MEDTRONIC, INC. – $103,189.00/Year

The Senior Quality Engineer position requires a Masters degree in Industrial, Mechanical or Manufacturing Engineering and two 2 years of experience in manufacturing or industrial engineering. The position requires a minimum of 2 years of experience with each of the following the design and manufacture of Class II and Class III medical devices; navigating engineering principles within an FDA regulated environment and following ISO13485, ISO14971 and ISO 9001; process validation IQOQPQ, DOE and Gage RR; design for DRM Design, Reliability, and Manufacturing practices and tools using Solid works modeling software; Lean manufacturing and Six Sigma methodologies, incorporating GMP Good Manufacturing Practices, 8D Problem Solving and DMAIC Problem Solving; CAPA Corrective and Preventive Action planning and implementation; and Risk Deliverables to include Use, Design and Process Failure Mode Effects Analysis FMEA and Product Hazard Analysis.