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.


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