Senior Mold Qualification Engineer for Medical Devices

Crosslinked; Minneapolis (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

HCLTech in Minneapolis, MN seeks a Senior Mold Qualification Engineer to lead injection mold qualification, process validation (DQ/IQ/OQ/PQ) and DoE for critical medical device components.

The role emphasizes owning the full qualification cycle, developing and executing mold qualification plans, leading injection mold trails and process development, and ensuring compliance with quality system requirements while collaborating with internal stakeholders.

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
• 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

Responsibilities

• Lead mold development, qualification, and tooling qualification activities for medical device components.
• Drive DQ/IQ/OQ/PQ qualification cycles for molds.
• Lead injection mold trails and process development.
• Review designs, drawings and requirements for molding qualification.

Job description

HCLTech in Minneapolis, MN seeks a Senior Mold Qualification Engineer to lead injection mold qualification, process validation (DQ/IQ/OQ/PQ) and DoE for critical medical device components.

The role emphasizes owning the full qualification cycle, developing and executing mold qualification plans, leading injection mold trails and process development, and ensuring compliance with quality system requirements while collaborating with internal stakeholders.