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Manufacturing Engineer Contractor

BioPharma Consulting JAD Group
Houston, Texas, US
Full-time

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.

Interested in this role You can find all the relevant information in the description below.

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.

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4 days ago
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