PDE & R&D Process Optimization Leader

eTeam; Batesville (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

eTeam seeks a Sr. Program Manager to lead a 12‑month effort to simplify PDE and R&D processes, partnering with Quality, Regulatory and other functions to reduce burden, speed development, and ensure compliance.

You will redesign high-priority processes, apply AI where appropriate, establish governance for AI-enabled workflows, run pilots, and deliver updated procedures, tools and training to sustain improvements.

Qualifications

• Bachelor’s degree in engineering, science, quality, operations, or a related field.
• 15+ years of experience in product development, quality systems, operational excellence, process engineering, program management or related discipline, including medical products.
• Experience leading cross-functional transformation in a matrixed organization.
• Working knowledge of FDA Quality System requirements and ISO 13485.
• Lean Six Sigma certification or equivalent demonstrated mastery.

Responsibilities

• Assess and map end-to-end PDE, QMS and related processes to establish current-state cycle time, effort, handoffs and pain points.
• Develop and maintain a prioritized process simplification roadmap based on value, risk, effort removed and readiness.
• Redesign high-priority processes to remove steps and unclear handoffs while preserving compliance.
• Align PDE practices with Quality and Regulatory requirements before pilots or deployments.
• Clarify ownership, decision rights, roles and interfaces across product development processes.
• Identify and implement AI and automation use cases for drafting, review, search, data prep, traceability and knowledge retrieval.
• Establish governance for AI-enabled processes in regulated environments.
• Lead pilots, measure performance, capture lessons learned and refine solutions.
• Develop updated procedures, job aids, reusable patterns and training materials to sustain improvements.
• Provide clear recommendations, progress updates, risks and decisions to R&D PMO leadership.

Skills

Process improvement

Lean Six Sigma

Project management

Regulatory knowledge

AI/automation experience

Stakeholder management

Cross-functional leadership

Education

Bachelor's degree in engineering/science

Lean Six Sigma certification

Job description

eTeam seeks a Sr. Program Manager to lead a 12‑month effort to simplify PDE and R&D processes, partnering with Quality, Regulatory and other functions to reduce burden, speed development, and ensure compliance.

You will redesign high-priority processes, apply AI where appropriate, establish governance for AI-enabled workflows, run pilots, and deliver updated procedures, tools and training to sustain improvements.