Experience

LSI Industries Ltd.

• Israel
• Medical Device
• 1 - 100 Employee

• CEO & Co-Founder

  • Oct 2019 - Present

  LSI Industries was founded at the end of 2019 and offers a full range of engineering & clean room services, including but not limited to: ☑️ Clean room services (rooms & stations for rent) ☑️ Logistic and operational support ☑️ Process development. ☑️Process documentation ☑️ NPI support ☑️ Plastic mold DFM and injection support ☑️ Tooling design and manufacturing ☑️ V&V activity support Clean room consists of: ▶️ Room #1 - ISO 7 Class 10,000 – 26 m² 6 work stations ▶️ Room #2 - ISO 7 Class 10,000 – 30 m² 8 work stations ▶️ Washing room ISO 8, Class 100,000 – 6 m². LSI Industries offers over 15 years engineering experience form various companies, from small start-ups to global enterprises. We offer engineering services to Medical Device companies from the development stages to large scale production lines. Services include but are not limited to: ☑️ New Product Introduction (NPI) ☑️ DHR development ☑️ Tooling design capability ☑️ Design verification & process validation The company is in the process of obtaining ISO:13485:2016. We are compliant with the following: Current Good Manufacturing Practice (CGMP) FDA CFR21 part 820 Continuous improvement of products & processes Management Control QC – incoming, out-going capabilities We look forward to working with you - please Email or call us on: 054-999-2009 Kobi@l-s-i.co.il Show less



V-Wave

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Manufacturing Director

  • Mar 2016 - Oct 2019

  Establishment and management of the operational operations array; Including management and planning of the supply and production chain, negotiations with suppliers and subcontractors. Implementation of the ERP : Procurement, product trees, QC, warehouse management, including warehouse subcontractors. • Establishment of production lines; In accordance with the requirements of the FDA and ISO 13485, fully implement the production quality requirements (QC, MRB) and cleanroom work. • Transition from development to production; Supporting all V & V activities, building product trees, implementing work instructions, making the required adjustments to increase production requirements, establishing a distribution infrastructure for an extensive clinical trial. • Characterization, assimilation and management of the IT system; Including the company's IT infrastructure in the US. • Responsible for management: operations site, production team, including weekly production planning, supply chain, warehouse, import-export, IT. Show less



Motorika - Robotic Rehabilitation Solutions

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Operations Manager

  • Mar 2015 - Feb 2016

  Responsible for the entire company operation through the management of procurement ,ERP infrastructure that controls all supply chain from budget to outgoing PO, customers’ orders, field returns, inventory management and shipments deliveries. Managing subcontractors, negotiations on medium to large scale manufacturing series and significant R&D expenses. Iplemented ERP Priority system in the group, Infrastructure & management Production lines. BOM control, Implemented MRP . QA oriented supports FDA & CE procedures in manufacturing process. Show less



MediGuide

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Purchasing & Logistics Manager

  • Jun 2008 - Mar 2015

  Responsible for all operations infrastructure and management: full ERP characterization and instalation, infrastructure for purchasing, production and logistics management,cost reduction characterization and management ,impot, export, building maintanace subcontractores management. Responsible for all operations infrastructure and management: full ERP characterization and instalation, infrastructure for purchasing, production and logistics management,cost reduction characterization and management ,impot, export, building maintanace subcontractores management.



UltraShape

• Purchasing Manager

  • Mar 2006 - Jun 2008

  Responsible for assimilation of the purchasing and logistics at ultrashape. Purchase and logistics processes at the ERP system. MRP assimilation and managment. Cost reduction management. Responsible for assimilation of the purchasing and logistics at ultrashape. Purchase and logistics processes at the ERP system. MRP assimilation and managment. Cost reduction management.