Product Delivery Lead - R&D Process Simplification (Onsite)

Stefanini; Batesville, Northern (IN, KY); Hybrid; USD 124,000 - 138,000; Full time

Benefits offered by this job

Pay range: $90.00 - $100.00 per hour

Job summary

Stefanini Group in Batesville, IN is seeking a Senior Consultant to lead a 12-month initiative to simplify end-to-end PDE and R&D processes. You will collaborate across R&D, Quality, Regulatory and other functions to reduce burden while preserving patient safety and regulatory compliance.

The role involves piloting AI-enabled solutions, establishing governance, and delivering updated procedures and training to sustain improvements.

Qualifications

• Bachelor's degree in engineering, science, quality, operations, business or 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 related discipline, including significant experience in the medical products industry.
• Experience leading complex, cross-functional transformation or continuous-improvement initiatives in a matrixed organization.
• Working knowledge of FDA Quality System requirements and ISO 13485.
• Lean Six Sigma certification or equivalent demonstrated mastery preferred.
• Experience with validated systems, regulated digital tools, data governance or AI governance preferred.

Responsibilities

• Assess and map end-to-end PDE, QMS and related processes.
• Develop and maintain a prioritized process simplification roadmap.
• Redesign high-priority processes to eliminate unnecessary steps and unclear handoffs.
• Partner with Quality and Regulatory leaders to align PDE practices and requirements.
• Clarify functional ownership, decision rights, and interfaces.
• Identify and implement AI and automation use cases in regulated environments.
• Establish governance and controls for AI-enabled processes.
• Lead pilots and measure performance before broader deployment.
• Develop procedures, job aids, and training materials for sustained improvements.
• Provide updates to R&D PMO leadership and stakeholders.
• Lead change through influence and without direct authority.

Skills

Lean Six Sigma

Regulatory compliance

Change management

Cross-functional collaboration

Process optimization

AI governance

Data governance

Problem solving

Education

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

Advanced degree preferred

Job description

Stefanini Group in Batesville, IN is seeking a Senior Consultant to lead a 12-month initiative to simplify end-to-end PDE and R&D processes. You will collaborate across R&D, Quality, Regulatory and other functions to reduce burden while preserving patient safety and regulatory compliance.

The role involves piloting AI-enabled solutions, establishing governance, and delivering updated procedures and training to sustain improvements.