Operations Excellence Lead Lean Six Sigma (Medical Devices)

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

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.