Director Manufacturing Engineering

Establish and maintain equipment standards for all internal manufacturing operations while developing and leading the preventative maintenance program. Develop and maintain a Class 8 cleanroom environment, evaluate cost savings recommendations, and create communication tools for key business decisions. Lead recurring engineering reviews, manage project budgets and timelines, and provide technical support for design development and sustaining engineering projects. Ensure compliance with FDA Title 21 and ISO standards by reviewing risk management files and overseeing supplier identification for compliant component manufacture. This role directs commercial engineering operations to support rapid growth, continuous improvement, and the company's innovation-driven approach to surgical treatment.