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Manufacturing Engineer Contractor

Houston, TX, USA

413 Days ago

Job Description


Summary:
As a Manufacturing Engineer Contractor, you'll be at the forefront of ensuring top-notch quality and efficiency for automated and semi-automated production processes. This role focuses on the validation (IQ/OQ/PQ) of production equipment and processes, with a commitment to patient safety and product quality.

Key Responsibilities:

  • Lead & Execute validation activities (IQ/OQ/PQ) for both automated and semi-automated equipment, ensuring new or revised production systems meet rigorous standards.
  • Innovate & Implement manufacturing processes for ophthalmic medical devices used in essential eye surgeries.
  • Optimize Production by applying Lean and Six Sigma techniques to streamline processes and improve quality.
  • Ensure Process Stability through Continuous Monitoring and Statistical Process Control (SPC), keeping equipment validated and processes in control.
  • Analyze Quality with ongoing statistical evaluations of Critical Quality Attributes (CpK/Process Capability) to ensure product specifications are consistently met.
  • Hands-On Support for production equipment, providing expert guidance from installation to post-release.
  • Design & Develop fixtures using CAD software (e.g., SolidWorks) to enhance production operations.
  • Collaborate Cross-Functionally with all departments, fostering a team-oriented environment through open communication.
  • Establish Standards by creating comprehensive work procedures to maintain robust and reliable manufacturing processes.

Skills & Qualifications:

  • Experience with Medical Device Validation (IQ/OQ/PQ)
  • Strong understanding of Statistical Process Control (SPC)
  • Proficiency in Statistical Analysis (Design of Experiments, ANOVA, Gage R&R, Control Charts, Process Capability)
  • Skilled in CAD Design (SolidWorks) and Technical Writing
  • Public speaking abilities to communicate findings and recommendations
  • Familiarity with Manufacturing Simulation Software (e.g., FlexSim)
    • Requirements

      Education:

      • M.S. in Engineering or Biomedical Engineering or
      • B.S. in Engineering or Biomedical Engineering

      Experience:

      • Minimum of 1+ year of professional experience in a Medical Device Manufacturing Environment.

      Qualification

      Bachelor's Degree

    Key Skills Required

    ManufacturingCADAnalysisBiomedical EngineeringCAD SoftwareCommitmentCommunicationComprehensiveContinuous MonitoringDesignGuidanceInstallationMedical DeviceMedical Device ManufacturingPatient SafetyProcess CapabilityProcess ControlProduct QualityProduction OperationsPublic SpeakingSimulation SoftwareSix SigmaSolidWorksStatistical AnalysisStatistical Process ControlTechnical WritingValidationWriting

    Job Overview


    Job Function: Other

    Job Type: Contract

    Workplace Type: Not Specified

    Experience Level: Mid-Senior level

    Salary: Competitive & Based on Experience

    Experience: 0 - 0 yrs

    Contact Information


    Company about us:

    BioPharma Consulting JAD Group is a full-service technical support and solutions provider for companies in the FDA-regulated industry. We understand the importance of bridging the gap between business strategy and results, and we are here to help our clients succeed. Our mission is to partner with our clients to provide...

    Company Name: BioPharma Consulting JAD Group

    Recruiting People: HR Department

    Website: http://bpc-jadgroup.com/

    Location

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