Manufacturing Engineering Manager

About the role

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. The Manufacturing Engineering Manager is accountable for leading and supporting key strategic projects, new product development, and provides manufacturing oversight. This position acts 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 role plays a critical part in bridging the gap between R&D and Manufacturing, ensuring seamless design transfer, driving design for manufacturability, and overseeing the biological safety aspects of medical devices.

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.
• Leads design transfer activities from R&D to manufacturing, ensuring smooth hand-off of product designs for production.
• Collaborates with R&D teams to optimize designs for manufacturability (DFM), ensuring efficiency, quality, and cost-effectiveness in production.
• Ensures compliance with biological safety per ISO 10993 standards and regulations, playing an active role in product safety evaluations and validation processes.
• Develops and implements manufacturing processes that meet high standards of quality and efficiency for medical devices.
• Provides technical leadership and guidance to cross-functional teams on manufacturing and process improvement initiatives.
• Identifies and resolves manufacturing issues, working hands-on with the production team to drive continuous improvement.
• Supports the development of validation protocols (IQ, OQ, PQ) and ensures compliance with regulatory requirements.
• Collaborates with suppliers and external partners to ensure the quality and reliability of components and materials used in the manufacturing process.
• Stays current with industry trends, technologies, and regulations related to medical device manufacturing.
• Assists Supply Chain, Product Development, and Quality in identifying new suppliers as needed for the compliant manufacture of components and finished goods.
• Provides SME guidance and mentorship as needed for business functions.

Requirements

• 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 and 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.