Risk Management Engineer
Chester, England, United Kingdom
Sinclair
for individual residual risks and the overall residual risk for specific devices in development and for legacy devices • Maintain a close link to the Human Factors/Usability Engineering process to meet the needs and ensure the safety of all users and patients. • Support creation of device design … that the risk management process incorporates all relevant data from the • Design Authorities e.g., Design FMEAs, Security Risk Analysis, Use-related risk analysis, formative human factors evaluations and human factors validation studies. • Ensure that risk management reports are prepared in a timely manner and in accordance … Minimum of 5 years of experience in regulated medical device industry • Experience in performing risk management for medical devices • Knowledge of usability engineering or human factors engineering for medical devices • Knowledge in usage of risk assessment methods • Specific knowledge of active medical devices If this sounds like you more »
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