Director, Manufacturing Engineering & Compliance

Treace Medical Concepts, Inc.; Ponte Vedra Beach (FL); On-site; USD 130,000 - 190,000; Full time

Job summary

Treace Medical Concepts, Inc. seeks a Director of Manufacturing Engineering to lead commercial engineering operations and drive manufacturing strategy.

The role focuses on equipment selection/validation, process validation, and product realization for internal manufacturing and suppliers. The candidate will implement data tools to manage suppliers and manufacturing capacity while ensuring FDA Title 21 CFR 820 compliance.

Qualifications

• 10+ years of experience in manufacturing / process / quality engineering in a medically regulated and technical environment.
• Bachelor’s degree in related field required (preferably Engineering or Science related); MBA preferred.

Responsibilities

• Establish and maintain equipment standards for all internal manufacturing operations.
• Develop and lead the Preventative Maintenance program and lead all Reliability efforts for internal manufacturing operations.
• Identify new suppliers as needed for compliant manufacture of components and finished goods.
• Develop and maintain a Class 8 cleanroom manufacturing environment.
• Evaluate and implement cost savings recommendations (e.g., process improvements, DFM).
• Provide direction for project management of engineering project budgets, timelines, and resources.

Skills

Manufacturing engineering

Process engineering

Quality engineering

Education

Bachelor’s degree in related field

MBA preferred

Job description

Treace Medical Concepts, Inc. seeks a Director of Manufacturing Engineering to lead commercial engineering operations and drive manufacturing strategy.

The role focuses on equipment selection/validation, process validation, and product realization for internal manufacturing and suppliers. The candidate will implement data tools to manage suppliers and manufacturing capacity while ensuring FDA Title 21 CFR 820 compliance.