Job DescriptionPOSITION 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.
QualificationsEDUCATION & 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.
