R&D Process Excellence Lead — Product Delivery

Cube Hub Inc.; Batesville (IN); On-site; USD 140,000 - 190,000; Full time

Job summary

Cube Hub Inc. seeks a Senior Consultant, PDE & R&D Process Simplification to lead a 12-month initiative across CCS, simplifying end-to-end product development processes while reducing burden and improving speed, quality and regulatory compliance.

You will partner with R&D, Quality, Regulatory and other functions to drive governance and AI-enabled improvements with measurable impact. This high-visibility role requires credibility with engineers, process owners, auditors and senior leaders,

Qualifications

• Bachelor’s degree in engineering, science, quality, operations, business or related field.
• Typically 15+ years of experience in product development, quality systems, operational excellence, process engineering or program management.
• Lean Six Sigma certification or equivalent mastery preferred.
• Experience in regulated medical products and quality/regulatory expectations (FDA QSR, ISO 13485).
• Experience leading cross-functional transformation in matrixed organizations.

Responsibilities

• Map and optimize PDE, QMS, and related processes across R&D.
• Develop a prioritized PDE simplification and AI opportunity roadmap.
• Redesign high-priority processes to remove steps and clarify ownership.
• Align PDE practices with Quality and Regulatory requirements before pilots.
• Clarify ownership, decision rights, roles, and interfaces across processes.
• Identify and implement AI/automation opportunities with governance.
• Establish governance and controls for AI-enabled processes in regulated environments.
• Lead pilots, measure outcomes, and capture lessons learned.
• Develop updated procedures, job aids, patterns and training materials.
• Provide progress updates and risk/decision reporting to R&D PMO leadership.

Skills

Process improvement

Lean Six Sigma

Stakeholder management

Change leadership

Regulatory knowledge

Cross-functional leadership

Communication

Project governance

AI governance

Facilitation

Education

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

15+ years in product development/quality systems

Lean Six Sigma certification

Job description

Cube Hub Inc. seeks a Senior Consultant, PDE & R&D Process Simplification to lead a 12-month initiative across CCS, simplifying end-to-end product development processes while reducing burden and improving speed, quality and regulatory compliance.

You will partner with R&D, Quality, Regulatory and other functions to drive governance and AI-enabled improvements with measurable impact. This high-visibility role requires credibility with engineers, process owners, auditors and senior leaders,