Experience

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  MYNERVA

  • Zurigo, Svizzera

  • Chief Technology Officer

    • Feb 2024 - Present
    • Zurigo, Svizzera

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  BrightInsight

  • Zurich, Switzerland

  • Sr. Manager Systems Engineering

    • Sep 2021 - Jan 2024
    • Zurich, Switzerland

    As part of the Professional Services team at BrightInsight, I contribute significantly to the advancement of BI global platform and products for biopharma and medtech regulated digital health solutions. BrightInsight is a leader in assisting top companies to expedite time-to-market for various regulated digital health offerings, including apps, algorithms, medical devices, combination products, and Software as a Medical Device (SaMD).Key contributions:* Play a key role in initiatives aimed at expediting the development and launch of regulated digital health solutions, by defining user needs and requirements and transferring to technical teams.* Contribute to the introduction of innovative approaches, replacing traditional 'built from scratch' implementations. Actively involved in implementing configurable software modules on BI regulated platform, built under a robust Quality Management System.* Contribute to ensuring global security, privacy, and regulatory requirements are met by leading risk and security management activities to ensure compliant design and implementation of the solutions.

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  ndd Medical Technologies

  • Zürich Area, Switzerland

  • Technical Product Manager, Design Quality

    • Sep 2019 - Sep 2021
    • Zürich Area, Switzerland

    As technical product manager, I was responsible to define all technical aspects of lung function testing devices manufactured by NDD, within the entire product life cycle.Key contributions:* Requirements engineering and design control activities (specifications, risk management, usability,verification and validation) for company products* Project management for assigned product-related projects* Define quality management processes for product development and realization, risk management and post-market surveillance activities, in compliance with QMS, 21 CFR 820 and MDR* Establish product specifications based on requirements in collaboration with R&D, regulatory and relevant stakeholders* Management of product entire product life-cycle from concept to market phase* Contribute to product documentation and trainings (e.g. tutorials, spec sheets, manuals, training materials for Sales)• Continuous monitoring of markets for Innovation

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  Altran

  • Zürich Area, Svizzera

  • Senior Consultant

    • Feb 2019 - Sep 2019
    • Zürich Area, Svizzera

    As senior consultant for health technologies, I contributed to several projects within the medical device and life science industry.Key contributions:* Lead project activities for product realization, mainly including integrated ecosystems for digital healthcare domain (i.e. integrated devices, IoT, medical grade and general purpose sensors, cloud computing, medical dashboards, etc.).* Provide expertise on quality and regulatory compliance for Software embedded in Medical Devices (SiMD) or as Medical Devices (SaMD).

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  Biovotion

  • Zürich Area, Switzerland

  • Design Quality Manager/Head of Software Development

    • Jul 2017 - Feb 2019
    • Zürich Area, Switzerland

    Head of mobile development team to build an innovative digital health Ecosystem solutions for healthcare wearable devices (e.g., measuring/visualization, IoT solutions, big data, cloud storage, etc.).Responsible for compliance to applicable regulations, international standards and internal procedures for all activities within the R&D department. Key contributions:* Provide quality and compliance expertise related to product development processes (Design control, change control, release management, risk management, verification and validation).* Ensure quality and safety by design and compliance to internal procedures of implemented solutions.* Define software/HW life cycle processes and manage capability and improvements.* Lead mobile development and act as Software Product owner for the Biovotion ecosystem products.* Lead activities and deliverables for software Design History File.* Act as quality gateway to internal procedures and regulatory functions (including regulatory agencies) to monitor engineering team compliance.

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  Prismond Group AG

  • Zürich Area, Switzerland

  • MedTech development and compliance consultant

    • May 2016 - Dec 2017
    • Zürich Area, Switzerland

    Senior quality consultant for design and development of medical devices, including software and electronics, in compliance with quality standards and regulatory requirements (EU and US). Key contributions:* Quality Management System: establish processes for for risk management, product realization, software life-cycle, continuous improvement (incl. CAPA management), post-market surveillance and provide audit support, in compliance with ISO 13485 and 21 CFR 820.* Verification and Validation: define V&V plans, verification strategies and approaches, contribute to test execution, managing deviations and reporting.*Technical File: establish DHF activities, author, contribute and review risk management and design control deliverables

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  Freelance Consultant - Altran Italia S.p.A.

  • Rome (IT), Zurich (CH)

  • Advanced Consultant - SW/IT Quality

    • Jan 2013 - Feb 2016
    • Rome (IT), Zurich (CH)

    As advanced consultant, I contributed to several projects within the medical device and biopharma industries.Key contributions:* Validation Team Lead, IT Quality and Application ManagerMain systems: Electronic Data Management Systems (EDMS), Clinical Trail Management Systems (CTMS), Manufacturing Execution Systems (MES), Chromatography Data Systems (CDS) and other Laboratory and Research systems).* Software Project Management and SW Regulatory Consultant to comply with ISO 13485 Quality Management Systems and software/electronics related standards (IEC 60601, 62304, 62366)

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  CISTIB - Universitat Pompeu Fabra

  • Barcelona Area, Spain

  • Lead Scientific Software Development Team

    • May 2009 - Dec 2012
    • Barcelona Area, Spain

    Lead software team for design and development of prototypes and research applications for medical imaging and image guided intervention. Development of scientific platforms for rapid prototyping of innovative clinical and research applications.Key contributions:* Define software team activities.* Manage scientific deliverables (national/EU research grants, industrial contracts).* Establish state-of-the-art software development methodology (Agile/Scrum); and CD/CI tools.* Design innovative algorithms/patents for medical imaging and physiological modeling.* Coordinate industrial transfer deliverables with business stakeholders and industrial partners.

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  NewCorTec, Tecnobiomedica

  • Rome Area, Italy

  • Software Development Lead

    • May 2003 - Jan 2009
    • Rome Area, Italy

    R&D electronic engineer for clinical and industrial projects in cardiovascular and oncological domains. Software Development Lead for realization and commercialization of an innovative Ventricular Assist Device (VAD), manufactured by NewCorTec.Key contributions:• Physiological Modeling of advanced treatments (e.g., echo-contrast, radio-frequency ablation, image-based cancer detection, etc.)• Software Lead for monitoring and control of NewCorTec Ventricular Assist Device.• Software Development Life cycle processes in compliance with ISO 13485.• Technical documentation (software and firmware components) for NewCorTec VAD design dossier• Field engineer to support clinical trials of NewCorTec VAD.