• Develop and maintain process documentation (assembly procedures, routings, BOMs, process flows, and process FMEAs) while defining and implementing new manufacturing technologies• Define and establish Lean Manufacturing methods, processes, and tools for new products. Establish process controls and opportunities for mistake-proofing.• Optimize, and validate processes and tooling (gauge R&R studies, process capability studies, designs of experiments)• Support prototype, pilot and commercial production of new products, product changes, and enhancements in coordination with the Operations, Product Development and Quality Assurance departaments • Initialize, coordinate and implement Engineering Changes on current process/product design (during product life cycle)• Ensure process compliance with ISO13485, FDA requirements• Tolling setup for stable and repeatable process (such as: ultrasonic welder, laser engraving machine, UV and thermotransfer printers, CNC ploter)• Product labelling design (Afinnity Designer)• Develop, mantain and valid new features in Traceability system

• Engineering support for medical device production departments - solving problems arising during the assembly process• Implement of corrective and preventive actions based on customer notifications (RMA) and current quality problems arising in the process• Participate in NPI processes• Management of production line documentation, preparing material and process flow the flow• Develop and implementat of assembly instructions for production, operator training• Create documentation (BOM, diagrams, technical drawings) for production process tooling• Management of the production process - verification and supervision over the time of production cycles, support for the Production Planning department in determining the efficiency of the line• Participe in MDSAP/ISO/FDA external audits• Value Stream Mapping (VSM) - implement of improvements to eliminate losses in accordance with the Lean methodology, optimize of the production process• Implement PLC configuration and software for Production support system (automatic disinfection system, pressure monitoring on resin dispenser).

• Implementation and development of test systems for mass production of electronic devices• Support for Maintenance Technicians in removing failures• Implementation of an automatic visual inspection system for the verification of AOI/MCP manual assembly components - development of the device concept, design of test sequences• Analysis and modification of machine safety systems - participation in the process of issuing the CE declaration of conformity• Development of technical documentation for testers• Monitoring and improvement of production indicators (FPY, cycle time)• Implementation of new products for testing