Tuesday, October 26, 2010

Senior Quality Engineer (EE) St Jude Medical - Plano, TX

Apply Online

The Senior Electrical Quality Engineer assures that electrical devices and firmware meets all regulatory and voluntary standard requirements. This includes participation in the design validation process and review of schematics and designs. Final product verifications and validations may also be included. Risk assessment is a key component of this position.

Major, On-Going Responsibilities:
• Review design output specifications based on product requirements
• Participate in design and development peer and project reviews
• Develop test plans with the Development and Marketing groups
• Review requirements, specifications, schematics, flowcharts, and designs and recommend improvements
• Review workarounds and fixes to product issues in the defect management system
• Ensure that development process follows internal procedures and external standards/guidelines for design control
• Write and execute design validation protocols
• Perform risk management activities to ensure products and processes are safe and effective

Experience & Training:
• Bachelor's Degree in Electrical Engineering or engineering-related discipline pertinent to the medical device industry.
• 7-10 years electrical or firmware quality assurance background is required
• Experience with medical device or regulated industry is required
• Experience with formal development methodologies and electrical design is recommended
• Experience with risk management and ISO 14971 familiarity is a definite plus

Click on the link below to apply via the St Jude Medical Career site ~ scroll 1/2 way down the page to see the Sr. QE position:

Apply Online

No comments: