Systems Engineering Specialist

Experteer Overview In this role you verify Grifols IVD instruments and support their integration with total laboratory automation.You work with cross-functional teams to define instrument automation aspects and ensure performance across instrument and reagent sets.You analyze diagnostic steps, draft verification and design verification documents, and troubleshoot system-level issues.You contribute to compliant, data-driven verification activities that support safe, effective diagnostic solutions at scale.Compensaciones / Beneficios * Define instrument automation aspects for diagnostic techniques * Analyze steps of diagnostic techniques performed by the instrument * Support integration of IVD instruments with TLA tracks, middlewares, and LIS/LAS * Establish interface requirements and parameters for TLA integration * Verify instrument performance on diagnostic techniques * Draft/execute IVD systems verification and design verification protocols * Collect data and perform regression analysis and testing * Review design requirements and provide cross?department support regarding instrument and software functionality * Analyze complaints and interpret interface logs (HL7, ASTM, RS-232) to determine root causes Responsabilidades * Bachelor’s Degree in Engineering (Biomedical, Electronic, Industrial or related field) * 3-5 years of experience in medical device or automotive industry in regulated environments * Strong communication skills with global teams and stakeholders * Problem-solving ability and proactive mindset * Certifications: IVDR, ISO *****, 21CFR820 (nice to have) * Advanced in English Requisitos principales *

Compensaciones / Beneficios * Define instrument automation aspects for diagnostic techniques * Analyze steps of diagnostic techniques performed by the instrument * Support integration of IVD instruments with TLA tracks, middlewares, and LIS/LAS * Establish interface requirements and parameters for TLA integration * Verify instrument performance on diagnostic techniques * Draft/execute IVD systems verification and design verification protocols * Collect data and perform regression analysis and testing * Review design requirements and provide cross?department support regarding instrument and software functionality * Analyze complaints and interpret interface logs (HL7, ASTM, RS-232) to determine root causes Responsabilidades * Bachelor’s Degree in Engineering (Biomedical, Electronic, Industrial or related field) * 3-5 years of experience in medical device or automotive industry in regulated environments * Strong communication skills with global teams and stakeholders * Problem-solving ability and proactive mindset * Certifications: IVDR, ISO *****, 21CFR820 (nice to have) * Advanced in English Requisitos principales *