Francesco Usai
Richterswil
Summary
Recent PhD graduate with 2 years of experience in quality management affairs in the field of medical devices. Passionate about leveraging technology to improve the quality of life, a common thread throughout a career which I built at the intersection of biomedical engineering, psychology, neuroscience, and regulatory affairs. As a Junior Quality Manager at Ziemer Ophthalmic Systems, I will bring a deep expertise in biomedical technologies, familiarity with quality management affairs, and a pragmatic, result-oriented mindset to ensure that the company’s products and processes meet the highest quality standards while complying with regulations.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Digital Health Support
NeuroPro AG
08.2022 - 03.2024
- Setup Quality Management System according to ISO 13485 requirements
- Trained teammates on quality management issues
- Conducted risk management activities according to ISO 14971, with focus on software as medical device
- Conducted formative and summative usability studies according to IEC 62366
- Compiled technical documentation according to Annex II of Medical Device regulation (EU 2017/745)
- Determined user needs and product requirements of new medical imaging viewer supporting MRI, CT and ECG images
- Carried out onboarding of new customers, delivered demos and training sessions, and assisted existing customers with technical support
- Gathered and communicated user feedback to software engineers, ensuring successful integration into improved versions of product
Doctoral Researcher
NeuroCognitive Imaging Lab
09.2014 - 07.2024
- Developed prototype of online, home-based therapy for aphasia
- Conducted iterative testing (via usability studies) and product improvement based on user feedback
- Conducted preliminary assessment of product efficacy
- Conducted comprehensive literature reviews to inform research direction and hypotheses development.
Research Assistant
Conrad Lab
10.2021 - 04.2022
- Conducted literature reviews to support hypothesis development and identify gaps in existing knowledge.
- Conceived and operationalized two experiments designed to detect mind-wandering episodes using both behavioral and neurophysiological measures (EEG)
- Contributed to the publication of research articles in peer-reviewed journals, showcasing expertise in various topics.
Research Intern
Laboratory for Brain Recovery and Function
09.2016 - 08.2017
- Led data collection process on effect of Transcranial Magnetic Stimulation (TMS) on motor learning
- Wrote manual on neurophysiological mechanisms mediating effects of TMS on behavior and brain plasticity
Research Intern
Hierarchical Anticipatory Learning Lab
09.2015 - 08.2017
- Conducted literature reviews to identify relevant research articles and support project objectives.
- Employed Deep-Learning to detect presence of sleep spindles in EEG data
Research Intern
Neuroscience Aphasia Research Unit
02.2014 - 07.2014
- Conducted analysis of EEG on data from subjects with Wernicke´s Aphasia to characterize neural correlates of disfunctional auditory processing
Education
Advanced Studies - Clinical, Regulatory, Quality Affairs
Fachhochschule Nordwestschweiz
Muttenz, Switzerland09.2024
Ph.D. - Psychology And Neuroscience
Dalhousie University
Halifax, Canada07.2024
Master of Science - Bioengineering
University' Degli Studi Di Genova
Genova, Italy07.2013
Bachelor of Science - Biomedical Engineering
Universita’ Degli Studi Di Cagliari
Cagliari, Italy02.2011
Skills
- Regulatory Background: Medical Device Regulation (EU 2017/745), General Data Protection Regulation (EU
2016/679), Swiss Federal Act on Data Protection (nFADP), Artificial Intelligence Act (EU 2024/1689) - ISO/IEC Standards: ISO 13485, ISO 14971, ISO/IEC 62336; ISO/IEC 62304, ISO 42001, ISO 23894
- Document Creation: MS Office, LaTex, Markdown
- Soft Skills: Problem Solving, Self-learning, Resilience, Flexibility, Independent, Pragmatic
Certification
Certificate of Advanced Studies in Clinical, Regulatory and Quality Affairs
Languages
Timeline
Digital Health Support
NeuroPro AG
08.2022 - 03.2024
Research Assistant
Conrad Lab
10.2021 - 04.2022
Research Intern
Laboratory for Brain Recovery and Function
09.2016 - 08.2017
Research Intern
Hierarchical Anticipatory Learning Lab
09.2015 - 08.2017
Doctoral Researcher
NeuroCognitive Imaging Lab
09.2014 - 07.2024
Research Intern
Neuroscience Aphasia Research Unit
02.2014 - 07.2014
Advanced Studies - Clinical, Regulatory, Quality Affairs
Fachhochschule Nordwestschweiz
Ph.D. - Psychology And Neuroscience
Dalhousie University
Master of Science - Bioengineering
University' Degli Studi Di Genova
Bachelor of Science - Biomedical Engineering
Universita’ Degli Studi Di Cagliari
Similar Profiles
BENJAMIN MIEKISIAKBENJAMIN MIEKISIAK
Market Area Head Emerging Markets at UBS AG / CREDIT SUISSE AGMarket Area Head Emerging Markets at UBS AG / CREDIT SUISSE AG
MICHELE SIMMENMICHELE SIMMEN
Executive / Operational Assistant at Simulands AG / SwissVortex AGExecutive / Operational Assistant at Simulands AG / SwissVortex AG
Diana CalifanoDiana Califano
Legal & Compliance Assistant (40-60%) at Juris Audit AG (AML Revisions AG)Legal & Compliance Assistant (40-60%) at Juris Audit AG (AML Revisions AG)