Senior Director – R&D Process Excellence / Product Development Transformation Lead

RibbitZ LLC; Batesville (IN); On-site; USD 180,000 - 240,000; Full time

Job summary

RibbitZ LLC in the United States seeks a senior transformation leader to drive cross-functional redesign of R&D, PDE, and QMS processes for medical devices. You will define AI-enabled roadmaps and metrics to accelerate development timelines while ensuring regulatory compliance.

You will partner with R&D, Quality, Regulatory, Engineering, Manufacturing, and IT leadership to deliver measurable business outcomes through change management, governance, and data-driven decisions.

Qualifications

• 15+ years of experience in Product Development, R&D, Quality Systems, Process Engineering, Operational Excellence, or Program Management.
• Significant experience within the Medical Device / Medical Technology industry.
• Strong expertise in FDA QSR, ISO 13485, Design Controls, DHF, Change Control, and QMS.

Responsibilities

• Lead end-to-end assessment and optimization of R&D, PDE, and QMS processes.
• Identify opportunities to reduce development cycle times, eliminate redundant workflows, and improve operational efficiency.
• Develop and execute process simplification, continuous improvement, and AI/automation roadmaps.
• Ensure compliance with FDA QSR, ISO 13485, Design Controls, Change Control, and DHF requirements.
• Implement AI-driven solutions for documentation, traceability, knowledge management, and workflow automation.
• Partner with R&D, Quality, Regulatory, Engineering, Manufacturing, and IT leadership to drive cross-functional transformation.
• Establish measurable KPIs to track process efficiency, compliance, adoption, and continuous improvement.

Skills

Medical device regulatory expertise

R&D process excellence

Product development

Quality Management Systems (QMS)

FDA regulations

ISO 13485

Lean Six Sigma

Digital transformation

AI/Automation roadmap

Change management

Value stream mapping

Process optimization

Data governance

AI governance

Education

Bachelor's degree in Engineering/Science/Quality/Operations/Business

Tools

AI platforms

Job description

The ideal candidate will bring extensive experience in Medical Device R&D, Product Development, Quality Management Systems (QMS), FDA Regulations, ISO 13485, Lean Six Sigma, and Digital Transformation.

Key Responsibilities

The ideal candidate will bring extensive experience in Medical Device R&D, Product Development, Quality Management Systems (QMS), FDA Regulations, ISO 13485, Lean Six Sigma, and Digital Transformation.

Key Responsibilities

• Lead end-to-end assessment and optimization of R&D, Product Development Engineering (PDE), and QMS processes.


• Identify opportunities to reduce development cycle times, eliminate redundant workflows, and improve operational efficiency.


• Develop and execute process simplification, continuous improvement, and AI/automation roadmaps.


• Ensure compliance with FDA QSR, ISO 13485, Design Controls, Change Control, and Design History File (DHF) requirements.


• Implement AI-driven solutions for documentation, traceability, knowledge management, and workflow automation.


• Partner with R&D, Quality, Regulatory, Engineering, Manufacturing, and IT leadership to drive cross-functional transformation.


• Establish measurable KPIs to track process efficiency, compliance, adoption, and continuous improvement.

Required Qualifications

• 15+ years of experience in Product Development, R&D, Quality Systems, Process Engineering, Operational Excellence, or Program Management.


• Significant experience within the Medical Device / Medical Technology industry.


• Strong expertise in FDA QSR, ISO 13485, Design Controls, DHF, Change Control, and QMS.


• Proven experience leading enterprise-wide process transformation and continuous improvement initiatives.


• Hands-on expertise in Lean Six Sigma, Value Stream Mapping, Process Optimization, and Change Management.


• Experience with AI/Automation, Validated Systems, Data Governance, and AI Governance in regulated environments.


• Strong stakeholder management, executive communication, and cross-functional leadership skills.


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

Preferred: Advanced degree and Lean Six Sigma certification.

Ideal Candidate

• A senior transformation leader who combines deep medical device regulatory expertise, R&D process excellence, operational transformation, and AI-enabled workflow optimization, with a proven record of delivering measurable business outcomes.