Process Engineer Medical Device

Summary :

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.