Director Manufacturing Engineering

About the Company

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct and intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. Our products and services assist foot and ankle surgeons in improving patient outcomes, reducing healthcare costs, and providing rewarding experiences for employees and stakeholders.

About the Role

The Director of Manufacturing Engineering is responsible for directing the commercial engineering operations business units of the company. Key functions include manufacturing equipment selection and installation, equipment validations, special process validations, and product realization documentation for both internal manufacturing and external procurement. This role establishes a strategic and proactive approach to technology possibilities that support product development and company growth. The position creates and implements data analysis tools to maintain accurate control of suppliers and manufacturing capabilities in a compliant manner.

This role works cross-functionally with Product Development, Quality, Marketing, Operations, and other departments to balance inventory and capacity, ensuring no supply-related business interruptions. The candidate must have experience working within an FDA-compliant Title 21 section 820 environment and support rapid growth and continuous improvement.

Responsibilities

• Establish and maintain equipment standards for all internal manufacturing operations.
• Develop and lead the Preventative Maintenance program and reliability efforts for internal manufacturing operations.
• Identify new suppliers as needed for compliant manufacture of components and finished goods, in collaboration with Supply Chain, Product Development, and Quality teams.
• Develop and maintain a Class 8 cleanroom manufacturing environment.
• Evaluate and implement cost-saving recommendations, such as process improvements and Design for Manufacturing (DFM).
• Create communication tools for easy access to key business decision-making information.
• Lead recurring Engineering Reviews with key team members.
• Ensure compliance with the company quality system as it relates to Manufacturing Engineering.
• Provide direction for the maintenance and management of an effective, efficient Manufacturing Engineering program to support business strategies.
• Direct project management of engineering project budgets, timelines, and resources.
• Provide technical support to design development projects, sustaining engineering projects, and packaging product development.
• Review product and process risk management files to meet FDA and ISO standards.

Requirements

• 10+ years of experience in manufacturing, process, or quality engineering in a medically regulated and technical environment.
• Bachelor’s degree in a related field required (preferably Engineering or Science); MBA preferred.
• Experience working within an FDA-compliant Title 21 section 820 environment.