mapping, process optimization, and continuous improvement.

Proven ability to assess and redesign end-to-end processes.

Strong experience identifying process bottlenecks, handoffs, rework, duplication, and unnecessary documentation.

Demonstrated success delivering measurable improvements in cycle time, effort reduction, rework, quality, adoption, and compliance.

Experience defining process KPIs and establishing baseline and post-implementation performance measures.

AI, Automation & Digital Transformation

Practical experience identifying and implementing AI and automation use cases within business or technical workflows.

Experience applying AI to areas such as:

Document drafting and review

Knowledge search and retrieval

Data preparation

Traceability

Process automation

Regulatory and quality documentation

Experience establishing appropriate AI governance, human review, documentation, validation, controls, and oversight in regulated environments.

Familiarity with validated digital systems and data governance requirements.

Leadership & Stakeholder Management

Strong cross-functional leadership and facilitation skills.

Ability to influence senior leaders, subject-matter experts, engineers, Quality, Regulatory, and operational teams without direct authority.

Experience resolving competing priorities in complex matrix organizations.

Strong change-management and organizational transformation capabilities.

Excellent written, verbal, presentation, and executive communication skills.

Ability to work independently and deliver results in ambiguous environments.

Key Responsibilities

Assess and map end-to-end Product Development Engineering (PDE), Quality Management System (QMS), and related R&D business processes.

Establish current-state metrics including cycle time, effort, handoffs, rework, delays, and process pain points.

Develop and maintain a prioritized process simplification and transformation roadmap.

Prioritize opportunities based on business value, compliance risk, effort reduction, cycle-time improvement, and stakeholder readiness.

Redesign high-priority workflows to eliminate unnecessary steps, redundant activities, duplicate documentation, and unclear ownership.

Ensure all improvements continue to protect patient safety, product quality, and regulatory compliance.

Partner with Quality and Regulatory leaders to align product development practices, QMS requirements, procedures, and execution models.

Clarify process ownership, decision rights, roles, interfaces, and phase-gate criteria.

Identify and implement practical AI and automation opportunities across product development and quality workflows.

Establish governance and controls for AI-enabled processes in regulated environments.

Lead process and technology pilots and measure before-and-after performance.

Capture lessons learned and refine solutions prior to enterprise deployment.

Develop updated procedures, job aids, templates, reusable process patterns, and training materials.

Enable process owners and business teams to sustain improvements after implementation.

Provide clear status updates, recommendations, risks, decisions, and performance metrics to R&D PMO leadership.

Facilitate alignment across R&D, Quality, Regulatory, Operations, Manufacturing, Supply Chain, Marketing, Medical, Service, IT, and Data Privacy teams.

First 90 Days

Complete current-state mapping of priority PDE and QMS processes.

Quantify major friction points, process delays, rework, and inefficiencies.

Establish baseline performance metrics.

Align key stakeholders on a prioritized process simplification and AI opportunity roadmap.

Months 4 9

Redesign and pilot 2 3 priority processes end-to-end.

Deploy selected AI and automation use cases with appropriate governance and controls.

Implement updated procedures, tools, job aids, and training materials.

Measure pilot effectiveness and refine solutions before broader rollout.

Months 10 12

Demonstrate measurable reductions in development cycle time, process effort, and/or rework.

Measure adoption, compliance, user feedback, and control effectiveness.

Document lessons learned and sustainability metrics.

Transition ownership to appropriate process owners with a long-term sustaining plan.

Key Success Metrics

Cycle-time reduction

Process effort removed

Rework reduction

Process adoption

Regulatory and QMS compliance

User satisfaction and feedback

AI/automation effectiveness

Sustainability of implemented improvements

Education

Required:
Bachelor's degree in Engineering, Science, Quality, Operations, Business, or a related field.

Preferred:
Advanced degree such as a Master's degree, MBA, or equivalent.

Preferred Certification

Lean Six Sigma certification or equivalent demonstrated expertise in continuous improvement and process optimization.