Mold Qualification Engineer

The mold qualification or injection molding engineering role focuses on leading new mold development, process validation, and tooling qualification activities for critical medical device components

• 10+ years of experience in injection molding, tooling, process validation or manufacturing engineering.
• Experience with mold qualification and process validation methodologies.
• Strong knowledge of injection molding processes, mold design and tooling materials.
• Develop and execute mold qualification plans, including DQ, IQ, OQ and PQ
• Lead injection mold trails, process development and qualification activities
• Review mold designs, drawings, specifications and engineering requirements
• Establish molding process parameters
• Conduct DoE and process capabilities studies to optimize the molding process
• Evaluate dimensional, cosmetic, mechanical & functional characteristics of molded components
• Prepare and execute validation protocols and report in compliance with Quality system requirements
• Collaborate with internal stakeholders to ensure compliance