Resumen del rol

Principal Software Quality Assurance Engineer (Remote- United States)

Requisitos y responsabilidades

Contenido del rol extraído en secciones para revisar más rápido.

The Impact You’ll Make in this Role

  • Leading software assurance activities throughout medical device software life cycle, including creating software quality assurance plan, determining software safety classification, software test readiness, software release readiness. Responsible for ensuring traceability upwards to system level requirements and safety/security risk controls as well as downwards to software design, implementation and testing.
  • Being an active member of the software team during the whole software life cycle, with responsibility for physical and functional configuration audits, reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results, and providing insight to management regarding software project status and software quality metrics.
  • Ensuring compliance with applicable regulatory requirements and industry standards; performing gap assessments; immediately elevating to management any major problem with device software that could affect patient safety, cyber security, customer usability or system adherence to process requirements
  • Acting as a quality champion in software product development and testing teams
  • Supporting other software related processes such as CAPA process, and other quality related processes regarding cybersecurity risk management and software quality assurance.

Your Skills and Expertise

  • Master’s degree or higher in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security, or Information Science (completed and verified prior to start) and five (5) years of experience in software quality assurance in medical device, aerospace, or automotive industry

OR

  • Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security or Information Science (completed and verified prior to start) and seven (7) years of experience in software quality assurance in medical device, aerospace, or automotive industry

OR

  • Working knowledge of premarket and postmarket medical device regulations (FDA, EU and other agencies), as well as medical device related standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series amongst others.
  • Experience developing and testing software systems, SaMD, SiMD, and/or embedded software and creating appropriate documentation
  • Knowledge of Software Engineering best practices and working knowledge of C language preferred
  • Experience with embedded systems, IoT, Bluetooth, wi-fi and cellular technologies
  • Excellent verbal and written communication skills, strong problem-solving ability, and attention to detail
  • Ability to effectively manage multiple simultaneous tasks and priorities and perform under a dynamic environment with parallel product releases and multiple project teams
  • Ability to deal effectively with other employees and external business contacts while conveying a positive, service-oriented attitude.

Work location:

  • Remote in United States (preferred near Eagan, MN or San Antonio, TX area)
Roles similares

Mantén una lista de respaldo.

Ver roles
FocoSoftware Quality AssuranceÁrea del rol
Señal de senioritySeniorNivel del candidato
StackStack listado en la descripciónSkills principales
Ubicación38 países aceptadosElegibilidad

Stack

Usa estas tags para comparar roles remotos similares.

Elegibilidad de ubicación

Candidatos deberían aplicar solo cuando el país del perfil aparece aquí.

Flujo de contratación

WithMira muestra el rol y luego envía candidatos a la aplicación de la empresa.

1Revisa fit del rol, stack y elegibilidad de ubicación en WithMira.
2Abre la página de aplicación de la empresa desde el link rastreado.
3Guarda el rol o suscríbete a oportunidades similares antes de salir.
Aplicar en el sitio de la empresaSitio de la empresaAbrir link