. Lead the development of the manufacturing process for PCBA/Mechatronics medical products to be insourced to the plant. ACCOUNTABILITIES: Lead the process development & process improvements for the manufacturing of existing and new PCBA/Mechatronics assembled products, developing assembly processes and product testers with their corresponding capacity, statistical capability, ergonomics and PFMEA analysis. Improve labor efficiency, product quality, reducing WIP / scrap / ergonomics risks and overall manufacturing costs by incorporating Lean/Six Sigma concepts to reduce waste and optimize manufacturing processes, analyzing OEE, bottle necks, designing and creating alternative layouts, balancing lines, leading KAIZEN events and process flow improvements. Support the DFM/DFA and PFMEA process on new products to be insource to the plant being a link between R&D and manufacturing, seeking for failure modes elimination or risks reduction from the product design and / or process controls POKAYOKE. Define and execute the required manufacturing process validations (FAT, IQ, CSV, TMV, OQ, PQ) for launching new products meeting plant QMS, ISO13485 standard, FDA requirements, and other applicable regulations. Support production ramp up plan after validation phase is completed, driving the resolution of any potential issue thru root cause corrective actions process and performing the lessons learned transfer as preventive activities. Implement the required process adequations from product/process/material changes or other new requirements/changes using statistical tools like GRR/ DOE/ SPC. Perform complex product FA root cause analysis utilizing technical knowledge on various testing equipment, electrical drawings, SW testing protocols and mechanical specifications. Develop and maintain ESD/manufacturing controls procedures. Develop robust solutions to complex operational, process, quality/safety issues (QNC/CAPAS) as part of the sustaining process using strong root cause corrective actions methodologies like 8Ds. Design, implement and maintain current/new manufacturing systems. Support multiple projects, multiple deadlines, assuring schedules are defined and met, prioritizing work appropriately to meet commitments following quality system procedures and plant policies. Develop, publish, communicate, and maintain procedures, work instructions, forms, layouts, and process maps which allow consistent execution of required processes. Performs financial justification of new equipment and tooling, designing jigs and fixtures / 3D Printing to meet production requirements. Utilizes the SAP ERP and ETQ systems to review/update relevant manufacturing information such as production rates. 15