The role involves leading manufacturing readiness efforts for new medical device products and catheter sub-assemblies, driving process development, qualification, validation, and continuous improvement initiatives, supporting successful transfer of products and processes from R&D and innovation teams into full-scale manufacturing, managing multiple engineering projects simultaneously, identifying, investigating, and resolving complex manufacturing challenges with innovative and sustainable solutions, leading Lean and Six Sigma improvement efforts focused on quality, efficiency, capacity, and cost optimization, developing and optimizing manufacturing equipment, workflows, line layouts, and test methods, creating and maintaining compliant documentation supporting validations, qualifications, and quality system requirements, acting as a technical leader and mentor to engineers and technicians, collaborating with quality, operations, supply chain, R&D, and leadership teams to achieve business goals, supporting risk assessments, failure investigations, and regulatory compliance activities, and providing technical leadership on cross-functional and multi-site initiatives. A successful Staff Manufacturing Engineer should have a Bachelor's degree in Engineering or another technical discipline, 8+ years of manufacturing engineering experience, preferably within regulated industries, strong experience supporting medical device manufacturing, process development, or new product introduction, demonstrated expertise in Lean Manufacturing, Continuous Improvement, and Six Sigma methodologies, deep knowledge of Quality Systems Regulations (QSR) and/or ISO 13485, experience leading complex engineering projects from concept through implementation, excellent communication, presentation, collaboration, and organizational skills, and ability to influence cross-functional teams and drive results in a fast-paced environment.