While it is essential for the entire team to identify risks during development, it falls primarily to the Quality Assurance team to ensure that risks are properly identified and accounted for. For this reason, an introductory job quite a few biomedical engineers enter into upon graduation is the QA department, where employees predict how customers will use and, inevitably, break products. My medical sensors instructor’s first job was essential to find novel ways to break medical devices to check for their risks and tolerances.

Much like many other aspects of medical device development, the project manager is the next most responsible for risk management, followed by the rest of the team associated with a certain product. As Myton mentioned, this is an absolutely essential job and the consequences of failing to do a good job can be severe (including personal consequences for the team involved).