Tuesday, October 26, 2010

Quality Engineer - Mechanical (St Jude Medical) Plano, TX

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As a key member of the Quality Engineering team, the QE, ME acts as a quality representative on cross-functional project teams to:
  • assess risks/hazards associated with product designs, processes and applications
  • create quality – related documentation for project design history files
  • develop and execute product tests and validations
  • analyze resulting data, and document results, and 
  • develop and implement processes and procedures.

    Primary Ongoing Responsibilities:
    •    Represent Quality Engineering on cross – functional project teams
    •    Create quality – related documentation for project design history files (quality plan, essential requirements checklist, etc.)
    •    Lead teams in identification of risk/hazards associated with product designs, processes and applications and assist with FMECA generation.
    •    Develop test plans, write protocols, analyze data, and document results in technical reports (product and system validations, sterilization validations, package integrity testing and biocompatibility testing)
    •    Interface with design engineering and develop first article inspection plans
    •    Ensure compliance with product and industry requirements and champion Quality policies and principles through the company.

    Experience and Training:
    •    Bachelors degree in Biomedical Engineering or related
    •    Minimum one year work – related experience in Quality Engineering or a combination of Quality Engineering and Design/Product Development Engineering in the medical device industry and possess a field related Bachelor’s degree.
    •    Ability to analyze problems, work independently as well as in a team environment, and organize and execute multiple work tasks simultaneously
    •    Ability to read and interpret engineering drawings, product specifications, procedures and standards
    •    Experience with active implantable medical devices and class III devices a plus
    •    Experience/familiarity with the domestic and foreign standards related to medical devices preferred; knowledge of these standards related to active implantable medical devices preferred
    •    Experience executing sterilization validations desired
    •    Knowledge and experience with biocompatibility is preferred
    •    Must be proficient in MS Office (Microsoft Word, Excel, PowerPoint, Outlook)
    •    Excellent written and oral communication skills
    •    Good conflict management skills
    •    Ability to learn quickly and multi task
    •    Self motivated and able to work independently as well as in a team environment.

    Apply Online

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