Design Control Job Roles
As biomedical engineers, there are many different roles that we have discussed in this class that we can do in the design process—research and development, QA, and QC, regulatory, project managers. I have never worked for a medical device company, but does anyone work in a company now that goes through this process and knows how they divide up the roles? How many different aspects of these design controls do you work on as the type of engineer that you are? Does it depend on the size of the company and the skill set of those working on the project or does it depend on the project itself? I was a quality assurance engineer intern, and the only aspect that I gathered I would work with is the validation/verification stage of the project but would later in life love to work in some of the other design controls.
I have not worked in a biomedical device company in this way specifically, I only have non-medical materials experience in industry. What I have learned is basically that it depends on the company as you have said. Some smaller companies will have a huge amount of overlap between these categories. That is by necessity because there are not enough employees at the company for anyone to have a hyper specific role. As companies get larger, overlap between roles can still absolutely exist, but the occurrence of hyper specific roles can and will also increase. The unsatisfactory answer I can give with regards to design controls in specific roles would be that it depends on how the company structure is set up.
I have worked in a company that produces ultrasound transducers. The company was relatively large, so roles for design control were actually pretty defined. I think of it in terms of change management, since I was on the manufacturing side of things and less on preclinical data collection or new product development. This means that every aspect of the product that the company has determined worth measuring is measured and recorded. Changes to acceptance criteria, the manufacturing process, and/or suppliers must be documented, with the coordination of the change handled by the initiator with a controller. This controller is a defined role in a large company but can be merged in smaller companies, similar to what ag2357 has stated. I haven't seen it change for a specific project or by the user's competency and would not expect it since you would like consistency in a process with regulatory implications.
I do not currently work at a medical device company but I work a cosmetic manufacturing plant that employs roles in QA, QC, and project managers that perform similar duties to the ones that were talked about in this week's lecture. Like the original poster, I have had a role as a quality validation engineer who completed IQ/OQ/PQ validations on various equipment that we use at our plant. I would assume the tools and methodology that I had used in this previous role would also be used in a medical device company.
The Design Controls process requires collaboration from essentially every department in the medical device company to ensure all stages of the product are designed with the best quality possible. But in my experience, DC will be led by the Research & Development engineers, and other departments such as Quality, Marketing, Regulatory, etc. will contribute as needed in specific deliverables. Granted I've only worked at one medical device company, so it may be different for other companies. But in general, R&D is going to play a major role since the purpose of R&D is to lead the innovation of new products, or updates to existing products. For example, the R&D engineers will actually create the product's drawings using their knowledge of engineering principles and CAD software, then Purchasing will step in to find a supplier who can reliably make the custom component. Oftentimes it can be ambiguous which department is responsible for what, so the responsible department or even the specific person should be clearly listed in the project's Gantt chart.