Molding Engineer 3 (Injection & Extrusion)
Viant Medical · Heredia
Descripcion del puesto
About the role
We are looking for a Molding Engineer 3 to join our Heredia site in the Zona Franca Metropolitana. The engineer will support the development, transfer and validation of injection molding and extrusion processes, ensuring compliance with Viant’s procedures and customer requirements.
Key responsibilities
- Support and enforce safety, EHS initiatives, GMP and SOP compliance across the campus.
- Coordinate development of new injection molding and extrusion processes with product design, quality, production and external vendors.
- Execute process development, qualification and validation activities (IQ, OQ, PQ) for new products and process changes.
- Prepare validation protocols, reports and required documentation such as Device Master Records and Device History Records.
- Provide technical support for quoting new projects, including cycle‑time estimation and equipment investment analysis.
- Collaborate with program managers, value‑stream managers, production, QA, supply chain, maintenance and equipment vendors.
- Prepare and present regular reports on task completion and recommend improvements.
Required profile
- Experience working under the direction of an Engineering Director or Manager in a plastics manufacturing environment.
- Familiarity with FDA, ISO, GMP and SOP requirements for medical device manufacturing.
- Ability to work full‑time, Monday‑Friday, 8 am‑5 pm on‑site.
Required skills
- Injection molding process development
- Extrusion process development
- Qualification and validation (IQ, OQ, PQ)
- FDA regulatory knowledge
- GMP and ISO standards compliance
- Creation of Device Master Records and Device History Records
- Technical documentation and reporting
What we offer
- Opportunity to work on strategic plastics processing projects and new technology implementation.
- Collaboration with cross‑functional value‑stream teams and external vendors.
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Viant Medical
Heredia
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