What are the responsibilities and job description for the Process Engineer Medical Device position at Katalyst Healthcares & Life Sciences?
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.