V&V Engineer

Responsibilities - Carry out validation activities (e.g., SE comparison/clinical investigation, usability testing) and perform statistical data collation & analysis. - Define and execute the project verification test strategy, covering electrical, environment, biocompatibility, algorithm and EMC function etc.. - Prepare and routinely update TD doc to ensure compliance. - Coordinate with certified third-party laboratories to verify requirements, and work with regulatory agencies to obtain required certifications. Requirements - BS/MS degree in Biostatistics, Public Health, Biomedical Engineering or related field; - Proficiency with statistical software such as SAS, Stata, or R; - Experience with standard product development full-lifecycle processes; - A team player with clear communication and a conscientious, detail-oriented working style, with a willingness to learn and grow; - Knowledge and experience in the following areas is a plus: verification and validation of Class III active medical devices, and/or orthopedic equipment used in hospitals; - At least 2 years of relevant experience.

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