Medical Molding Process Engineer — GMP/ISO 13485

ENNOVI; Town of Florida (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading technology company is seeking a Molding Process Engineer to enhance injection molding processes for medical products. This role involves optimizing processes while collaborating across teams to ensure quality and compliance with regulatory standards. The ideal candidate possesses a degree in Engineering and significant experience in plastics processing, particularly within regulated environments, and is committed to driving efficiency and innovation in the production of medical devices.

Qualifications

• Minimum of 3 years of experience within a Plastics/Polymer processing.
• Experience in highly regulated environments.
• Experience with data analysis and systematic problem-solving.

Responsibilities

• Develop, validate, and optimize injection molding processes.
• Collaborate with teams to ensure process capability.
• Lead root cause analysis for defects and deviations.
• Support qualifications including IQ/OQ/PQ.
• Monitor and analyze process data for improvements.
• Train operators on best practices.

Skills

Polymer technology

Data Analysis

Root Cause Analysis

Statistical Method Application

Six Sigma Greenbelt

Insert molding

Automation in molding operations

Communication skills

Education

Bachelor's degree in mechanical, Industrial, or Plastics Engineering

Job description

A leading technology company is seeking a Molding Process Engineer to enhance injection molding processes for medical products. This role involves optimizing processes while collaborating across teams to ensure quality and compliance with regulatory standards. The ideal candidate possesses a degree in Engineering and significant experience in plastics processing, particularly within regulated environments, and is committed to driving efficiency and innovation in the production of medical devices.