What are the responsibilities and job description for the Manufacturing Engineer-Medical Device position at Intellectt Inc?
The ideal candidate possesses both a high level of technical expertise and an innate passion to build. You will play a critical role in creating and refining processes in order to improve manufacturing safety, quality, and productivity.
Responsibilities:
- Operational Qualification Assessments (Weight: 20%)
- Develop and prepare operational qualification assessments to ensure validated critical operating parameters are maintained within qualified parameters.
- Validation Protocol Development and Execution (Weight: 20%)
- Generate and execute validation protocols including:
- Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), Test Qualification Formulation (TQF)
- Process Characterization and Process Validation aligned with equipment capabilities.
- Process Equipment Qualification Studies (Weight: 15%)
- Conduct installation, operational, and performance qualification studies to verify the functionality of process equipment.
- Support for New Product Introduction (NPI) and Process Transfers (Weight: 5%)
- Assist in new product introductions and process transfer activities while adhering to regulatory requirements in a manufacturing environment.
- Perform other duties as assigned to support team goals and objectives.
- Education: Bachelor’s degree in Engineering or a related technical discipline.
- Experience: Experience in equipment qualification, process validation, and regulated manufacturing environments.
- Strong knowledge of validation protocols and industry standards
