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Ubicación:
Worcester
Categoría:
Pruebas y Garantía de Calidad

Workable
Ingeniero de Verificación de Software
JD
Resumen del trabajo
Estamos buscando un Técnico de Verificación de Software para Dispositivos Médicos meticuloso y orientado al detalle para unirse a nuestro equipo. El candidato seleccionado será responsable de verificar el software utilizado en nuestros dispositivos médicos y garantizar el cumplimiento con los estándares regulatorios y los requisitos internos de calidad. Esta función implica diseñar, implementar y ejecutar planes y procedimientos de prueba para identificar y documentar defectos del software.
Principales responsabilidades
• Planificación y diseño de pruebas
• Desarrollar planes de prueba completos, casos de prueba y scripts de prueba basados en los requisitos del software y especificaciones de diseño.
• Asegurar que los planes de prueba cubran todos los requisitos funcionales y no funcionales, incluyendo rendimiento, confiabilidad y seguridad.
Ejecución de pruebas
• Ejecutar pruebas manuales y automatizadas para identificar defectos en aplicaciones de software.
• Realizar pruebas de regresión para asegurar que las funcionalidades existentes no se vean afectadas por cambios nuevos.
• Realizar pruebas exploratorias para descubrir posibles problemas no identificados por casos de prueba formales.
Documentación e informes
• Documentar resultados de pruebas, incluyendo descripciones detalladas de defectos y pasos para reproducirlos.
• Generar y mantener informes de pruebas, registros de defectos y otra documentación requerida para cumplimiento regulatorio.
• Comunicar resultados de pruebas y estado de defectos a los equipos de desarrollo y a la gerencia.
Colaboración
• Trabajar estrechamente con desarrolladores de software e ingenieros de sistemas para comprender los requisitos y funcionalidades del software.
• Cumplimiento y normas
• Asegurar que las actividades de prueba cumplan con las normas regulatorias relevantes (por ejemplo, FDA, ISO 13485, IEC 62304).
• Mantenerse actualizado con las mejores prácticas de la industria y los requisitos regulatorios cambiantes para el software de dispositivos médicos.
Requisitos
Educación
Título universitario en Ciencias de la Computación, Ingeniería de Software, Ingeniería Biomédica o campo relacionado.
Experiencia
• Mínimo de 5 años o más de experiencia en pruebas de software, preferiblemente en la industria de dispositivos médicos.
• Experiencia con herramientas y marcos de prueba (por ejemplo, ClearQuest, Jama).
• Conocimiento de las normas y directrices regulatorias para dispositivos médicos (por ejemplo, FDA 21 CFR Parte 820, ISO 13485, IEC 62304).
Habilidades y competencias
• Sólido conocimiento de metodologías de desarrollo y pruebas de software.
• Excelentes habilidades analíticas y de resolución de problemas.
• Atención al detalle y alto nivel de precisión.
• Dominio de lenguajes de programación o scripting (por ejemplo, Python, Java) para automatización de pruebas.

Newton, MA, USA
Salario negociable
Puestos populares
Ciudades populares