Ilona Korczak-Cegielska Email & Phone Number

Warsaw, Pl

Warsaw, Masovian District, Poland

Warsaw, Masovian District, Poland

Clinical Trial Management within the planning and management of clinical trials for medical devices comprising in particular the following areas - I am responsible for:🔹Managing new and ongoing clinical trials (Overall responsibility of the ongoing studies),🔹Conducting feasibility assessment of clinical trial,🔹Managing costs of clinical projects,🔹Leading and managing my team,🔹Mentoring and introducing new team members to the organization,🔹Ensuring compliance of process with the organizations Standard Operating Procedures (SOP),🔹Overseeing the clinical trial documentation, case report form (CRF) designing and clinical investigation plan (CIP) and clinical investigation report (CIR) writing,🔹 Defining plans and action schedules, individually tailored to each type of clinical trials, guaranteeing audit success for the clinical project,🔹Cooperating with Business Partners and Clients,In field of Medical Devices Clinical Investigations.

Warsaw, Masovian District, Poland

R&D Management within the planning and management of Research and Development (R&D) activities and resources, comprising in particular the following areas - I was responsible for:🔹Managing R&D projects (internal and international),🔹Managing costs of projects,🔹Leading and managing the Team,🔹Supervising the implementation of projects into production,🔹Reviewing project deliverables across projects,🔹Preparing of technical documentation and evaluations,🔹Preparing correspondence, reports, presentations and other material as needed for internal and external meetings,🔹Reporting the progress of the project and of the activities to the Management Board (Company CEO),🔹Participating in scientific and industrial conferences and meetings,🔹Cooperation with Business and Industrial Partners,In the field of Medical Devices.

Warsaw, Masovian District, Poland

Medical device design and prototype development in the Research and Development department, comprising in particular the following areas - I was responsible for:🔹Prototyping and production implementation process (new medical devices),🔹Upgrading process (in order to enhance properieties with addidtional functionalities),🔹Consulting process (specifying or designing the best solution),🔹Technical studies (comparative laboratory and validation test),In the following fields: ▪️ cooling devices (kidney cooling device), ▪️ suction equipment (medical suction devices-electrical suction equipment, chest drainage), ▪️ laparoscopic clip appliers with polymer ligating and titanium clips, ▪️ electrosurgery (monopolar and bipolar instruments), ▪️ reusable trocars, ▪️ reusable linear cutting staplers and reusable circular staplers and disposable cartridges, ▪️ advanced deposition techniques for thin film and coating (i.e. ALD, CVD, PVD).

Warsaw, Masovian District, Poland

Warsaw, Masovian District, Poland

🔹Industrial Doctoral Program (Industrial PhD). Research work conducted in field of biomedicine in the Institute of Fundamental Technological Research Polish Academy of Sciences (IPPT PAN).🔹I am the author and co-author of publications, conference papers, monographs in the field of thermal distribution in soft tissues (in particular during kidney transplantation and breast cancer disease) and ultrasound thermal effect enriched by adding micro and nanoparticles to tissue mimicking materials.

Opacz Kolonia, Masovian District, Poland

Extensive interaction with Research and Development department, Quality department and Manufacturing department - I was responsible for taking projects from conception through implementation with particular emphasis in following areas:🔹Designing of medical devices and mechanical development process in NX CAD,🔹Risk analysis reports and Clinical study protocols,🔹Medical device studies. Verification and validation of medical devices,In the field of electrosurgery (monopolar and bipolar instruments).

Cisterna Di Latina, Italy

🔹Main topic of work: Mathematical modeling of growth and mechanics of reconstructed living tissues in COMSOL Multiphysics. 🔹I was working as a part of an international team.

Doctor Of Philosophy (Phd), Biomedical Engineering

The research presented in the doctoral dissertation contributed to obtaining a US patent for the device: Kidney cooling system, No. US.

Postgraduate Studies, Biomaterials - Materials For Medicine

Master'S Degree (Msc), Biomedical Engineering

Engineer'S Degree (Eng.), Biomedical Engineering Spec. Biomechanical Engineering