Our client in Houston, Texas is seeking 3 Manufacturing Engineer Contractors. The contractors will be responsible for leading, executing, documenting, and managing validation activities (IQ/OQ/PQ) necessary to support the introduction or revision of automated and semi-automated production equipment and processes for ophthalmic medical devices.
Key Responsibilities:
- Lead, execute, document, and manage validation activities (IQ/OQ/PQ) for automated and semi-automated production equipment and processes.
- Design, develop, validate, and implement manufacturing processes for building ophthalmic medical devices for cataract and vitreoretinal surgeries.
- Support production process optimization through Lean and Six Sigma methodologies.
- Apply concepts of Continuous Monitoring through Statistical Process Control (SPC) to ensure processes are monitored and controlled appropriately, maintaining equipment in a validated state.
- Conduct continuous statistical analysis of Critical Quality Attributes and Indicators to ensure existing processes meet product specifications (CpK/Process Capability).
- Provide hands-on support for manufacturing equipment before, during, and after release to production.
- Design fixtures and create drawings in CAD software (e.g., SolidWorks) to support production in day-to-day operations.
- Promote cooperation and teamwork across all departments through open, candid communication and timely coordination.
- Create standard work procedures to ensure high-quality and robust manufacturing processes.
Skills and Qualifications:
- Medical Device Validation (IQ/OQ/PQ)
- Statistical Process Control (SPC)
- Statistical Analysis: Design of Experiments (DOEs), ANOVA, Gage R&R, T-Test, Tolerance Analysis Interval, Control Charts, and Process Capability
- Proficiency in Statistical Software (e.g., MiniTab)
- CAD Design (e.g., SolidWorks)
- Technical Writing
- Public Speaking
Preferred:
- Experience with Manufacturing Simulation Software (e.g., Flexsim)
Education:
- B.S. in Engineering or Biomedical Engineering OR
- M.S. in Engineering or Biomedical Engineering
Experience:
- Minimum of 1+ year of professional experience in a Medical Device Manufacturing Environment.