Bachelor's degree in Engineering, Manufacturing, Operations, or a related field.
5+ years of experience in continuous improvement or process engineering within a regulated manufacturing environment (medical device preferred).
Strong working knowledge of Lean, Six Sigma, and structured problem-solving tools.
Experience in FDA-regulated and ISO 13485 environments.
Demonstrated success in leading continuous improvement projects and cross-functional teams.
Responsibilities
Develop and implement sitewide continuous improvement strategies aligned with business goals.
Facilitate Kaizen events, value stream mapping, and root cause analysis workshops.
Mentor and train employees on continuous improvement tools and Lean practices.
Establish systems to monitor and report continuous improvement progress and KPIs.
Analyze production and quality performance for efficiency and cost reduction.
Drive initiatives using Lean/Six Sigma methodologies like DMAIC and PDCA.
Collaborate with teams to streamline workflows and improve material flow.
Benefits
Equal Opportunity Employer status ensuring a fair hiring process.
Full Job Description
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.
About Mirion Technologies, Inc.
Mirion Technologies, Inc. is a global provider of radiation detection and measurement solutions for a variety of industries including nuclear power, medical, and homeland security. The company's products include radiation detectors, dosimeters, and spectroscopy systems. Mirion Technologies, Inc. was founded in 1958 and is headquartered in Sophia Antipolis, France. The company has a global presence with operations in North America, Europe, and Asia. Mirion Technologies, Inc. is privately held and does not disclose its financial information.
