Consultant in MedTech & Life Sciences: Systems engineering | Product Development | Project Management
Self-employed, Freelancer
Keywords
Data Analysis
Biochemistry
Biotechnology
Design of Experiments
Project Management
Microfluidics
Product Design
Design Engineering
Artificial Intelligence
Systems Engineering
Skills
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.
Project history
01/2024
-
Present
Providing multidisciplinary and cross-functional engineering-driven design and project management services in hardware technology innovation, from idea to production handover.
01/2021
-
12/2023
Product Developer, Lead Systems Engineer, Project Manager & Technology Expert
Voxdale B.V.
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.
01/2020
-
06/2021
Research Engineer associate System
Antelope Dx B.V.
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.
01/2019
-
12/2019
IVD Product Development Scientist
Microliquid S.L.
Lab-based R&D activities in Microfluidics and IVD technologies. Developed and validated lyophilization strategies of qPCR reagents for integration in microfluidic devices for diagnostic applications.
Local Availability
Open to travel worldwide
