Experience

ALTHEA MEDICAL LTD

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Co-Founder and CEO

  • Dec 2020 - Present

  Althea Medical is developing a unique catheter-based solution to treat patients suffering from massive or sub-massive Pulmonary Embolism. The company is part of Peregrine Ventures' Incentive portfolio. Althea Medical is developing a unique catheter-based solution to treat patients suffering from massive or sub-massive Pulmonary Embolism. The company is part of Peregrine Ventures' Incentive portfolio.



Edwards Lifesciences

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Associate Manager of Regulatory Affairs

  • Apr 2017 - Dec 2020

  - Taking part in EFS and NOCs submissions. - Regulatory impact determination of engineering changes in clinical and commercial phases. - Standards management for commercial product. - July 2019 - Relocation to Edwards R&D Center in Caesarea, responsible for requirements and Risk Management of projects in R&D phase (Design Assurance). - Taking part in EFS and NOCs submissions. - Regulatory impact determination of engineering changes in clinical and commercial phases. - Standards management for commercial product. - July 2019 - Relocation to Edwards R&D Center in Caesarea, responsible for requirements and Risk Management of projects in R&D phase (Design Assurance).



Valtech Cardio

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• System Engineer, Cardioband R&D

  • Nov 2014 - Mar 2017

  Leading the planning and execution of Cardioband DV testing for IDE submission, including biocompatibility, in vivo studies and bench testing. Valtech Cardio was acquired by Edwards Lifesciences in January 2017. Leading the planning and execution of Cardioband DV testing for IDE submission, including biocompatibility, in vivo studies and bench testing. Valtech Cardio was acquired by Edwards Lifesciences in January 2017.



Endospan Ltd.

• Israel
• Medical Device
• 1 - 100 Employee

• QA Manager

  • May 2012 - Oct 2014

  • Managing QA/QC team. • Authoring and implementation of ISO 13485 procedures. Leading the company to its first and successful ISO 13485 audit. • Responsible for Design Control implementation (including design transfer) and DHF. • Responsible for Manufacturing QC processes. • Managing QA/QC team. • Authoring and implementation of ISO 13485 procedures. Leading the company to its first and successful ISO 13485 audit. • Responsible for Design Control implementation (including design transfer) and DHF. • Responsible for Manufacturing QC processes.



IVT Medical Ltd.

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Technical Project Manager

  • Nov 2009 - Apr 2012

  Technical management of projects in the field of wound healing: • A commercially available skin stretching and wound secure closure device (TopClosure) • A device combining software, electronics and mechanics (Vcare) - wound healing device applying regulated negative pressure-assisted wound treatment (RNPT) to enhance healing of complex and hard to heal wounds. Technical management of projects in the field of wound healing: • A commercially available skin stretching and wound secure closure device (TopClosure) • A device combining software, electronics and mechanics (Vcare) - wound healing device applying regulated negative pressure-assisted wound treatment (RNPT) to enhance healing of complex and hard to heal wounds.



Tel Aviv University

• Israel
• Higher Education
• 700 & Above Employee

• Teaching Assistant

  • Oct 2007 - Oct 2009

  Teaching assistant for graduate courses in Bio-Medical Engineering: • Introduction to Bio-Materials • Cell Biology Teaching assistant for graduate courses in Bio-Medical Engineering: • Introduction to Bio-Materials • Cell Biology



BVR Systems

• QA and Implementation team leader

  • Oct 2000 - Oct 2002

  Managing a team of 8 members, working on several projects simultaneously, in Israel and abroad.

• QA and implementation

  • Jan 2000 - Sep 2000

  QA and Implementation of Air Combat Debriefing Systems:• Designing and performing functional software and system tests.• System installation, technical support and instruction to local and international customers (including combat pilots),