About the Role As a Lead Molding & Tooling Engineer, you will serve as the primary technical authority for injection molding processes and complex tooling design. You will drive manufacturing excellence by optimizing production workflows, leading New Product Introduction (NPI) cycles, and ensuring the highest standards of quality for precision plastic components. Responsibilities Architect and refine precision mold tooling designs to maximize production efficiency and part consistency. Lead the end-to-end validation process, including IQ/OQ/PQ, to ensure manufacturing systems meet rigorous performance benchmarks. Drive continuous improvement initiatives by conducting root cause analysis and implementing advanced process control strategies. Provide expert technical oversight for mold maintenance, equipment troubleshooting, and automation performance. Collaborate with cross-functional teams to streamline production throughput and reduce defect rates through data-driven process optimization. Manage capital investment projects, including the evaluation of emerging tooling technologies and the creation of technical justifications. Mentor engineering staff on best practices in scientific molding, process development, and regulatory compliance. Qualifications Required Skills Bachelor's degree in Engineering or equivalent professional experience. Minimum of 5 years of experience in injection molding and tooling engineering. Demonstrated expertise in process validation (IQ/OQ/PQ) and capability studies. Strong proficiency in troubleshooting industrial automation and molding equipment. Ability to maintain GxP compliance and rigorous documentation standards. Preferred Skills Degree in Plastics or Mechanical Engineering. Deep understanding of scientific molding principles and hot runner systems. Experience in medical device manufacturing or highly regulated industries. Proficiency with process monitoring systems and dimensional inspection techniques. Hands-on experience with end-of-arm tooling (EOA) and robotic integration.