Process Engineer

Responsibilities :Design, develop, and optimize manufacturing processes for medical devices.Execute Design of Experiments (DOE) to improve process performance.Perform process characterization and statistical analysis (e.g., using MINITAB).Collaborate with cross-functional teams including Engineering, Quality, and Operations.Support process documentation for regulatory compliance (FDA, ISO 13485).Identify process improvements and implement corrective actions.Strong knowledge of process engineering principles in a medical device environment.DOE and statistical analysis experience (MINITAB or similar tools).Familiarity with process validation and qualification.Understanding of regulatory standards: FDA, ISO 13485, GMP.Excellent problem-solving, communication, and collaboration skills.Requirements:Previous experience in process optimization and continuous improvement in a regulated environment.Experience with manufacturing equipment selection, setup, and troubleshooting.Knowledge of lean manufacturing and Six Sigma methods.