The Industrialization Engineer owns the entire production process lifecycle and product lifecycle, focusing on both New Product Introductions (NPI) and continuous improvements to existing processes. This role is critical in bridging design, development, and production while ensuring scalability and manufacturability. The engineer will collaborate cross-functionally with internal teams (Quality, QC, R&D) and external partners (vendors, suppliers) to optimize processes and improve efficiency. Job Description: + End-to-End Process Ownership: + Manage the entire lifecycle of manufacturing processes—from concept to production to phase-out. + Ensure processes meet quality, cost, and delivery targets across the product lifecycle. + New Product Introduction (NPI) and Continuous Improvement: + Collaborate with R&D and vendors to ensure products are designed for manufacturability and scalability. + Conduct validations and capability studies to confirm new processes meet requirements. + Drive process improvements to increase yield, reduce scrap, and optimize equipment utilization. + Lean Manufacturing & Automation: + Apply Lean principles to minimize waste and improve productivity. + Implement and troubleshoot automated systems to enhance efficiency and consistency. + Integrate mechanical engineering concepts into manufacturing processes. + Change Management and Quality Compliance: + Lead change control processes, including updates to SOPs, manufacturing instructions, and calibration/maintenance procedures. + Work closely with Quality, QC, and external vendors to ensure processes comply with regulatory requirements (e.g., ISO 9001/13485, cGMP). + Investigate manufacturing quality events, develop root cause analyses, and implement corrective actions (CAPA). + Collaboration and Cross-Functional Coordination: + Coordinate with multiple departments—including Supply Chain, Maintenance, and Production—for project success. + Act as the primary liaison with external vendors and suppliers for equipment procurement and process changes. + Participate in cross-site initiatives and provide insights on industrial hygiene practices. + Performance Monitoring and Data-Driven Decision Making: + Track key performance metrics (e.g., OEE, yield, scrap rate) and predict trends for proactive improvements. + Utilize data analytics tools (e.g., Excel, ERP/MES) to generate actionable reports and dashboards. + Training and Knowledge Transfer: + Develop and deliver training sessions for operators and technicians on new or improved processes and technologies. + Mentor junior engineers or team members involved in process improvement initiatives. Minimum Requirements + Bachelor’s Degree required. BS in Mechanical Engineering, Industrial Engineering, or a related discipline is preferred. + 2+ years of experience in a cGMP manufacturing environment. + Proven track record in managing New Product Introduction (NPI) and continuous improvement projects. + Experience working with automated systems, mechanical engineering, and industrial hygiene principles. + Familiarity with Lean manufacturing methodologies and change control processes. Knowledge and Skills + Strong analytical, problem-solving, and project management skills. + Excellent communication and technical writing abilities. + Ability to collaborate effectively with cross-functional and external partners. + Familiarity with MES/ERP systems and data analytics tools is preferred.