I don’t believe it is completely necessary to have a clinical background to work in this field. To say you need have a clinical background for a role is highly limiting the talent pool that would potentially be interested in the company or role. Engineers that are solid in solving problems, have an extensive background in math and science, and have worked in medical device or pharmaceutical industry, would be excellent candidates for these roles. The part that is lacking, is the interaction aspect of working with patients. However, I believe this can be learned on the job or through training and possibly seeing if they acquire a certain certification. This doesn’t need 3-5 years of clinical background experience. There are engineers that work for companies that I’ve personally seen who are just as qualified or can be easily qualified to work with patients and administer or coordinate clinical testing and research.