Engineering Manager

·  Establish and support a work environment of continuous improvement that supports Endosense’s Quality Policy, Quality System as well as Safety and Environment regulations, in accordance with both ISO 13485 and QSR 21 CFR 820 requirements

·  Hire, maintain and retain Engineering team members, including process Engineers, Technicians and other appropriate positions to support the development of the Engineering activities

·  Ensure employees are trained to do their work and their training records are properly documented

·  Provide appropriate data to support the Operations Business Plan

·  Maintain the production facility, identifying and selecting the technologies as well as the machines required to run the operations according to Business plan

• Lead value improvement projects. Continually seek to drive / improvements in process design, layout and operational performance, working closely with R&D and Quality

·  Manage and conduct manufacturing processes validation in accordance with both ISO 13485 and QSR 21 CFR 820 requirements, including equipment qualifications (IQ/OQ/PQ)

• Actively promote and participate in a cross-functional teamwork environment
• Assist in the analysis, development and implementation of preventive actions which proactively resolve product, process and systems issues

·  Ensure that Manufacturing documentation is accurate, complete and organized,  in close collaboration with the Manufacturing and Supply Chain Manager, as well as according to the internal Quality Management

• Ensure the ERP system is fully operational within the Manufacturing and Supply Chain department, drive continuous improvements of its use within the company, in close collaboration with the Manufacturing and Supply Chain Manager
• Accountable for the setup/maintenance of the BOM’s and Manufacturing steps in the ERP system 
• Provide reporting to the Top management of the Key Indicators related the Engineering department on a regular basis