Valentina Vitali

Systems & Requirements Engineering - Led a team of 3 engineers; translated stakeholder needs into system-level requirements and ensured regulatory compliance. - Oversaw system-level architectural design activities. Design Complaint Investigation & Validation - Led design validation activities demonstrating coverage of stakeholder requirements. - Oversaw system level complaints investigation. Usability / Human Factors - Led formative evaluations and Human Factors Validation testing; Led HF validation testing to approval for De Novo and 2 510(k) submissions. - Ensured compliance with IEC 62366, ISO 14971, and FDA Human Factors requirements. Instructions for Use (IFU) - Managed the IFU lifecycle, including development, updates, translations, accessibility, localization, and regulatory compliance (EU & US).

- Defined user needs in collaboration with the product team. - Led requirements engineering activities, specifically the translation of user needs into clear, traceable, and testable system requirements. - Led design validation activities (test case development, protocol definition, data leveraging, execution and supervision) in compliance with ISO 13485, MDR, and US 21 CFR 820. - Led human factors engineering / usability engineering activities, including use-error and risk assessment, and organization of formative and summative evaluations; contributed to the De Novo Human Factors Validation approval of Dexter. - Owned the IFU lifecycle, including development, updates, naming conventions, translations, accessibility, localization, and regulatory compliance for EU and US markets.

- Led design validation activities, including development of test cases, protocol definition, leveraging of existing data, and the execution and supervision of validation tasks in simulated-use environments. - Directed usability engineering activities: identified, consolidated and assessed potential use errors, use risks, and hazard-related use scenarios; developed, refined, documented and tested user journeys; designed appropriate use-risk control measures and evaluated their effectiveness; coordinated both formative and summative usability evaluations. - Ensured full compliance with ISO 13485, MDR, US 21 CFR 820, IEC 62366, ISO 14971, and FDA Human Factors Engineering requirements. - Owned the Instruction for Use (IFU) lifecycle, including development, updates, naming conventions, translation workflows, accessibility, localization, and alignment with European and U.S. regulatory requirements.

- Led system integration, characterization, performance optimization, and instrument troubleshooting across multiple product generations. - Contributed to system validation activities for both software and hardware, including definition of protocols, test scripts, reports, and documentation (validation summary reports, traceability matrices) following a risk-based approach. - Directed usability engineering activities: planning and executing usability studies, managing related documentation.

- Designed, assembled, and tested functional models and prototypes; performed troubleshooting to ensure optimal performance. - Conducted numerical modeling and simulations to support performance analysis. - Installed devices at customer sites and provided hands-on training to ensure effective and safe operation. - Investigated technical issues and developed rapid, practical solutions to minimize downtime. - Participated in QA/QC activities, including handling customer complaints and contributing to SOPs, WINs, and CAPAs.

- Performed material research and analytical characterization to support device development and performance optimization. - Designed acoustophoretic devices and carried out clean-room microfabrication, testing, and validation activities. - Contributed to the Horizon 2020 “BioWings” project, focusing on the development of smart materials for next-generation medical systems. - Co-authored a peer-reviewed publication: Vitali, V., Core, G., Garofalo, F. et al. “Differential impedance spectra analysis reveals optimal actuation frequency in bulk mode acoustophoresis,” Scientific Reports, 9, 19081 (2019). - Delivered an oral presentation at MicroTAS 2018 (Kaohsiung, Taiwan).

I have developed an innovative method to select optimal actuation frequencies in microfluidic systems (acoustophoretic devices) by means of a differential impedance spectral analysis (patent application). Award for best master thesis at LTH 2018

T.I.M.E double degree program at the faculty of engineering at Lund University. The Top Industrial Managers for Europe (T.I.M.E.) program is a bilateral agreement between Lund University and Politecnico di Milano that allows to obtain the degree from both the universities. The program consists of three years of Master of Science: one at Politecnico di Milano and two at Lunds University.

During the "Amazing Brain" science week I have presented my research focused on the study of the signals elicited by the Venus Fly Trap, also known as carnivorous plant. My work was centered on the study of the signals elicited by the plant in comparison to the action potential of human brain cells.

Part of the Double Degree Program - Biomechanics and Biomaterials GPA 4.0

Part of the Double Degree Program - Signals and E-Health GPA 3.9

Thesis: "Electrochemical surface modifications of titanium and titanium alloys for bio-implants applications".