& 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 & Bachelors 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.
