Tuttlingen, Baden-Württemberg, Germany
Development of global harmonized scalable processes for the evaluation of different medical devices in the repair process. Ensuring that global repair sites are enabled to repair and maintenance electronic and electromechanical devices due to company and regulatory standards, as well as ensuring and monitoring compliance with the defined processes. Responsible for ensuring the repairability of newly developed products within the global development process, with particular focus on global scalable evaluation processes as well as determining the repair depth and ensuring the final testing processes in accordance with regulatory requirements, in particular ISO 13485 and 21 CFR 820 (FDA).
Process engineer for process optimization, and design transfer of medical products including the development of new processes, equipment procurement and process optimization as well as the development of manufacturing fixtures, especially for the assembly of optical components and systems. Also responsible for manufacturing transfers from one manufacturing site to another in the US, Poland and Germany.
Process engineer for process optimization, and design transfer of medical class 3 products. Development of new processes, equipment procurement and process optimization as well as the development of manufacturing fixtures.