Senior Product Delivery Lead: R&D Process Simplification

Integrated Resources, Inc ( IRI ); Batesville (IN); On-site; USD 130,000 - 190,000; Full time

Job summary

Integrated Resources, Inc (IRI ) seeks a Senior Consultant to lead a 12-month effort to simplify end-to-end PDE and R&D processes, reduce burden, clarify ownership, and connect PDE with QMS. You will work across R&D, Quality, Regulatory and other functions, driving automation responsibly.

You will partner with engineers and leaders, design a prioritized roadmap, lead pilots, measure impact, and deliver updated procedures, tools and training to sustain improvements.

Qualifications

• Bachelor's degree in engineering or related field required.
• 15+ years in product development, quality systems or operational excellence in medical products.
• Lean Six Sigma certification preferred and experience with regulated environments.

Responsibilities

• Map PDE, QMS processes affecting R&D and document current-state metrics such as cycle time and handoffs.
• Create a prioritized roadmap for simplification and AI opportunities based on value and risk.
• Redesign high-priority processes to remove unnecessary steps while preserving patient safety and regulatory compliance.
• Align PDE practices with Quality and Regulatory requirements before pilots or deployments.
• Clarify ownership, decision rights, roles, and interfaces across shared product development processes.
• Identify and implement practical AI use cases for drafting, review, data prep, and knowledge retrieval.
• Establish governance and controls for AI-enabled processes in regulated environments.
• Lead pilots, measure before-and-after performance, capture lessons learned and refine solutions.
• Develop updated procedures, job aids, reusable patterns and training materials to sustain improvements.
• Provide progress updates, risks and decisions to R&D PMO leadership and stakeholders.

Skills

Lean Six Sigma

Process Improvement

Regulatory Compliance

Quality Systems

AI & Automation

Stakeholder Management

Project Leadership

Cross-functional Collaboration

Education

Bachelor's degree in engineering

Lean Six Sigma certification

Advanced degree preferred

Tools

Validated systems

Regulatory tools

Job description

Integrated Resources, Inc (IRI ) seeks a Senior Consultant to lead a 12-month effort to simplify end-to-end PDE and R&D processes, reduce burden, clarify ownership, and connect PDE with QMS. You will work across R&D, Quality, Regulatory and other functions, driving automation responsibly.

You will partner with engineers and leaders, design a prioritized roadmap, lead pilots, measure impact, and deliver updated procedures, tools and training to sustain improvements.