Gil Senesh Email & Phone Number

Misgav Regional Council, North District, Israel

A startup company developing a novel non-invasive, immediate and inclusive therapy to cope with fecal incontinence, improve patients wellbeing and restore quality of life.

Ceaseria, Israel

Leading innovation team developing the next generation of heart failure therapies

Irvine, California, United States (Relocation)

Drive the development of Transcatheter Aortic Valve (TAVI) System: Implant, delivery system, crimping device, pre-procedural planning, prep and procedure.Lead cross functional team leaders through strategic discussions, prioritization, technical risks and mitigation plans towards First-in-Human experience, pivotal study and other major program milestones.Drive consensus and technical actions across all functions and levels.Navigate quickly and effectively through uncertainties and technical challengesPromote technical investigations, root-cause-analyses, research work and MFG improvementsOversee the interaction between different aspects of the system (Crimper - Valve – DS – Sheath)Synergize clinical data and bench data to optimize design and procedureWork with KOL to refine system requirements and validate performances

Israel

Lead the development of Trancatether Heart Valve Implant (TAVI), through design, MFG, testing, final element analyses towards design freeze and transition to the US.Directed cross-functional teams within the organization (Israel and US) to support program needs and readiness for transfer Guided multi-disciplinary team of engineers and technicians through investigations, engineering studies, root-cause-analyses and failure analyses Presented to leadership and stakeholders project status and needsDefined project scope, timelines and resources

Mannheim Area, Germany (Relocation)

Promote know-how transfer and R&D integration for a project originated from Israel. Consult regulatory, system, R&D and verification aspects. Lead engineering studies, R&D lab activities and data analyses.

Managing a team of biomedical engineers and lab technicians responsible for developing, designing and conducting of multi-disciplinary studies (mechanical - electronic - software - materials - chemistry) for research & development, integration and system verification purposes of medical devices.Leading verification projects for FDA/CE submissions.

Development of a biosensor based on electrochemical-nano materials technology project.Transfer technology from Research (Academy) to Development, including: studing the field and technology from scratch, establishing an in-house laboratory, desiging and conducting feasability and development studies, recrutting and managing lab engineers.

Research & development in the field of mechanical - material interactions in multi-disciplinary medical device involving drug (combined product):literature surveys, material selection, design of exepriements, develop work methodologies, defining specifications and conducting verification studies.Work included close interaction with sub-contractors, consultants, animal and analytical labs in israel and abroad.

Conducting literature surveys and feasibility studies to assess the possibility of using existing technologies for the medical device / pharma industries

Bsc, Biomedical Engineering, Cum Laude

Mba, Marketing, Excellency

Activities and Societies: Participated in the UC-San Diego program for Entrepreneurship