Manufacturing Engineer II - MedTech Lean Six Sigma

jj; Danvers (MA); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson in Danvers, MA seeks a Manufacturing Engineer II to advance cardiovascular manufacturing through Lean methods, process optimization, and data-driven problem solving. You will collaborate across teams to improve product quality and yield while ensuring regulatory compliance.

The role requires a Mechanical/Industrial Engineering background and 3+ years of manufacturing experience in medical devices or cleanrooms, plus experience with IQ/OQ/PQ and DOE.

Qualifications

• Lean, Six Sigma or continuous improvement initiatives.
• Minitab or equivalent statistical software.
• Ability to analyze statistical parameters leading to quantifiable solutions.
• Knowledge of FDA, QSR and ISO regulations.
• Proficiency with Microsoft Office; SAP experience preferred.

Responsibilities

• Control manufacturing processes while reducing defects and enhancing productivity and product quality.
• Use Lean and Six Sigma tools to analyze process trend data and communicate issues using a data-driven approach.
• Identify opportunities for process and yield improvement projects.
• Anticipate potential issues before they arise by relying on prior experience and new industry knowledge.
• Qualify and optimize processes and tooling via IQ/OQ/PQ, GageR&R studies, process capability studies, and DOE.

Skills

Lean

Six Sigma

Data analysis

FDA/QSR/ISO compliance

Education

Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or related

Tools

Minitab

Microsoft Office

SAP

Job description

Johnson & Johnson in Danvers, MA seeks a Manufacturing Engineer II to advance cardiovascular manufacturing through Lean methods, process optimization, and data-driven problem solving. You will collaborate across teams to improve product quality and yield while ensuring regulatory compliance.

The role requires a Mechanical/Industrial Engineering background and 3+ years of manufacturing experience in medical devices or cleanrooms, plus experience with IQ/OQ/PQ and DOE.