Manufacturing Engineering Manager

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’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 Manufacturing Engineering Manager is accountable for leading and supporting key strategic projects, new product development, and provides manufacturing oversight. This position act as a subject matter expert and will work with Research & Development (R&D), Quality, Marketing, Operations, and other cross-functional departments responsible for the management and application of manufacturing (supplier’s and in-house) to support balance of inventory and capacity to ensure supply continuity for the business.

The Manufacturing Engineering Manager will play a critical role in bridging the gap between R&D and Manufacturing. This role will be responsible for ensuring a seamless design transfer, driving design for manufacturability, and overseeing the biological safety aspects of our medical devices. This position will collaborate cross-functionally with R&D, Quality, Regulatory, and Operations teams.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Manages the Technician team by guiding day-to-day work and operations in Manufacturing
• Provides leadership support, coaching and performance feedback to foster a positive team culture and growth mindset
• Lead design transfer activities from R&D to manufacturing, ensuring smooth hand-off of product designs for production.
• Collaborate with R&D teams to optimize designs for manufacturability (DFM), ensuring efficiency, quality, and cost-effectiveness in production.
• Ensure compliance with biological safety per ISO 10993 standards and regulations, playing an active role in product safety evaluations and validation processes.
• Develop and implement manufacturing processes that meet high standards of quality and efficiency for medical devices.
• Provide technical leadership and guidance to cross-functional teams on manufacturing and process improvement initiatives.
• Identify and resolve manufacturing issues, working hands-on with the production team to drive continuous improvement.
• Support the development of validation protocols (IQ, OQ, PQ) and ensure compliance with regulatory requirements.
• Collaborate with suppliers and external partners to ensure the quality and reliability of components and materials used in the manufacturing process.
• Stay current with industry trends, technologies, and regulations related to medical device manufacturing.
• 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
• Provide SME guidance and mentorship as needed for business functions.

Qualifications

EDUCATION & EXPERIENCE:

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

Additional Information

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