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.