Manufacturing Engineer II - Lean Medical Devices

Johnson & Johnson Innovation; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson in Danvers, MA is hiring a Manufacturing Engineer II to help drive process improvements in Cardiovascular manufacturing. The role focuses on reducing defects, improving yield, and applying Lean and Six Sigma to data-driven decisions.

The ideal candidate has a Bachelor’s in Mechanical or Industrial Engineering with 3+ years of experience in medical devices or cleanrooms, plus knowledge of FDA/QSR/ISO regulations and MS Office.

Qualifications

• Lean Manufacturing and Six Sigma knowledge required.
• Bachelor’s degree in Mechanical or Industrial Engineering or related field.
• 3+ years of manufacturing experience, preferably in medical device or cleanroom environments.
• Familiarity with FDA/QSR/ISO regulations and MS Office tools.

Responsibilities

• Control manufacturing processes while reducing defects and enhancing productivity and product quality.
• Use Lean and Six Sigma to analyze data and communicate issues with a data-driven approach.
• Identify opportunities for process and yield improvements.
• Qualify and optimize processes and tooling via IQ/OQ/PQ, Gage R&R studies, and DOE.
• Collaborate with peers to improve technical skills and system knowledge.
• Develop and maintain process documentation (BOMs, routers, procedures, etc.).
• Investigate non-conforming product and implement corrective actions.
• Conduct root cause investigations using data and testing methodologies.

Skills

Lean Manufacturing

Six Sigma

Statistical analysis

FDA compliance

ISO compliance

Microsoft Excel

Education

Bachelor’s degree in Mechanical or Industrial Engineering

Advanced degree a plus

Tools

Minitab

SAP

Job description

Johnson & Johnson in Danvers, MA is hiring a Manufacturing Engineer II to help drive process improvements in Cardiovascular manufacturing. The role focuses on reducing defects, improving yield, and applying Lean and Six Sigma to data-driven decisions.

The ideal candidate has a Bachelor’s in Mechanical or Industrial Engineering with 3+ years of experience in medical devices or cleanrooms, plus knowledge of FDA/QSR/ISO regulations and MS Office.