Manufacturing Engineering Manager — Medical Devices & DFM

Treace Medical Concepts, Inc.; Ponte Vedra Beach (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Treace Medical Concepts, Inc. in Ponte Vedra Beach, FL, seeks a Manufacturing Engineering Manager to lead strategic projects, drive NPD efforts, and oversee manufacturing for our bunion care devices.

You will bridge R&D and Manufacturing, own design transfer, ensure DFM, support regulatory and quality teams, and mentor cross-functional staff while ensuring supply continuity. The role requires strong leadership, hands-on problem solving, and collaboration with suppliers to maintain high-quality

Qualifications

• Bachelor’s degree in mechanical design or closely related field.
• 8+ years of relevant mechanical design and manufacturing engineering experience.
• Strong knowledge of design transfer processes and design for manufacturability (DFM).
• Experience in a regulated environment (FDA, ISO 13485), ISO 14971, and ISO 10993 biological safety.
• Knowledge of Lean Manufacturing principles and Six Sigma methodologies.
• Experience with Microsoft Word, Excel, Outlook.
• Willing to travel 10-30% of the time for supplier visits and troubleshooting.

Responsibilities

• Manages the Technician team by guiding day-to-day work and operations in Manufacturing.
• Provides leadership support, coaching and performance feedback to foster growth.
• Lead design transfer activities from R&D to manufacturing for production.
• Collaborate with R&D to optimize designs for manufacturability (DFM).
• Ensure compliance with biological safety ISO 10993 standards and regulations.
• Develop and implement manufacturing processes that meet high standards of quality.
• Provide technical leadership to cross-functional teams on process improvement.
• Identify and resolve manufacturing issues with production teams.
• Support validation protocols (IQ, OQ, PQ) and regulatory compliance.
• Collaborate with suppliers to ensure quality and reliability of components.
• Stay current with industry trends, technologies, and regulations.
• Assist Supply Chain and Quality to identify new suppliers for compliant manufacture.
• Provide SME guidance and mentorship as needed.

Skills

Mechanical design

Manufacturing engineering

Design transfer

DFM

Lean manufacturing

Six Sigma

Regulatory compliance

Microsoft Office

Travel willingness

Education

Bachelor's degree in mechanical design or closely related field

Job description

Treace Medical Concepts, Inc. in Ponte Vedra Beach, FL, seeks a Manufacturing Engineering Manager to lead strategic projects, drive NPD efforts, and oversee manufacturing for our bunion care devices.

You will bridge R&D and Manufacturing, own design transfer, ensure DFM, support regulatory and quality teams, and mentor cross-functional staff while ensuring supply continuity. The role requires strong leadership, hands-on problem solving, and collaboration with suppliers to maintain high-quality