Manufacturing Process Leader-Medical Device, Lean & Quality

Intellectt Inc; North Haven (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

Intellectt Inc. is seeking an experienced Manufacturing Engineer to provide technical leadership in a regulated production environment.

You will design and optimize processes, validate methods, and drive CAPA, RCA, and PFMEA initiatives across cross‑functional teams. The role requires 7+ years in manufacturing engineering, a strong background in medical devices or regulated manufacturing, and proficiency in lean/Six Sigma methodologies.

Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related field.
• 7+ years of Manufacturing Engineering experience.
• Medical device or regulated manufacturing experience.
• Strong experience in process validation, RCA, CAPA, and process improvement.
• Knowledge of Lean Manufacturing, Six Sigma, PFMEA, and quality systems preferred.

Responsibilities

• Provide technical leadership and manufacturing support.
• Develop and optimize manufacturing processes.
• Support process validation, CAPA, PFMEA, and RCA.
• Drive process improvement, cost reduction, and quality initiatives.
• Investigate manufacturing issues and implement corrective actions.
• Collaborate with Quality, Production, Engineering, and Supplier Quality teams.
• Support equipment improvements and continuous improvement projects.
• Ensure compliance with quality systems and regulatory requirements.

Skills

Manufacturing leadership

Process improvement

Collaboration

Quality systems

Education

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

Tools

PFMEA

RCA

CAPA

Lean

Six Sigma

Job description

Intellectt Inc. is seeking an experienced Manufacturing Engineer to provide technical leadership in a regulated production environment.

You will design and optimize processes, validate methods, and drive CAPA, RCA, and PFMEA initiatives across cross‑functional teams. The role requires 7+ years in manufacturing engineering, a strong background in medical devices or regulated manufacturing, and proficiency in lean/Six Sigma methodologies.