I am a bioengineer, really curious and passionate for the healthcare field. I am always motivated to try to bridge the gap between research and real-world applications for improving quality of life. My background and 8+ years’ experience in R&D in the Medical Device field brought me to explore many interesting topics, allowing me to gain cross-domain knowledge, starting from devices concept to their commercial launch, and fully covering activities related to fundraising, budgeting, project/product and operations management, quality, and regulatory affairs.I have achieved recognized working and scientific results, managing stressful periods and meeting work deadlines. I am a friendly and goal-oriented person with good flexibility attitudes. The possibility to work in multidisciplinary environments, to learn new skills and new technologies, also highly different from my background, are extremely attractive to me.Currently I am the person in charge of the management of the operations and the Q&R compliance of Henesis srl.
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Operations ManagerHenesis May 2024 - PresentParma, Emilia-Romagna, ItalyPrimary responsibilities and tasks: person in charge of overseeing the internal processes of the Company, ensuring efficient and effective operations. Management of resources, coordinate between departments, and implementation of processes to optimize productivity and quality. Responsibilities include budgeting, scheduling, staff management, full supply chain and production management, and monitoring performance to align with Company’s goals. Additional Responsibilities: management of the IP Portfolio, outline new research and business opportunities in internal and open-innovation projects. Member of the Company Steering Committee offering scientific, technical, and regulatory thinking. -
Quality Assurance Regulatory Affairs ManagerHenesis S.R.L. Jul 2021 - PresentParma, Emilia-Romagna, ItalyPrimary responsibilities and tasks: person in charge of the implementation and maintenance of the QMS in compliance with ISO13485. Person Responsible for Regulatory Compliance (PRRC) of the Company, with filing and maintenance of the main documents requested by MDR. Knowledge and use of the main standard related to MD (ISO13485, ISO14971, IEC62304, IEC60601-1,-2,-11, IEC62366, ISO10993). -
Projects Portfolio ManagerHenesis S.R.L. Jul 2021 - May 2024Parma, Emilia-Romagna, ItalyPrimary responsibilities and tasks: management of the whole projects’ portfolio ranging from wearables sensors to medical devices. Supervision of the R&D team. Scouting and outline of new research and business opportunities in internal and open-innovation projects, including Horizon Europe proposals. Member of the Company Steering Committee. -
PlannerCamlin Group Jul 2020 - Jun 2021Parma, Emilia-Romagna, ItalyPrimary responsibilities and tasks: management and allocation of the resources; monitoring the project plans with risks and issues analysis and mitigation; facilitate and stimulate the communication within and between the teams; outline new research and business opportunities in internal projects and open-innovation proposals -
Regulatory Affairs SpecialistCamlin Group Feb 2020 - Jun 2021Parma, Emilia-Romagna, ItalyPrimary responsibilities and tasks: definition of regulatory strategy of a home-rehabilitation device, in accordance with MDR -
Senior Research And Development EngineerCamlin Group Jun 2017 - Jul 2020Parma, ItaliaPrimary responsibilities and tasks: electromechanics technical lead and project manager in the internal project aimed at developing a device for home-rehabilitation. Fundraising and scouting of new opportunities for internal projects and H2020 proposals -
Postdoctoral ResearcherScuola Superiore Sant'Anna Oct 2015 - May 2017Pisa, ItaliaPostdoctoral Researcher, Member of the Translational Neural Engineering Laboratory. Main Achievements: Technical and project management, Neural Signal and Image Processing and Study of rehabilitation after stroke -
Research CollaboratorConsiglio Nazionale Delle Ricerche Nov 2011 - May 2017PisaResearch Collaborator, Member of the Joint Laboratory Neuroscience Institute – The Biorobotics Institute Main Achievements: Design, setup and test of a robotic device to assess motor performance; implementation of algorithms to track limb movements based on images processing and to pre-process and analyse neural signals -
Visiting ScholarUniversity Of Pittsburgh Sep 2014 - Mar 2015Pittsburgh, Stati UnitiVisiting Research Scholar at Mc Gowan Institute for Regenerative Medicine, Department of Physical Medicine and Rehabilitation, University of Pittsburgh.Main Achievements: Experiments on animals by means of robotic device and cell transplantation into injured muscles
Stefano Lai Skills
Stefano Lai Education Details
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Project Management -
Gruppo Midi - Alta FormazioneMedical Devices Regulatory Affairs And Quality Assurance -
Biorobotics -
110/110 Cum Laude (Graduated With Honors) -
110/110 Cum Laude (Graduated With Honors)
Frequently Asked Questions about Stefano Lai
What company does Stefano Lai work for?
Stefano Lai works for Henesis
What is Stefano Lai's role at the current company?
Stefano Lai's current role is Operations and QARA Manager at HENESIS.
What schools did Stefano Lai attend?
Stefano Lai attended Bologna Business School, Gruppo Midi - Alta Formazione, Scuola Superiore Sant'anna, Università Di Pisa, Università Degli Studi Di Cagliari.
What skills is Stefano Lai known for?
Stefano Lai has skills like Matlab, R, Elaborazione Del Segnale, Neuroscienze, Ricerca, Mathematical Modeling, Simulazioni, C, Labwindows/cvi, Sigmaplot, Origin, Signal Processing.
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Stefano Lai
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