R&D Process Excellence Lead — AI-Driven Process Improvement

Spectraforce; Batesville (IN); On-site; USD 120,000 - 160,000; Full time

Job summary

Spectraforce is seeking a Senior Consultant for R&D Process Excellence to lead a 12-month onsite engagement focused on simplifying end-to-end product development processes. You will collaborate with R&D, Quality, Regulatory and other functions to reduce burden, clarify ownership, and apply governance for AI-enabled improvements while maintaining compliance and patient safety.

The role requires extensive experience in regulated product development, Lean Six Sigma and change leadership, with the

Qualifications

• Deep knowledge of medical device or regulated product development incl. design controls and QMS.
• Demonstrated success leading end-to-end process improvement across functions/sites.
• Expertise in Lean, Six Sigma, value-stream mapping or equivalent.
• Experience applying automation/AI to workflows in regulated environments.
• Ability to translate regulatory requirements into clear, efficient ways of working.
• Strong facilitation and stakeholder-management skills with leaders and SMEs.
• Ability to establish metrics, analyze performance and communicate recommendations.
• Excellent written and verbal communication; credibility with engineers and QA.
• Independence, sound judgement and accountability in cross-functional settings.
• Experience in medical products industry and matrixed organizations.

Responsibilities

• Assess and map end-to-end PDE, QMS and related processes across R&D.
• Develop and maintain a prioritized roadmap for process simplification.
• Redesign high-priority processes, preserving patient safety and regulatory compliance.
• Align PDE practices with quality system requirements before changes.
• Clarify ownership, decision rights, roles and interfaces across processes.
• Identify and implement AI/automation use cases for drafting, review and data prep.
• Establish governance and controls for AI-enabled processes in regulated environments.
• Lead pilots, measure performance, capture lessons, and refine solutions.
• Develop updated procedures, job aids and training for sustainment.
• Provide progress updates, risks and decisions to R&D PMO leadership.

Skills

Lean Six Sigma

Process improvement

R&D processes

AI governance

Regulatory compliance

Education

Bachelor's in engineering/science

Advanced degree preferred

Tools

QMS systems

Job description

Spectraforce is seeking a Senior Consultant for R&D Process Excellence to lead a 12-month onsite engagement focused on simplifying end-to-end product development processes. You will collaborate with R&D, Quality, Regulatory and other functions to reduce burden, clarify ownership, and apply governance for AI-enabled improvements while maintaining compliance and patient safety.

The role requires extensive experience in regulated product development, Lean Six Sigma and change leadership, with the