Parthasarathi T

Lead Silicone Extrusion Project Engineer Project Manager @Cirtec Medical

Sturtevant, WI, US

Leading the full-scale technology transfer of silicone extrusion manufacturing lines from an external facility to Cirtec Medical, establishing a new production platform for Class II & medical devices. • Driving end-to-end manufacturing setup, including creation of part numbers, BOM structures, product drawings, specifications, and inventory controls, ensuring seamless integration into Cirtec’s ERP and quality systems. • Overseeing cleanroom 7 & 8 equipment qualifications (IQ/OQ/PQ) and validation of extrusion and downstream processes in compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements. • Collaborating cross-functionally with Quality, Manufacturing, R&D, and Supply Chain to align documentation, material flow, and process parameters with customer and regulatory expectations. • Developing and standardizing engineering documentation—including Work Instructions (WI), Sample Request Forms (SRF), CTQ matrices, and process flow diagrams—based on lessons learned and customer feedback. • Leading DMAIC-based RCA and CAPA investigations to address nonconformities, improve process stability, and reduce startup scrap. • Managing all project management activities: defining timelines, allocating resources, tracking milestones, and driving cross-site communication to achieve on-time validation and production readiness. • Converting legacy technical files and validation data into Cirtec’s document control systems to ensure complete traceability and efficient change control.