Director Manufacturing Engineering

Treace; Ponte Vedra Beach (FL); On-site; USD 150,000 - 190,000; Full time

Job summary

Treace is seeking a Director of Manufacturing Engineering to lead commercial engineering operations and establish best practices for supplier and in-house manufacturing compliance. The role requires cross-functional interaction with Product Development, Quality, Marketing and Operations to manage inventory and capacity while supporting growth.

The candidate will implement data analysis tools, drive improvements, and ensure alignment with FDA Title 21 part 820 and ISO standards, enabling robust

Qualifications

• 10+ years of experience in manufacturing / process / quality engineering in a medically regulated environment.
• Bachelor’s degree in related field; MBA preferred.

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.
• Develop and maintain a Class 8 cleanroom manufacturing environment.
• Evaluate and implement cost savings recommendations (process improvements, DFM).
• Create communication tools for easy access to key information to make business decisions.
• Lead recurring Engineering Review 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 Manufacturing Engineering program.
• Provide direction for project management of engineering budgets, timelines, and resources.
• Provide direction and technical support to design development, sustaining engineering and packaging product development.
• Review product and process risk management files to meet FDA and ISO standards.

Skills

Manufacturing engineering

Quality engineering

Process engineering

Education

Bachelor’s degree in related field

MBA preferred

Job description

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. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

POSITION SUMMARY:

The Director of Manufacturing Engineering is responsible for directing the commercial engineering operations business units of the company. The key functions consist of but are not limited to manufacturing equipment selection and installation, equipment validations, special process validations, and product realization documentation / processes both for internal manufacturing and external procurement. The Director of Manufacturing Engineering will establish a strategic and proactive approach to technology possibilities that support the best product development practices and the company's overall growth.

This position will create and implement appropriate data analysis tools necessary for the business units to maintain accurate control of the company's suppliers and manufacturing capabilities in a compliant manner. The position will work with Product Development, Quality, Marketing, Operations, and other cross-functional departments responsible for the management and application of manufacturing (supplier’s and in-house) to support the proper balance of inventory and capacity to ensure there are no supply related business interruptions.

Candidate must possess experience working within an FDA compliant Title 21 section 820 and the ability to work cross-functionally to support rapid growth and continuous improvement. This position will interact with many functions of the business.

PRIMARY DUTIES AND 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.
• With the assistance of Supply Chain, Product Development and Quality, help identify new suppliers as needed for the compliant manufacture of components and finished goods.
• Develop and maintain a Class 8 cleanroom manufacturing environment.
• Evaluate and implement cost savings recommendations (i.e., process improvements, DFM)
• Create communication tools for easy access to key information needed to make business decisions.
• Lead recurring Engineering Review 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 the business strategies.
• Provides direction for project management of engineering project budgets, timelines, and resources.
• Provides direction and technical support to design development projects, sustaining engineering projects and packaging product development.
• Reviews product and process risk management files to meet FDA and ISO standards.

Qualifications

EDUCATION & EXPERIENCE:

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

Additional Information

All your information will be kept confidential according to EEO guidelines.

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer

Treace is a drug free employer.

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