Keys: BS Degree, 5+ years of medical device manufacturing, Design Transfer to production, DFM (design for manufacturing), Solidworks, process validation, catheter experience is a big plus
The Sr. Manufacturing Engineer will have high collaboration between R&D, Pilot, and commercial manufacturing and contribute from Early Human Use to the commercialization of new products. The Sr. Manufacturing Engineer will also ensure that design and manufacturing processes are characterized, robust, scalable, utilize best technologies, reflect standard work, are capable and compliant with Regulatory requirements, and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies. The Sr. Advanced Manufacturing Engineer will act as a liaison between R&D, Supplier Development, Quality, and Operations team members assigned to the project.
Developed and optimized efficient, cost-effective, and validated manufacturing processes for medical devices, focusing on capital and/or disposable devices, including assembly, lot release testing, sterilization, and packaging.
Produce production-level assembly and part drawings for all components and sub-assemblies.
Incorporate Design for Manufacturing (DFM), Six Sigma, and LEAN principles into product and process designs to ensure manufacturability, minimize costs, and achieve optimal production efficiency through activities like DFMA reviews and cycle time optimization.
Proactively identify and evaluate potential contract manufacturing partners by analyzing quality, cost, delivery timelines, and regulatory compliance capabilities to recommend optimal providers.
Lead and collaborate with contract manufacturers in selecting and developing the most efficient and reliable manufacturing processes and sites while fostering strong partnerships.
Act as the liaison between Contract Manufacturing Organization (CMO) and Canon to coordinate manufacturing activities as directed by Management.