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Manufacturing Engineer Contractor

BioPharma Consulting JAD Group

Houston, texas


Job Details

Full-time


Full Job Description

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.

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