Mold Qualification Engineer
Lead injection mold qualification, process validation (DQ/IQ/OQ/PQ) and DoE for medical device components
Worth knowing
Why it is interesting. Own the full DQ/IQ/OQ/PQ qualification cycle for molds making critical medical device parts
Might not be for you. 10+ years injection molding experience required — not for early-career candidates
Adjacent materials role10+ years of experience in injection molding, tooling, process validation; strong knowledge of injection molding processes, mold design and tooling materials
- Seniority
- Senior
- Work
- On-site
- Type
- Full-time
- Experience
- 10+ yrs
- Industry
- Medical devices
- Role
- Process Engineering
Role details
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
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