Hybrid IVD Systems Engineer – Lifecycle & Compliance

Grifols; Parets del Vallès; Híbrido; EUR 48.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Flexible schedule

Permanent position

Descripción de la vacante

Grifols, a global healthcare leader, seeks a Systems Engineering Specialist to join the IVD Systems Department in Parets del Vallès. The role focuses on defining and validating system specifications, ensuring traceability, and aligning with regulatory and quality requirements.

You will lead cross-functional reviews, document architectures, and drive risk analyses within an Agile framework, contributing to compliant, robust solutions in a regulated setting.

Formación

• University degree in Engineering, Systems Engineering, Electronics, Computer Science, Biotechnology or related field.
• 2–5 years of professional experience in technical roles related to systems engineering, product development or complex technologies.
• Advanced level of English, both written and spoken.

Responsabilidades

• Define, coordinate, oversee and document product and system specifications aligned with functional, regulatory, manufacturing and quality requirements.
• Ensure the consistency, completeness and traceability of specifications throughout the system lifecycle.
• Lead and coordinate technical reviews of specifications with all relevant stakeholders.
• Define, coordinate and document system architectures that meet approved requirements and specifications.
• Ensure technical consistency between requirements, architecture, and implementation constraints.
• Participate in technical decision-making to ensure feasibility of solutions.
• Define, execute and document tests and analyses to evaluate feasibility of system solutions.
• Design and define test setups for feasibility studies.
• Analyze results and ensure proper documentation and traceability.
• Lead and participate in risk analysis reviews for IVD systems.
• Identify improvement actions and monitor their implementation.
• Lead cross-functional meetings on system definition, feasibility and integration.
• Develop work procedures and technical instructions for department activities.
• Organize and prioritize team activities using Agile methodologies.

Conocimientos

Systems Engineering

Technical documentation

Risk analysis

Agile methodologies

English proficiency

Educación

Engineering degree

Herramientas

Office productivity tools

Document management systems

Descripción del empleo

Grifols, a global healthcare leader, seeks a Systems Engineering Specialist to join the IVD Systems Department in Parets del Vallès. The role focuses on defining and validating system specifications, ensuring traceability, and aligning with regulatory and quality requirements.

You will lead cross-functional reviews, document architectures, and drive risk analyses within an Agile framework, contributing to compliant, robust solutions in a regulated setting.