Overview

In this role you will drive end-to-end system integration for IVD solutions, ensuring alignment with regulatory, manufacturing and quality requirements. You will work within the Instrument Development & Life Cycle Management team to deliver robust, compliant systems. You will lead technical reviews, define architectures, and oversee validation and risk analysis activities. This position offers impact across product development in a global healthcare company and an opportunity to shape how complex systems meet stringent standards. You will collaborate with cross-functional teams in a highly regulated environment to enable scalable, quality-driven solutions.

Compensaciones / Ventajas

- Benefits package
- Hybrid work arrangement
- Permanent contract
- Flexible schedule
- Location: Parets del Vallès
- Diversity and equal opportunity commitment

Responsabilidades

- Define, coordinate, and document product and system specifications aligned with regulatory, manufacturing, and quality requirements
- Ensure specification traceability across the system lifecycle
- Lead and coordinate technical reviews with stakeholders
- Define and document system architectures meeting requirements
- Ensure consistency between requirements, architecture, and implementation
- Participate in technical decision-making for robust solutions
- Define, execute, and document feasibility tests and analyses
- Design test setups for feasibility studies and document results




- Lead risk analysis reviews for IVD systems and propose improvements
- Organize cross-functional meetings for system definition, feasibility, and integration
- Develop work procedures and technical instructions
- Manage team activities using Agile methodologies
- Maintain accurate and up-to-date documentation
- Apply and promote Quality System procedures

Requisitos principales

- University degree in Engineering, Systems Engineering, Electronics, Computer Science, Biotechnology, Health Sciences or related field
- 2–5 years of experience in technical roles related to systems engineering, product development or complex technologies
- Advanced English (spoken and written)
- Strong knowledge of systems engineering for complex, regulated products
- Ability to analyze system behavior, interfaces and constraints
- Experience with technical documentation, traceability, and structured problem analysis
- Knowledge of risk analysis and risk management in regulated environments
- Ability to translate requirements into technical specifications
- Familiarity with Agile methodologies in engineering/product development
- Proficiency with office productivity tools and technical document management systems

- cross-functional collaboration
- effective communication
- analytical thinking
- Systems Engineering principles
- requirements-to-architecture traceability
- risk analysis and management for regulated environments

📌 IVD Systems Engineering Specialist - Grifols (Barcelona)
🏢 Grifols
📍 Barcelona