Experteer Overview
In this role you will verify IVD systems and lead studies to optimize performance across instruments and reagent sets. You will support integration of Grifols IVD devices with total laboratory automation (TLA), middlewares, and LIS systems. You will draft verification reports, analyze data, and ensure compliance with safety and quality standards. This position offers the chance to influence automated diagnostic workflows and collaborate with global teams. Join a mission-driven environment focused on advancing healthcare through reliable, integrated diagnostics.

Compensaciones / Incentivos
• Participate in defining instrument-related aspects of automated diagnostics
• Analyze diagnostic technique steps performed by the instrument
• Support integration of IVD instruments with TLA tracks, middlewares, and LIS systems
• Establish interface requirements for TLA integration and parameters for diagnostic steps
• Verify instrument performance on diagnostic techniques
• IVD systems verification and report drafting
• Develop and execute Design Verification protocols at integration and product requirement levels
• Perform regression analysis and testing
• Evaluate deviations in verification protocols and tests




• Maintain lab cleanliness and safety compliance
• Review design requirements to identify critical aspects and ensure completeness
• Understand TLA IT infrastructure, networking solutions, and instrument connections
• Provide cross-departmental support on instrument and software functionality
• Generate and update project documentation (technical reports, methods)
• Review user manuals and project documentation
• Participate in Product Design Risk Analysis
• Ensure instruments, materials, and reagents meet requirements
• Participate in training of team members and advise users of IVD systems
• Analyze complaints to determine root cause and solutions
• Interpret HL7, ASTM, RS-232 logs for investigative studies on product complaints

Responsabilidades
• Bachelor's Degree in Engineering (Biomedical, Electronic, Industrial or related field)
• 3-5 years of experience in medical device or automotive industry
• Strong communication skills for global collaboration
• Problem-solving mindset and hands-on approach
• Knowledge of IVDR, ISO 13485, and 21CFR820 is a plus
• Advanced in English is a must

Requisitos principales
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📌 SYSTEMS ENGINEER SPECIALIST (San Cugat del Vallés)
🏢 Grifols
📍 San Cugat del Vallés