INTIMO vision is to become a leading FemTech company with a clear goal to improve women’s health and quality of life through its innovative versatile Intrauterine Device (IUD) as a platform technology for multiple indications, starting with Contraception (IUD) and target Infertility (IUI, slow-release insemination) and Drug-Delivery in the future.

(The Tevadaptor business unit was acquired by FIMI private equity in May 2019 and Simplivia was established)• Managing the R&D department, organic team and external design house, leading new product development (NPD) roadmap from concept to development, regulatory submission and launch.• Managing the Intellectual Property (IP) portfolio in front of patent attorneys including patents maintenance, new patent application, patent prosecution and Freedom to Operate (FTO).• Working closely with board of directors and C-level executives to approve new projects within R&D Investments Committee, present budget & work plan, goals and objectives.• Collaborate with business development and marketing to explore new opportunities for growth, identify the market needs and perform the business case analysis.

• Senior Manager Device Technology at the Global R&D.• Managing the R&D pipeline of Tevadaptor business unit, which specializes in the development and production of CSTD (Closed System Transfer Device) for the safe handling of hazardous drugs.• Managing medical device NPD projects and Life Cycle Management (LCM) projects for Class II devices 510(k) and combination products 505(b)(2).• NextGen development of an electro-mechanical pharmacy compounding system consists of HW, SW / GUI and disposable sterile kit.• Leading R&D project resources by planning & budget control: NRE costs (design, molds & tools), FTE requirements and COGS analysis.• Managing key subcontractors: Med-Tech/Innovation design house, polymers consultant, CROs and external labs, molds makers and tools manufacturers.

Omrix is a Johnson & Johnson company, part of the Biosurgery division within ETHICON, which specializes in the development and production of hemostatic agents / sealants to control intraoperative bleeding:• Senior engineer at the R&D department, specialize in the development of delivery device for combination products (applicators, catheters, mixers etc’) for open & laparoscopic / endoscopic surgery, in the regulatory environment of FDA 21CFR820, CE-Mark, ISO 13485, MDD 93/42/EEC and GMP.• Managing New Product Development (NPD) projects and responsible for Design Control process: Voice of Customer research (VOC), Marketing/Product Requirements Documents (MRD to PRD), Traceability Matrix, Design Reviews, Risk Management (ISO 14971), Verification & Validation testing, Usability Study (Human Factors), Process Validation (IQ/OQ/PQ) and Design History File (DHF) / Tech File.• Leading cross-functional project team from various disciplines such as: R&D, RA, QA, Toxicology, Pre-Clinical, Sterilization, Stability and Packaging.• Technical support for all preclinical studies (in-vitro, ex-vivo, in-vivo).• Experience with Intellectual Property (IP) activities such as: patents search, Invention Disclosure Form (IDF) and working in front of Patent Attorney.• Experience with grant application submission to the Office of the Chief Scientist (OCS).

Tactile Technologies was founded as a start-up company which developed a multidisciplinary navigation system for dental implantology:• Mechanical team leader at the R&D department, leading cross-functional collaboration with electronic & software engineers.• Responsible for development process: concept, prototyping, feasibility tests, product requirements (design inputs), detailed design (2D drawings & 3D models), BOM, specifications, design reviews (PDR/CDR), V&V testing.• Management of external subcontractors for fabrication of prototypes by various technologies such as: 3D printing (SLA, SLS, FDM, Polyjet), silicon molds vacuum casting, CNC machining of metals and plastics, sheet metal, EDM erosion (wire cut / die sinking), laser cutting and coatings.• Participation in clinical trials at Hadassah School of Dental Medicine.

Raval is an industrial company which specializes in the development and production of fuel tank venting systems for the automotive industry:• NPI Project manager at the engineering department in the plastic industry.• Responsibile for New Product Introduction (NPI) process by collaboration with the R&D group from early-stage: design process, design reviews, prototyping, durability & reliability testing, production tools, readiness for pilot production and transition for mass production.• Leading cross-functional project team (R&D, Engineering, Quality, Operation and Marketing) to meet cost, quality and timeline goals.• Management of key subcontractors for fabrication of plastic injection molds and automatic assembly lines.

Medinol is a medical device company which specializes in the development and production of cardio-vascular stents and catheters:• Student at the R&D department within my university final project. The scope of the project deals with design of delivery system for a self-expanding Nitinol stent, intended for treatment of the Carotid artery stenosis.