Responsibilities:   Lead the development, optimization, and implementation of manufacturing processes.Drive operational excellence, improving product quality, and ensuring efficient production workflows.Design and implement manufacturing processes that improve efficiency, reduce costs, and meet quality standards.Analyze existing workflows and identify opportunities for automation, standardization, and waste reduction.Collaborate with design and R&D teams to ensure manufacturability of new products.Develop test methods and author process validation protocols and reports.Collaborate with engineering to develop, document, and build prototypes, tooling, and fixtures to produce products according to design, quality specifications, and budget.Lead troubleshooting and root cause analysis for process and equipment failures.Plan and manage manufacturing projects, ensuring timely delivery and alignment with organizational goals.Track material lead times, scrap rates, and product delivery schedules.Support product transfer from R&D to pilot production and full production through training and process development.Interact with outside vendors including third-party sterilizers and contract testing labs in order to accomplish project deliverables.Implement cost reductions by working closely with production to reduce scrap and waste and improve efficiencies.   Requirements   Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or a related field.8+ years of experience in manufacturing, process and/or continuous improvement engineering.           Must come from a highly regulated industry such as medical device, pharmaceutical, aerospace, military, etc.Strong knowledge of Lean manufacturing principles and Six Sigma methodologies (certification is a plus).Ability to manage multiple projects and work effectively in a team-oriented environment.Familiarity with statistical process control and metrology.Proficiency in CAD software, ERP systems, and manufacturing tools.