Manufacturing Engineering Manager

Position Summary: The Manufacturing Engineering Manager leads the Manufacturing Engineering team in the development, management, and continuous improvement of the manufacturing lines, equipment, processes, and training on the production floor. As the owner of how manufacturing at Cadwell is done this key role oversees a team of skilled Manufacturing engineers that ensure production is able to meet Cadwell’s growing business demands. This leader supports both their technical development, as well as identifies, plans, and guides their work to optimize production efficiency, quality, and consistency. Key Duties / Responsibilities: Oversees and leads the creation, maintenance, and continuous improvement of the manufacturing systems (processes, equipment, training, etc.) used to manufacture Cadwell’s medical devices, both for existing and new designs Oversees and leads the specification, development, and maintenance of production line test methods, processes, and fixtures; ensures that the approach to testing scales to meet Cadwell’s growing business needs Develop, maintain and track capital equipment budget for needed manufacturing investments Actively monitors the manufacturing industry for state of the art in these areas to ensure Cadwell’s production environment is robust, efficient, and scalable Ensure the team, process, and systems align with applicable regulations (FDA 21 CFR Part 820, ISO 13485, 2017/745/EU Medical Device Regulation); supports internal and external audits from FDA and Notified Bodies Oversees and leads the development and continuous improvement of Cadwell's equipment calibration program, defining the appropriate strategy for in-house versus outsourced calibration; ensures program efficiency, compliance, and scalability. Partners with other departments such as R&D, Supplier Quality, IT, Production, Regulatory Affairs, and Quality Assurance to ensure smooth design transfers and efficient day-to-day operation of the production environment Oversees and leads the Manufacturing Engineering team through the NPI and design transfer processes; ensures that designs and their manufacturing processes are robust and repeatable Provides mentorship and guidance to the Manufacturing Engineering team, assisting in their development and strategically growing and diversifying their skillset to best support Cadwell’s success Perform other duties as assigned Job Knowledge / Requirements: Comprehensive knowledge of Process Engineering and Optimization to improve efficiency, utilization, throughput and yield Comprehensive knowledge of the device manufacturing environment and problem solving within its unique technical, regulatory, and operational challenges Thorough knowledge and experience with change control processes and activities Thorough knowledge of design-for-manufacture concepts and practical application thereof during the engineering development process Thorough knowledge of the Manufacturing Engineering discipline as it applies to NPI, including production line setup, test procedure development, and measurement of manufacturing system performance against defined acceptance criteria Thorough knowledge of New Product Introduction (NPI) and the design lifecycle, with hands on experience in leading programs through each phase - from engineering development through manufacturing validation, production release, and the ongoing manufacturing support of active designs Thorough knowledge of Continuous Improvement processes (i.e. Lean Manufacturing - Six Sigma, Kaizen, 5S, etc.) Thorough knowledge of Automation and Technology Integration; experience with practical applications of technologies and smart manufacturing integration to increase quality and reduce rework. Demonstrated ability to create/manage a vision and think strategically, plan and organize, innovate, analyze complex data and situations, and exercise sound judgment; able to communicate that vision, motivate and lead employees, and collaborate with other teams Demo…