Dr. Mara Szyrach

Responsible for testing and verification activities for a Blood Gas and Electrolyte (BG/E) analyzer (new development) in an agile framework (SAFe®)

Conduction and oversight of an international, multicentric registry (bioabsorbable vascular scaffold to treat patients with coronary artery disease) according to accepted standards (i.e. ISO 14155, ICH-GCP), international registration requirements and internal procedures

Established and led the department “Pre-Clinical New Products”. Elaboration and conduction of the pre-clinical strategy for the develpment of a transcatheter aortic valve implantation (TAVI) device. Supported the “first in man” & consecutive clinical study as clinicial field specialist, provided the training strategy / gave training to physicians and site personel. As Interim Project Manager, I coordinated the development of a next generation (NG) TAVI heart valve prosthesis.

Lecturer in the Master's program "Biomedical Engineering", RWTH Aachen

Management of pre-clinical & clinical studies in various medical desciplines (endoscopic, laparoscopic interventions in gastroenterology, pulmonology and gynaecology) for medical devices used in cryosurgery, HF-surgery, APC and waterjet-surgery. Fundraising & Project Lead for a third party (BMBF) funded research project. Author of scientific publications, drafting of user brochures and clinical evaluations.

• Managed pre-clinical research projects pertaining to antisense-technology • Drafted and updated project plans • Initiation and management of projects with academic partners • Strategic coordination with internal departments on timelines and costs • Authoring of patent applications and responses to office actions, patent searches • Writing of newsletters, scientific publications and third-party funding applications

Zell-/ Molekularbiologie