Continuous Improvement Manager

Phase2 Technology; Norfolk (VA); On-site; USD 100,000 - 140,000; Full time

Job summary

Phase2 Technology in Norfolk, VA is seeking a Continuous Improvement Manager to lead Lean/Six Sigma initiatives across our medical device manufacturing operations, driving quality, waste reduction, and cost efficiency.

You will partner with Manufacturing, Quality, Engineering, Supply Chain and Regulatory Affairs to standardize processes, champion Kaizen events, RCA, DMAIC, and a culture of continuous improvement.

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.

Responsibilities

• Develop and implement sitewide continuous improvement strategies aligned with business goals.
• Facilitate Kaizen events, value stream mapping, 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 Lean/Six Sigma methodologies.
• Collaborate with cross-functional teams to streamline workflows and improve material flow.
• Ensure improvement projects support FDA/ISO13485 compliance and risk mitigation.
• Plan, execute, and sustain medium-to-large CI projects with ROI analyses.
• Present CI updates and recommendations to senior leadership.

Skills

Lean thinking

Structured problem-solving

Change management

Cross-functional collaboration

Analytical skills

Project management

Communication skills

Facilitation

Education

Bachelor's degree in Engineering/Manufacturing/Operations

Tools

Minitab

JMP

Job description

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 problemsolving 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 mediumtolarge 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 changemanagement skills.
• Familiarity with statistical software (Minitab, JMP, etc.).
• Experience with automation, digital manufacturing tools, or Industry 4.0 technologies.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.