Process Engineer Medical Device

Key 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. #J-18808-Ljbffr Creative Solutions Services, LLC