12/10/2024 updated
100 % available
MedTech & Life Sciences Systems Engineer and Project Manager
Huelva, Spain
Worldwide
BSc. in Biochemistry with a Mention in BiotechnologyArtificial IntelligenceData AnalysisSystems EngineeringBiochemistryBiotechnologyISO 9000Change ControlCommunications ManagementRegulatory ComplianceDesign of ExperimentsISO 13485Project ManagementMicrofluidicsMinitabParametrization
Systems Engineering
Expertise in product design and development for complex MedTech and Life Sciences systems, product requirements and specifications definition and analysis, traceability matrix management, system architecture, functional and form decomposition, functional analysis, parametrization and modeling, design change control, V-model, V&V.
Project Management
Proficiency in leading multidisiplinary teams and international hybrid consortia, product development campaigns (documentation, planning, progress, budget monitoring and control), and stakeholder communication management across all levels.
Knowledgeable of Agile and PMI project management disciplines.
Biochemistry, Biotechnology, Microfluidics and IVD Technologies
Specialized knowledge and expertise in devices and systems harnessing Biochemistry, Biotechnology, Microfluidics, including POCT and diagnostic applications for various diseases.
IT Tools Proficiency
Skilled use of documentation, collaboration, and communication tools such as Microsoft Office, Google Workspace, and Miro. Experience with AI tools for enhanced professional use.
Data analysis and Design of Experiments
Competence in using Minitab for experimental design, including multiparameter alignment tolerance sensitivity analysis for transfer-to-manufacturing processes.
Quality Management, Regulatory Compliance and Risk Management
Knowledge of medical device industry ISO standards (ISO9001, ISO13485, ISO14971) and regulatory framewor (IVDR/MDR).
Design engineering, Data Analysis and Management
Proficiency in using Microsoft Excel for design engineering, data management, and analysis. Experience with data-driven decision-making processes.
Expertise in product design and development for complex MedTech and Life Sciences systems, product requirements and specifications definition and analysis, traceability matrix management, system architecture, functional and form decomposition, functional analysis, parametrization and modeling, design change control, V-model, V&V.
Project Management
Proficiency in leading multidisiplinary teams and international hybrid consortia, product development campaigns (documentation, planning, progress, budget monitoring and control), and stakeholder communication management across all levels.
Knowledgeable of Agile and PMI project management disciplines.
Biochemistry, Biotechnology, Microfluidics and IVD Technologies
Specialized knowledge and expertise in devices and systems harnessing Biochemistry, Biotechnology, Microfluidics, including POCT and diagnostic applications for various diseases.
IT Tools Proficiency
Skilled use of documentation, collaboration, and communication tools such as Microsoft Office, Google Workspace, and Miro. Experience with AI tools for enhanced professional use.
Data analysis and Design of Experiments
Competence in using Minitab for experimental design, including multiparameter alignment tolerance sensitivity analysis for transfer-to-manufacturing processes.
Quality Management, Regulatory Compliance and Risk Management
Knowledge of medical device industry ISO standards (ISO9001, ISO13485, ISO14971) and regulatory framewor (IVDR/MDR).
Design engineering, Data Analysis and Management
Proficiency in using Microsoft Excel for design engineering, data management, and analysis. Experience with data-driven decision-making processes.
Languages
EnglishFluentSpanishNative speaker
Project history
Providing multidisciplinary and cross-functional engineering-driven design and project management services in hardware technology innovation, from idea to production handover.
Successfully completed and delivered +13 projects in various complex technologies (Medical, IVD, POCT, Life Sciences). Led project management, multidisciplinary teams, and carried out necessary process and product development activities.
Process design, development, and validation of low-pressure plasma-driven surface functionalization treatments and anti-aging strategies on thermoplastic polymers. Developed and verified a low-cost portable optical readout system for diagnostic applications.