The Manufacturing Engineer Contractor will support the design, validation, implementation, and optimization of manufacturing processes and equipment for ophthalmic medical devices used in cataract and vitreoretinal surgeries.
Requirements
- Lead, execute, document, and manage validation activities (IQ/OQ/PQ) to support the introduction or modification of automated and semi-automated production equipment and processes.
- Design, develop, validate, and implement manufacturing processes for ophthalmic medical devices.
- Provide hands-on engineering support for manufacturing equipment before, during, and after release to production.
- Apply Lean Manufacturing and Six Sigma methodologies to optimize production processes.
- Implement Continuous Monitoring using Statistical Process Control (SPC) to maintain equipment and processes in a validated state.
- Perform continuous statistical analysis of Critical Quality Attributes (CQAs) and process indicators to ensure compliance with product specifications (CpK / process capability).
- Design fixtures and create technical drawings using CAD software (e.g., SolidWorks) to support daily production operations.
- Develop and maintain standard work instructions and procedures to ensure robust and high-quality manufacturing processes.
- Promote cross-functional collaboration through clear communication and effective coordination with all departments.
