Process Engineer

We are seeking a motivated Process Engineer with 2+ years of experience in medical device manufacturing to support manufacturing operations, process improvements, and production efficiency initiatives in a regulated environment. The ideal candidate will have hands‑on experience with manufacturing processes, troubleshooting, validations, and cross‑functional collaboration within FDA/ISO regulated industries. Key Responsibilities Support day‑to‑day manufacturing operations and resolve process‑related issues on the production floor Drive continuous improvement initiatives to enhance product quality, yield, and operational efficiency Assist with process development, optimization, and implementation activities Perform root cause analysis and support CAPA investigations for manufacturing issues Develop and update process documentation including SOPs, work instructions, and manufacturing procedures Support equipment qualifications and process validations (IQ/OQ/PQ) Collaborate with Manufacturing, Quality, Validation, and Engineering teams to ensure smooth production activities Monitor process performance and analyze manufacturing data to identify trends and improvement opportunities Participate in non‑conformance investigations and implement corrective actions Ensure compliance with FDA, GMP, ISO 13485, and company quality standards Required Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related technical field 2+ years of experience in medical device manufacturing or regulated manufacturing environments Experience supporting manufacturing processes and process improvement activities Knowledge of GMP, FDA regulations, and ISO 13485 requirements Familiarity with process validation activities (IQ/OQ/PQ) Experience with root cause analysis, CAPA, and non‑conformance investigations Strong problem‑solving and analytical skills Excellent communication and cross‑functional collaboration abilities Preferred Qualifications Experience with Lean Manufacturing or Six Sigma methodologies Hands‑on experience working in cleanroom or regulated production environments Familiarity with manufacturing equipment troubleshooting and process optimization Experience using statistical tools such as Minitab or Excel for data analysis #J-18808-Ljbffr Intellectt Inc