Masters or foreign equivalent degree in Biomedical Engineering, Computer ScienceEngineering, ElectricalElectronics Engineering, or in a closely related engineering field of study Will accept a Bachelors degree with at least 5 years of progressive professional experience in lieu of a Masters degree each alternative requirement with at least 1 year of professional experience in i participating in medical device product development life cycle phases, including launch and commercialization; ii developing and documenting system level requirements using knowledge of requirements management systems, including DOORS or Veeva Vault, and document management systems, including Windchill PLM; iii conducting tests, including Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ and test method validation; iv participating in nonconformance investigations, troubleshooting, and systemlevel analyses; and v applying knowledge of Design Controls per 21 CFR part 820 and ISO13485, Risk Management per ISO14971. Employer will accept any suitable combination of education, training, or experience.
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