Process Engineer � Medical Device

SummaryKey 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. Education & Experience 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.