Reporting to the Senior Director of Operations, the Manufacturing Manager is responsible for production, process improvement, materials operations, and the growth of the manufacturing team, ensuring products are manufactured in compliance with FDA QMSR (21 CFR Part 820), cGMP, and ISO 13485:2016. This role partners closely with R&D, Quality, Supply Chain, and external suppliers to support new product introduction, strengthen operational readiness, and improve efficiency, yield, and quality over time.