09/08/2026 updated
100 % available
MedTech & Life Sciences Systems Engineer and Project Manager
Huelva, Spain
Worldwide
BSc. Biochemistry and Biotechnology; M. Project Management; Postgraduate Systems EngineeringAbout me
Technical leadership and ownership of problem-solving processes. +10 years of international experience across 4 countries (ES, NL, BE, DK). +15 projects in MedTech and Life Sciences across 5 companies as well as freelancing/consulting.
Systems EngineeringMedical EquipmentsBiochemistryBiomedical EngineeringBiotechnologyBiomedical TechnologyISO 13485Project ManagementManufacturing Execution System (MES)MicrofluidicsProduct DesignDesign EngineeringSystems ArchitectureSystems DesignProject Engineering
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.
Experience
Professional experience10+ years
Freelancer since2024
Languages
EnglishFluentSpanishNative speaker
Project history
Delivered product development and systems engineering consulting services to Space Tech and Diagnostics start-ups in the early stages of product development.
Led a multidisciplinary project team of 15+ people and CMOs to attain the technical and operational readiness of internal and outsourced manufacturing processes for commercial launch of a Class III drug-combination device.
Directed technology transfer of validated production equipment into GMP cleanroom manufacturing, enabling successful production ramp-up.
Led structured RCA of production issues and Kaizen initiatives, delivering cost savings, reduced operational waste, and strengthened process control via automated data-driven workflows.
Led delivery of 13+ multidisciplinary product development and engineering consultancy projects across medical device, IVD, and life science technologies, including 2 international consortia of EU-funded programs.
Owned project scoping, planning, resourcing, and commercial proposals, contributing to the acquisition of 5+ new client accounts.
Led design and commissioning of a microfluidics innovation facility, including prototyping and testing methods.
Certificates
Program in Architecture and Systems Engineering
MIT xPRO2025
Implementing Regulatory Requirements (MDR)
SGS2025
Generating data for technical documentation (IVDR)
SGS2025