Sr. Engineer, Process Development - Wayne, NJ

This role provides technical leadership in the development, optimization, and validation of medical device manufacturing processes, ensuring robustness and compliance with regulatory standards like FDA and ISO. The position involves leading design transfer activities from R&D to commercial production, driving continuous improvement through Lean and Six Sigma methodologies, and mentoring junior engineers. It requires cross-functional collaboration to support product launches and ensure manufacturability while managing risk and audit readiness.