Senior Quality Engineer, Electrical
Job Requisition #: NMD2692
Category: Quality Engineering
Location: Dallas - TX - USA
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
We currently have the following position available in our Neuromodulation Division.
The Senior Electrical Quality Engineer assures that electrical devices and firmware developed for use or sale at SJM NMD 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