Masters or foreign equivalent degree in Biomedical Engineering or in a closely related field of study Will accept a Bachelors degree 5 years of related progressive professional experience in lieu of a Masters degree each alternative requirement with at least 6 months of experience in i developing, implementing, and managing process improvement projects; ii leading and mentoring engineers; iii generating and maintaining Quality System documentation; iv FDAISOEN compliance; v Failure Mode and Effect Analysis FMEA, process capability, Design of Experiments DOE, and Gage Repeatability and Reproducibility Gage RR; vi participating in validation activities Installation Qualification IQ, Operational Qualification OQ, and Performance Qualification PQ; vii performing compliance assessments, risk assessments, traceability matrices, supplier assessments, user requirement specifications, and drafting compliance and test plans; and viii NonConformance Reporting NCR. Employer will accept any suitable combination of education, training, or experience.
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