Operational Excellence Lead Lean Six Sigma (Medical Device)

Phase2 Technology; Florham Park (NJ); On-site; USD 100,000 - 150,000; Full time

Job summary

Phase2 Technology seeks a Continuous Improvement Manager to lead sitewide CI initiatives in a medical device manufacturing setting. You will champion Lean, Six Sigma, and problem-solving methodologies to improve product quality, reduce waste, and drive cost efficiency while ensuring regulatory compliance.

You will partner with Manufacturing, Quality, Engineering, and Regulatory Affairs to standardize processes, mentor teams, and execute projects with clear ROI, adopting DMAIC/PDCA, 5S, and

Qualifications

• Bachelor's degree required in Engineering, Manufacturing, Operations or related field.
• 5+ years in continuous improvement or process engineering within regulated manufacturing (medical device preferred).
• Strong knowledge of Lean, Six Sigma and structured problem-solving tools.
• Experience in FDA-regulated or ISO 13485 environments.

Responsibilities

• Develop and implement sitewide continuous improvement strategies aligned with business goals.
• Lead Kaizen events, value stream mapping, RCA, and other improvement workshops.
• Mentor and train employees in CI tools and Lean thinking.
• Establish systems to monitor CI progress and KPIs.
• Plan, execute, and sustain medium-to-large CI projects with ROI analyses.

Skills

Lean

Six Sigma

Problem-solving

Kaizen

DMAIC/PDCA

5S

Cross-functional leadership

Regulatory compliance

Education

Bachelor's degree in Engineering/Manufacturing/Operations

Tools

Minitab

JMP

Job description

Phase2 Technology seeks a Continuous Improvement Manager to lead sitewide CI initiatives in a medical device manufacturing setting. You will champion Lean, Six Sigma, and problem-solving methodologies to improve product quality, reduce waste, and drive cost efficiency while ensuring regulatory compliance.

You will partner with Manufacturing, Quality, Engineering, and Regulatory Affairs to standardize processes, mentor teams, and execute projects with clear ROI, adopting DMAIC/PDCA, 5S, and