Complete requirements for this position are as follows Masters degree in Mechanical, Industrial or related engineering field and one 1 year of experience in reliability engineering in the medical device industry. Experience must include one 1 year of experience in each of the following Risk Mgmt. Deliverables to include Use, Design and Process FMEA, and Product Hazard Analysis; Variable and Attribute Test Method Development and Validation; Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering; Complaint and Product Failure Investigations, pre and post market root cause analysis, CAPA, and Non Conforming Material Requests; FDA 21 CFR 820, ISO 13485, ISO 9001, and ISO 14971; and DOE, ANOVA, Confidence and Tolerance Limits, Gage RR, Capability analysis, and Six Sigma Methodology.
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