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

Requirements

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.