Senior Manufacturing Engineer en Costa Rica

hace 3 semanas

Alajuela, Costa Rica GSB A tiempo completo

**Importante empresa de carácter internacional, busca un Ingeniero en Manufactura con experiência requerida en la industria de DISPOSITIVOS MÉDICOS.**

**Indispensable**: +4-5 años con experiência requerida en la industria de DISPOSITIVOS MÉDICOS,
**Educación finalizada en**: Ingeniería Mecánica / Biomédica/ Ingeniero industrial, Químico, etc.
**Idioma**: Inglés(será evaluado en entrevista). Deberá comprender el idioma por la documentación que se maneja en inglés.
- **Responsabilidades**:_
- Reunir el equipo necesario, herramientas, información de los aparatos, especialización. Revisar el equipo más antiguo para ver si hay lagunas y las modificaciones necesarias, si las hay. Verificar el equipo para asegurar su idoneidad/orden para el propósito previsto. coordinar para presentar la orden de compra - obtener su orden.
- Revisar y evaluar la capacidad del proceso de mfg., Cpk, Ppk, robustez y caracterización. Revisar la caracterización para asegurar su validez y encontrar la ventana para la recaracterización. Crear un mapa de calor para mostrar los datos recogidos. Documentar el rendimiento, la producción.
- Validar el mfg, los procedimientos de prueba e inspección cuando sea apropiado: Identificación y reparación de las lagunas del proceso de GFG. 4. Observar el proceso/construcción actual de la GFM, estudiar el procedimiento aplicable de la GFM, identificar los vacíos, marcar los procedimientos aplicables, implementar los cambios en el SGC por el proceso de CO.
- Revisar los documentos de validación de la OQ, PQ y PPQ del equipo y del proceso de GFG, revisión de los riesgos del proceso.
- Estudiar el proceso de mfg. para documentar los procesos altamente dependientes del operador o cuán manual es el proceso. Crear un mapa representativo codificado por colores para planificar el tipo y la extensión de la capacitación requerida
- Recopilar los documentos del DMR, revisarlos para asegurar su integridad.
- Revisar los cambios en la etiqueta y en el IFU, documentar los cambios a implementar

**Requisitos**
- **Habilidades técnicas / Requisitos**_
- Evaluaciones de normalidad, análisis de capacidad, test t de 2 muestras, ANOVAs y GR&Rs, etc.)
- Conocimiento práctico de las pautas cGMP, FDA 21 CFR Part 820/210/211, pautas ICH
- Desarrollo de un procedimiento estándar (SP), instrucciones de trabajo (WI) relacionadas, formularios, listas de verificación, protocolos, informes y plantillas para instalaciones / servicios públicos, puesta en servicio del almacén y actividad de calificación.
- Comprensión de los principios, dispositivos y procedimientos neurovasculares
- Experiência con catéteres de balón y / o dispositivos de administración
- Experiência con dispositivos de Nitinol y métodos de procesamiento.
- Experiência en transferencia de productos y procesos

**Beneficios**
- **Lugar de trabajo**: Coyol, Costa Rica (En la zona Franca)
- Estabilidad laboral
- Prestaciones de ley
- **Sueldo atractivo**: 1,800,000 € brutos
- **Tipo de puesto**: Tiempo completo, Por contrato

Tipo de puesto: Tiempo completo

Salario: ₡1,600,000.00 - ₡1,800,000.00 al mes

Educación:

- Licenciatura terminada (Obligatorio)

Experiência:

- Minitab: 1 año (Obligatorio)
- en validación, redacción de procesos IQ, OQ, PQ: 2 años (Obligatorio)
- industria de DISPOSITIVOS MÉDICOS: 2 años (Obligatorio)

Idioma:

- Ingles - Avanzado (Obligatorio)

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