Develop, optimize, and support manufacturing processes to maximize efficiency and contain total costs of assembly. Generate work instructions, test procedures, ECOs, confirm build quality and coordinate changes for improving manufacturing throughput. Sustain and/or source manufacturing equipment that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety. Execute process and equipment validations (IQ/OQ/PQ). Perform equipment maintenance by following manufacturer’s instructions and established procedures. Provide production line support, including implementing failure analysis and improvements of production processes, troubleshooting equipment, and addressing operator inquiries. Utilize LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement. Represent Manufacturing during design, development and transfer of new medical products to production, including generating of PFMEA. Assist Quality Department with quality system audits, CAPA and NCMR investigations.
BS degree in Mechanical Engineering or equivalent . 3 - 5 years’ experience in manufacture and service of electro-mechanical Class2/3 medical devices. Experience in planning and optimizing manufacturing processes in manufacturing companies. Proficient in using test equipment such as digital voltmeters, oscilloscopes, lab power supplies, etc.. Working knowledge of ERP, MES, PLM systems and Microsoft Office. Basic knowledge of CAD systems (e.g SolidWorks)