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

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

Treace's Privacy Policy

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.