Product Engineer - Medical Device Manufacturing
ConfidentialJob Description
Descripción y detalle de las actividadesThe Product Engineer will be responsible for supporting the manufacturing and continuous improvement of medical devices, ensuring product quality, efficiency, and compliance with regulatory standards.This role acts as a key liaison between design, quality, and production teams.
**Key Responsibilities**:- Support the transfer and launch of new medical device products into manufacturing.
- Lead product and process improvements to increase efficiency and reduce cost.
- Maintain product documentation, including drawings, BOMs, and specifications.
- Troubleshoot product and process issues on the production floor.
- Ensure compliance with ISO *****, FDA QSR, and other applicable regulations.
- Coordinate Engineering Change Orders (ECOs) and product updates.
- Participate in validations (IQ, OQ, PQ) and risk assessments (FMEA).
- Work closely with Quality, R&D, and Manufacturing teams.Experiência y requisitos**Qualific...
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