Experteer Overview
Si sus habilidades, experiencia y cualificaciones coinciden con las de esta descripción del puesto, no demore su solicitud.
Join Grifols to lead verification and performance optimization for IVD systems. You will evaluate instrument and reagent set performance, troubleshoot at system level, and support hardware-software integration within total laboratory automation. You’ll collaborate across global teams to ensure compliant, reliable diagnostic solutions and contribute to improving healthcare outcomes. This role offers hands-on impact in a regulated, tech-driven environment with strong interdisciplinary collaboration. You will help shape how automated diagnostics meet high standards of quality and patient safety.
Compensaciones / Beneficios
• Define instrument-related aspects of automated diagnostic techniques and analyze procedural steps for instrumentation.
• Support integration of Grifols IVD instruments with TLA tracks, middlewares, and LIS/LAS systems.
• Establish interface requirements for TLA integration including timing, sample volume, and process parameters.
• Verify instrument performance on diagnostic techniques.
• Analyze and draft final verification reports; draft/execute Design Verification protocols at integration and product requirement levels.
• Perform regression analyses and testing; assess deviations in verification and regression results.
• Maintain lab cleanliness and safety compliance; ensure equipment, materials, and reagents meet requirements.
• Review design requirements, identify critical aspects, and support IT/infrastructure for instrument connections, firewalls, LIS, and LAS.
• Generate/update project documentation; review manuals; participate in Product Design Risk Analysis. xpzdshu
• Provide training to team members and advise users of IVD systems.
• Analyze complaints related to diagnostic techniques and TLA integration; investigate root causes using instrument/software interface logs (HL7, ASTM, RS-232).
Responsabilidades
• Bachelor’s degree in Engineering in a relevant field
• 3–5 years of experience in a regulated medical device or automotive environment with strong documentation
• Strong communication skills for interactions with global teams and stakeholders
• Problem-solving mindset with willingness to take initiative
• English proficiency is essential
• Nice-to-have: IVDR, ISO 13485, 21CFR820 knowledge
Requisitos principales
• Hybrid Model
• Flexible schedule
• Permanent contract
• Location: Sant Cugat del Vallès, Spain