Director of Process Development

Job description

Director of Process Development to lead the development, optimization, and scale-up of manufacturing processes for advanced catheter-based and electromechanical medical devices. This role will provide strategic and hands-on leadership across cross-functional teams to ensure robust, compliant, and cost-effective processes from early development through commercialization. The ideal candidate brings deep technical expertise in medical device process development, strong people leadership, and a proven track record of driving manufacturing readiness in regulated environments. Key Responsibilities: · Provide strategic and operational leadership for process development activities supporting catheter-based and electromechanical devices · Lead, mentor, and develop a high-performing team of engineers and technical professionals · Drive process development from concept through pilot, validation, and commercial scale manufacturing · Partner closely with R&D, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure seamless product transfer · Establish and improve process development methodologies, tools, and best practices · Oversee design for manufacturability (DFM), design for as...