MEDTRONIC, INC. – $113,714.00/Year

Requires a Bachelors degree or foreign equivalent in Biomedical Engineering, Mechanical Engineering, or Biomedical Science, or a related technical field, and 4 years experience with quality engineering for medical devices; Or Masters degree or foreign equivalent in Biomedical Engineering, Mechanical Engineering, or Biomedical Science, or a related technical field and 2 years experience with quality engineering for medical devices.br br Must possess at least 2 years experience with each of the followingbr br Risk Mgmt. Deliverables to include Use, Design and Process Failure Mode Effects Analysis, and Product Hazard Analysisbr GDT and Variable and Attribute Test Method Development and Validationbr Product Performance Specifications, Design Verification, Design Validation and Design Transfer, Usability and Human Factor Engineering, Component Risk Assessment, Component Qualification, and Supplier Change Controlbr Complaint and Product Failure Investigations, pre and post market root cause analysis, Complaint and Product Failure Regulations and MDRVigilance reporting requirements, CAPA, and NCMRbr FDA CFR 21 part 820, ISO 13485, ISO 9001, and ISO 14971br Lean Six Sigma, Cause and Effect analysis, Design of Experiment, ANOVA, Confidence and Tolerance Limits, Gage RR, and Capability analysisbr br Multiple positions available.