Experience

ZygoFix Ltd.

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• CEO

  • Jan 2017 - Present

  Israel Spinal fusion is one of the most common OR procedures performed in the United States, widely using pedicle screws that are invasive and encompass risk of misplacement. Zygofix has developed a uniquely designed miniature implant that achieves spinal fusion and spinal stability without screws. ZygoFix's innovative solution utilizes the natural construction of the spine to achieve optimum stability. Its implant is situated in the facet joints and results in a less invasive and simplified… Show more Spinal fusion is one of the most common OR procedures performed in the United States, widely using pedicle screws that are invasive and encompass risk of misplacement. Zygofix has developed a uniquely designed miniature implant that achieves spinal fusion and spinal stability without screws. ZygoFix's innovative solution utilizes the natural construction of the spine to achieve optimum stability. Its implant is situated in the facet joints and results in a less invasive and simplified procedure. This innovative solution enables the least invasive stabilization: - Requires only one incision per side and 2 in total (compared to 6 used in today's standard systems), - Reduces procedure complexity - no screws are used. - Ability to suit all anatomies - a combination of rigid and flexible enable a perfect fit to every facet joint. www.zygofix.com Show less



Rehabit-Tec Ltd.

• Product Manager

  • Jan 2011 - Dec 2016

  Israel Medical device project manager – managing the development process of a CVA rehabilitation device from idea to it's current status of clinical study. Position tasks include preparation of requirements specification, writing patent, design management, production of 3 beta-site systems and setting for a clinical study.



Qsite

• Vice President

  • Jan 2008 - Dec 2016

  Israel Qsite is a professional, experienced, consulting group focused on the medical device industry. The company's services include advice on international regulatory affairs, clinical affairs, biostatistics and global Quality Assurance (QA). Qsite's experienced team consists of experts in regulatory affairs, product manufacturing and testing, facility inspections, statistics and clinical trial design and evaluation. The scope range varies from a single project (such as a submission) to… Show more Qsite is a professional, experienced, consulting group focused on the medical device industry. The company's services include advice on international regulatory affairs, clinical affairs, biostatistics and global Quality Assurance (QA). Qsite's experienced team consists of experts in regulatory affairs, product manufacturing and testing, facility inspections, statistics and clinical trial design and evaluation. The scope range varies from a single project (such as a submission) to overall outsourcing of the regulatory and quality function. Position includes:  Management of regulatory projects in the medical device field: Actual regulatory and quality manager in several medical device companies as an internal function.  Leading of all CE certification projects performed by the company and escorting the audits.  Writing 510k submissions to the FDA and performing registrations with other regulatory agencies (HC, CFDA, TFDA, MFDS, ANVISA and more).  Supporting the design, writing performance tests, risk analysis and other design supporting documents for a variety of medical devices (Insulin devices, resuscitation devices, aesthetics, ultrasound, implants and more). Show less



Motion Dynamix Ltd.

• Israel
• Automation Machinery Manufacturing
• 1 - 100 Employee

• Project Manager

  • May 2012 - Feb 2014

  Israel Project manager of an airborne satellite tracking unit development, validation and manufacturing. Motion Dynamix is a small and professional engineering group with expertise in unique motion control systems. The project was executed as a subcontractor to a large international company (Panasonic Avionics Corporation) for providing wifi communication on commercial planes. The project included ongoing communications and integration with customer, assuring design complies with its… Show more Project manager of an airborne satellite tracking unit development, validation and manufacturing. Motion Dynamix is a small and professional engineering group with expertise in unique motion control systems. The project was executed as a subcontractor to a large international company (Panasonic Avionics Corporation) for providing wifi communication on commercial planes. The project included ongoing communications and integration with customer, assuring design complies with its requirements, managing suppliers, assembly of prototype units, preparing and performing lab testing against set standards. Show less



CEMEX

• Mexico
• Wholesale Building Materials
• 700 & Above Employee

• Graduate Managment Program, Procurement Planner

  • Jul 2006 - Dec 2007



Qsite

• Mechanical Regulatory

  • Jan 2004 - Jun 2006

  Mechanical regulatory work for different medical devices companies. Writing technical documents: Risk analysis, performance tests etc..