Manufacturing Engineer

•Medical Devices J2B Global LLC North Haven, CT Job Details 1 day ago Qualifications Defect resolution root cause analysis Preventive action implementation Production deviation management Six Sigma methodology implementation Engineering process optimization Corrective and preventive actions (CAPA) Manufacturing facility experience Production validation processes Quality control problem-solving Root cause analysis Quality improvement programs in engineering Implementing lean manufacturing processes Full Job Description Manufacturing Engineer

•Medical Devices W2 North Haven, CT

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Job Summary:

We are looking for a Manufacturing Engineer with experience in medical device or regulated manufacturing. The role will focus on improving manufacturing processes, equipment, quality, and production efficiency while ensuring compliance with regulatory requirements. Responsibilities Lead manufacturing engineering activities for medical device production. Develop, improve, and optimize manufacturing processes, equipment, and workflows. Support process validation, RCA, CAPA, PFMEA, and quality improvement activities. Investigate manufacturing issues and implement corrective actions. Work closely with Quality, Production, Engineering, and Supplier Quality teams. Drive Lean Manufacturing, Six Sigma, cost reduction, and continuous improvement initiatives. Ensure manufacturing processes comply with FDA, quality systems, and regulatory requirements. Required Skills & Qualifications Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or a related field. 5-7+ years of Manufacturing Engineering experience. Required experience in medical device or regulated manufacturing. Strong experience with process validation, RCA/CAPA, and process improvement. Knowledge of Lean Manufacturing and Six Sigma. Experience with PFMEA is preferred. Refer