Manufacturing Engineering Manager – Medical Devices

Treace; Ponte Vedra Beach (FL); On-site; USD 110,000 - 160,000; Full time

Job summary

Treace is seeking a Manufacturing Engineering Manager in Florida to lead and support strategic projects, NPD efforts, and manufacturing oversight for medical devices. The role bridges R&D and Manufacturing, ensuring seamless design transfer, manufacturability, and biocompatibility compliance while coordinating with cross-functional teams.

The ideal candidate has a strong background in mechanical design, 8+ years in manufacturing engineering, and experience in regulated environments.

Qualifications

• Bachelor’s degree in mechanical design or closely related field.
• 8+ years of mechanical design and manufacturing engineering experience.
• Knowledge of design transfer processes and DFM.
• Experience in regulated environments (FDA, ISO 13485) and ISO 14971.
• Lean manufacturing and Six Sigma methodologies.
• Proficiency with Microsoft Office applications.
• Willingness to travel 10–30% for supplier visits and troubleshooting.

Responsibilities

• Manages the Technician team by guiding day-to-day work and operations in Manufacturing.
• Provide leadership, 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 biological safety per ISO 10993 and support product safety evaluations.
• Develop and implement manufacturing processes for quality and efficiency.
• Provide technical leadership to cross-functional teams on process improvement.
• Identify and resolve manufacturing issues with the production team.
• Support validation protocols (IQ, OQ, PQ) and regulatory compliance.
• Collaborate with suppliers to ensure quality and reliability of components.

Skills

Design transfer

DFM

Lean Six Sigma

Manufacturing engineering

Cross-functional leadership

Education

Bachelor’s degree in mechanical design

Tools

Microsoft Office

Job description

Treace is seeking a Manufacturing Engineering Manager in Florida to lead and support strategic projects, NPD efforts, and manufacturing oversight for medical devices. The role bridges R&D and Manufacturing, ensuring seamless design transfer, manufacturability, and biocompatibility compliance while coordinating with cross-functional teams.

The ideal candidate has a strong background in mechanical design, 8+ years in manufacturing engineering, and experience in regulated environments.