Molding Engineer Intern – 6‑Month Internship
Viant Medical · Heredia
Job description
About the role
This 6‑month internship supports the injection molding and sales area of a global medical‑device service provider. You will work on‑site in Heredia, Costa Rica, providing technical assistance for new product development, process validation and quality improvement.
Key responsibilities
- Assist in planning, developing and coordinating new molding activities and changes to existing processes.
- Prepare validation protocols, reports, work instructions and other documentation required for manufacturing.
- Support qualification and validation (IQ, OQ, PQ) of new products, processes, and transfers in accordance with FDA regulations.
- Develop equipment, mold and material specifications to ensure economical and reliable injection molding.
- Contribute to cost estimation and timing for capital equipment procurement.
- Initiate and maintain Device History Records.
- Troubleshoot existing molding processes to resolve quality issues.
- Analyze manufacturing processes, recommend and implement improvements, including custom fixtures and documentation.
- Train molding and quality‑assurance personnel on proper use of fixtures and processes.
Required profile
- Senior engineering student (B.S. or related) with at least 80% of the program completed, or graduate within the last year.
- Basic knowledge of ISO 13485 and FDA 21 CFR Part 820 (CGMP) is desired.
- Intermediate English proficiency (B1‑B2 level).
- 0‑1 year of work experience; experience in a medical‑device company is a plus.
Required skills
- Project management
- Quality engineering and reliability engineering techniques
- Statistical analysis and use of statistical tools
- Familiarity with ISO 13485 and FDA 21 CFR Part 820 (IQ, OQ, PQ)
- Knowledge of injection molding processes and equipment specifications
- Cost estimation for capital equipment
- Device History Record documentation
- Proficiency with spreadsheet, database and word‑processing software
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Published 1 month ago
Expires 2 days from now
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Viant Medical
Heredia