Mold Qualification Engineer

HCL Technologies Limited; Minneapolis (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

HCL Technologies Limited seeks an experienced mold qualification and injection molding engineer to lead new mold development, process validation, and tooling qualification for critical medical device components. You will drive mold qualification plans, DoE studies, and validation protocols, collaborating with internal stakeholders to ensure compliance with Quality systems.

Ideal candidates have 10+ years in molding, tooling, or manufacturing engineering, with strong knowledge of mold design,

Qualifications

• 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 trials, process development and qualification activities.
• Review mold designs, drawings, specifications and engineering requirements.
• 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.

Responsibilities

• Lead new mold development, process validation and tooling qualification activities for critical medical device components.
• Coordinate mold qualification plans and validation activities (DQ, IQ, OQ, PQ).
• Review designs and drawings to ensure compliance with engineering requirements.
• Conduct DoE and process capability studies to optimize molding performance.
• Evaluate dimensional and functional characteristics of molded parts; document results.

Skills

Injection molding

Tooling

Process validation

Manufacturing engineering

Mold qualification

Job description

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
• 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