Sr. Engineer, Process Development - Wayne, NJ

This role provides technical leadership in the development, optimization, and validation of medical device manufacturing processes, bridging the gap between R&D and commercial production. The incumbent ensures processes are robust, scalable, and compliant with regulatory standards like FDA 21 CFR Part 820 and ISO 13485 while driving successful product introductions. Key duties include leading large-scale process validations, applying Design for Six Sigma tools, and mentoring junior engineers within a cross-functional team.