Continuous Improvement Manager

About This Role

This role is responsible for leading and executing strategies that drive operational excellence in medical device manufacturing, focusing on improving product quality, reducing waste, and ensuring regulatory compliance. The manager will champion Lean, Six Sigma, and problem-solving methodologies while partnering with cross-functional teams.

Responsibilities

• Develop and implement sitewide continuous improvement strategies aligned with business goals
• Facilitate Kaizen events, value stream mapping, root cause analysis (RCA), and other improvement workshops
• Mentor and train employees in CI tools, Lean thinking, and structured problem-solving
• Establish systems to monitor, measure, and report CI progress and KPIs
• Analyze production and quality performance to identify opportunities for efficiency, cost reduction, and throughput improvements
• Drive initiatives using DMAIC, PDCA, 5S, standard work, and other Lean/Six Sigma methodologies
• Ensure improvement projects support compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements
• Plan, execute, and sustain medium-to-large scale CI projects, ensuring milestones are met
• Develop business cases, project charters, and ROI analyses to justify improvement initiatives
• Promote a culture of operational excellence and accountability throughout the organization

Requirements

• Bachelor’s degree in Engineering, Manufacturing, Operations, or related field
• 5+ years of experience in continuous improvement, operational excellence, or process engineering within a regulated manufacturing environment
• Strong working knowledge of Lean, Six Sigma, and structured problem-solving tools
• Experience working within FDA-regulated or ISO 13485 environments
• Demonstrated success leading CI projects and cross-functional teams
• Excellent analytical, communication, facilitation, and change-management skills

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Operations, or related field
• 5+ years of experience in continuous improvement, operational excellence, or process engineering within a regulated manufacturing environment (medical device preferred)

Nice to Have

• Experience in medical device manufacturing
• Familiarity with statistical software (Minitab, JMP, etc.)
• Experience with automation, digital manufacturing tools, or Industry 4.0 technologies

Skills

* Required skills