The Continuous Improvement Manager is responsible for leading, developing, and executing strategies to drive operational excellence across the medical device manufacturing organization. This role champions Lean, Six Sigma, and problem-solving methodologies to improve product quality, reduce waste, enhance cost efficiency, and ensure regulatory compliance. The Continuous Improvement Manager partners closely with Manufacturing, Quality, Engineering, Supply Chain, and Regulatory Affairs to standardize processes and cultivate a culture of continuous improvement.
Key Responsibilities
• Continuous Improvement Leadership 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 at all levels in CI tools, Lean thinking, and structured problem-solving. Establish systems to monitor, measure, and report CI progress and KPIs.
• Process Optimization & Waste Reduction 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. Collaborate with cross-functional teams to streamline workflows, enhance equipment utilization, and improve material flow.
• Quality & Regulatory Compliance Ensure improvement projects support and strengthen compliance with FDA regulations (21 CFR Part 820), ISO 13485, and internal QMS requirements. Partner with Quality teams to reduce defect rates, CAPA recurrence, and manufacturing variation. Use data-driven approaches to ensure process capability, validation support, and risk mitigation.
• Project Management 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. Present CI updates, outcomes, and recommendations to senior leadership.
• Culture & Capability Building Promote a culture of operational excellence and accountability throughout the organization. Create and maintain training materials, SOPs, and standardized processes. Coach teams to identify waste, solve problems autonomously, and embrace continuous learning.
Required 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). 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. Familiarity with statistical software (Minitab, JMP, etc.). Experience with automation, digital manufacturing tools, or Industry 4.0 technologies.