Product Delivery Excellence Lead: Process Simplification & AI

Us Tech Solutions; Batesville (IN); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

US Tech Solutions seeks a Senior Consultant to lead a 12-month PDE & R&D Process Simplification engagement across CCS. You will partner with R&D, Quality and Regulatory to reduce process burden, clarify ownership and apply governed automation to improve speed, quality and compliance, while preserving patient safety.

The role involves piloting changes, establishing governance, delivering updated procedures and training materials, and guiding stakeholders through organizational change with minimal

Qualifikationen

• Bachelor’s degree in engineering, science, quality, operations, business or related field.
• Typically 15+ years of experience in product development, quality systems and process improvement in medical products.
• Lean Six Sigma certification or equivalent mastery preferred.
• Experience with validated systems, regulated digital tools, data governance or AI governance preferred.

Aufgaben

• Assess and map PDE, QMS and related processes across R&D.
• Develop a prioritized simplification roadmap based on value and risk.
• Redesign processes to remove unnecessary steps while preserving compliance.
• Align PDE with Quality and Regulatory requirements before pilots.
• Clarify ownership, roles and interfaces across product development processes.
• Identify and implement AI/automation use cases with governance.
• Establish governance, reviews and controls for AI-enabled processes.
• Lead pilots, measure performance and capture lessons learned.
• Produce updated procedures, job aids and training materials.
• Provide progress updates, risks and decisions to R&D PMO leadership.

Kenntnisse

Process improvement

Lean Six Sigma

Value-stream mapping

Automation & AI

Regulatory compliance

Stakeholder management

Change leadership

Process ownership

Ausbildung

Bachelor’s degree in engineering/science/quality/operations/business

Jobbeschreibung

US Tech Solutions seeks a Senior Consultant to lead a 12-month PDE & R&D Process Simplification engagement across CCS. You will partner with R&D, Quality and Regulatory to reduce process burden, clarify ownership and apply governed automation to improve speed, quality and compliance, while preserving patient safety.

The role involves piloting changes, establishing governance, delivering updated procedures and training materials, and guiding stakeholders through organizational change with minimal