Sr Software Quality Engr
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B.S. degree in Computer Science, Electrical Engineering, or equivalent field
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Preferred: M.S. degree in Computer Science, Electrical Engineering, or equivalent field
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Minimum Experience: 5 years of experience in regulated industry within the Quality, Testing or R&D Engineering function. (2 years of experience can be substituted for an Advanced degree in a related discipline)
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Proven ability to directly lead and/or co-lead multiple tasks and projects.
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Base understanding of industry expectations in the areas such as voice of customer, software development, requirements analysis, risk management, software testing levels, software reliability, etc.
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Experience with Requirements Management tools, configuration management tools, and defect tracking tools.
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Working knowledge of quality engineering principles within a regulated industry (preferably medical devices).
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Working knowledge of the utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
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Ability to work with distributed and international teams.
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Strong collaboration, negotiating, and conflict resolution skills.
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Fluid verbal and written communication skills.
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Fundamental understanding of mechanical/electrical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the new product to ensure the sustainable manufacturing of medical devices both internal and external.
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ASQ Certified Quality Engineering (CQE)
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Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
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Knowledge of scripting languages and test automation.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.