AI-Driven Process Improvement Lead – Medical Devices

Evolutyz Corp; Chesterfield (MO); Hybrid; USD 180,000 - 250,000; Full time

Benefits offered by this job

Dynamic environment

Cross-functional collaboration

Impact on patient safety and quality

Job summary

Evolutyz Corp is seeking a senior leader in medical device process improvement to map PDE and QMS workflows, drive cross-functional transformation, and implement AI-enabled automation. Hybrid workplace in the United States with extensive senior stakeholder interaction and a focus on patient safety and regulatory compliance.

The role emphasizes Lean Six Sigma, cross-functional leadership, and measurable cycle-time reductions, with a multi-year roadmap and substantial autonomy to deliver

Qualifications

• Bachelor's degree in a related field is required.
• Advanced degree is preferred.
• Typically, 15+ years of experience in product development, quality systems, operational excellence, or related discipline.

Responsibilities

• Assess and map end-to-end PDE, QMS, and related processes affecting R&D.
• Collaborate to establish current-state cycle time, effort, handoffs, rework, and pain points.
• Develop and maintain a prioritized process simplification roadmap based on business value and risk.
• Redesign high-priority processes to eliminate unnecessary steps while preserving patient safety and regulatory compliance.
• Partner with Quality and Regulatory leaders to align PDE practices and local procedures.
• Identify and implement AI and automation use cases for drafting, review, search, data prep, traceability.
• Lead pilots, measure outcomes, and refine solutions prior to broader deployment.
• Develop updated procedures, job aids, and training materials.
• Enable process owners to sustain improvements after engagement.
• Provide recommendations and updates to R&D PMO leadership and stakeholders.
• Lead change across functions and resolve competing priorities.
• First 90 days: map priority PDE and QMS flows; align stakeholders.
• Months 4–9: redesign and pilot end-to-end processes with AI governance.
• Months 10–12: demonstrate measurable reductions and transition ownership.

Skills

Regulatory Knowledge

Quality Systems

Process Improvement

Cross-functional leadership

Automation / AI in workflows

Stakeholder management

Executive communication

Independence & accountability

Education

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

Advanced degree preferred

Job description

Evolutyz Corp is seeking a senior leader in medical device process improvement to map PDE and QMS workflows, drive cross-functional transformation, and implement AI-enabled automation. Hybrid workplace in the United States with extensive senior stakeholder interaction and a focus on patient safety and regulatory compliance.

The role emphasizes Lean Six Sigma, cross-functional leadership, and measurable cycle-time reductions, with a multi-year roadmap and substantial autonomy to deliver