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 general 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 / BeneficiosBenefits packageHybrid work arrangementPermanent contractFlexible scheduleLocation: Parets del VallèsDiversity and equal opportunity commitment ResponsabilidadesDefine, coordinate, and document product and system specifications aligned with regulatory, manufacturing, and quality requirementsEnsure specification traceability across the system lifecycleLead and coordinate technical reviews with stakeholdersDefine and document system architectures meeting requirementsEnsure consistency between requirements, architecture, and implementationParticipate in technical decision-making for robust solutionsDefine, execute,



and document feasibility tests and analysesDesign test setups for feasibility studies and document resultsLead risk analysis reviews for IVD systems and propose improvementsOrganize cross-functional meetings for system definition, feasibility, and integrationDevelop work procedures and technical instructionsManage team activities using Agile methodologiesMaintain accurate and up-to-date documentationApply and promote Quality System procedures Requisitos principalesUniversity degree in Engineering, Systems Engineering, Electronics, Computer Science, Biotechnology, Health Sciences or related field2–5 years of experience in technical roles related to systems engineering, product development or complex technologiesAdvanced English (spoken and written)Strong knowledge of systems engineering for complex, regulated productsAbility to analyze system behavior, interfaces and constraintsExperience with technical documentation, traceability, and structured problem analysisKnowledge of risk analysis and risk management in regulated environmentsAbility to translate requirements into technical specificationsFamiliarity with Agile methodologies in engineering/product developmentProficiency with office productivity tools and technical document management systemscross-functional collaborationeffective communicationanalytical thinkingSystems Engineering principlesrequirements-to-architecture traceabilityrisk analysis and management for regulated environments

📌 IVD Systems Engineering Specialist (Barcelona)
🏢 Jobrapido
📍 Barcelona