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.

A controls design fabricates control systems for machines and equipment such as robots, conveyors, and the likes. They design how conductors, relays, and other components of devices are arranged and linked. Also, they determine how the cables of robots, robot controllers, and other machines are connected.

I have worked in a medical device company as a quality engineer and although I did not directly work with design controls on new products, I did get a chance to learn about the processes quite a bit. The first thing to note I believe is that the amount of teams depends almost entirely on the company and it's particular environment. For example, I worked for a large company, so I learned that in that particular company, every phase had 5-8 groups collaborating on it all at once. Those groups would switch out depending on what function was necessary for the particular phase of design controls. However, I would imagine it would be quite different for small companies. Larger companies require a larger amount of people because they are juggling with a lot of different products while smaller companies tend to specialize and output only a certain type of product. So for design controls, I would not be surprised if only one team worked on the entirety of design controls, although it would be a massive amount of work and quite a lot of outsourcing. The people working on the project likely specialize in the subject matter and they are probably more intimately familiar with the type of device and could have a better understanding of the design controls as they go through the process. Another benefit to a smaller team could be a lower likelihood of miscommunication. With a big company, I noticed there was quite a lot of miscommunication in meetings about design controls because some groups did not have the same context of other groups since they did not work on a particular phase of design controls. This often led to backtracking which sometimes takes a significant amount of time. But again, it would be an immense amount of work for one team to accomplish, so that would be the ultimate drawback. Overall, I think the style of design controls entirely depends on the company completing it.

Having worked at a medical device company as a QA intern, I worked on ensuring compliancy with CAPA records, some of which that were opened because of design controls issues. I think largely, CAPA reports require a heavy dosage of communication and collaboration to address issues with design controls because the manufacturer needs to convey the issues to the quality engineers that can make the judgement on the severity and if it needs to be elevated into a SOP or management-addressed. That being said, it does take manpower to ensure that type of quality and control, which is why larger companies have more resources to accomplish this. I would assume smaller companies with lesser products could scale accordingly since it requires less individuals in the network to get work done.

Different departments within a medical device company have a hand in working with design controls. A quality assurance department may be focused on developing the inputs and outputs for the device, the regulatory department may be focused on ensuring that these align with different regulatory body regulations, and a research and development department may focus on performing the verification and validation for those design controls. Currently, I work within a pharmaceutical company on combination products, and the department has a team called Design Controls and Risk Management, which develops these requirements through documentation, and another team called Device Verification, which develops tests to ensure that these requirements are being met. I work on characterization, which attempts to explore different ways that the device could potentially pose an issue, so typically I would not work with design controls as much as someone in device verification, but the characterization testing would still likely support some requirements for the device. 

I believe that staff skill levels, project complexity, and company size have the biggest effects on design control roles. More specialized positions may exist in larger organizations, enabling engineers to concentrate on particular facets of design controls. Employees can have a greater variety of duties in smaller businesses. The degree of experience and specialty needed for each component of the design controls may vary depending on the complexity of the medical device and the hazards involved. In addition, team members' backgrounds and experiences are crucial in defining their responsibilities during the design control process.