Process Engineer Medical Device

Process Engineer Medical Device Katalyst Healthcares & Life Sciences - 4.0 Tonawanda, NY Job Details Contract 1 day ago Qualifications ISO standards Quality control statistical data analysis Design of manufacturing processes Regulatory compliance Six Sigma methodology implementation Engineering process optimization GMP Mid-level Industrial equipment troubleshooting Minitab Continuous improvement Experimental design Cross-functional collaboration Communication skills Implementing lean manufacturing processes Cross-functional communication FDA regulations Statistical analysis tools Engineering validation

Full Job Description 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.