I think that all the companies should go forward with the initial planning of the the project. Once the project is proposed, there is a chance the company might getting funding. It not, it was always a good risk to…   Read more»

The past summer, I did an internship with Prosidyan. They are a medical device company which create and produce bone graft substitutes. The company’s customers were mainly doctors/surgeons at hospitals. We would send the material to the hospitals around the…   Read more»

The classification should not and will not change when the material is changed. Of course a PMA will be needed will filling out the paperwork but even if it is a new material, the class will not differ. This is…   Read more»

Project proposal should be done with extensive research of the device you are proposing along with how it will help the consumer. It should include the market gap between the competitors and how money it will bring to the company….   Read more»

Regardless of the project’s type, size and scope, it is important to create a high-performance quality plan template that includes all the tasks and activities required for setting up quality targets, assuring expected performance levels, controlling changes occurring in the…   Read more»

I have had design control experience in the industry as well as in academics. In the industry, I have had only the chance to read through all the design controls. But when I took Dr. Simon’s class last semester, I…   Read more»

I have had a pleasure interning with two companies in the past two years. My project managers for both companies have had a management style of giving me enough freedom to finish the work they have given me in however…   Read more»

These skills are important because if you are not able to communicate with others, how is it possible to get work done? At a job, you need to keep everyone posted about what you are doing and if you need…   Read more»

It’s not in the engineering world where you need to know how to convey your ideas, I believe it is something that every single person should know how to do. If you don’t know how to talk to others or…   Read more»

I think that the big companies should keep the low priorities projects. When they do that there will be more benefits from it since all of the projects are completed no matter how small or low priority they are. The…   Read more»

I would choose matrix for a medical device company because it is flexible to pick members for the project without having to fully remove them from throt positions. The employees must report everyday to the manager and this allows for…   Read more»

It would be ideal to work in a team where the members are knowledgeable in their department role and I have a good relationship with. When you have this combo, it is a setup for success. When you have someone…   Read more»

I think I would be best suited for the middle management because I can be a manager and delegate on the project work but I will also still be responsible for some technical work to get done for the project….   Read more»

For both the companies I interned at, had me sign non compete agreements. I had to agree that I would not work at a competing company for at least a year I was done interning with this company. This was…   Read more»

For me personally, written agreements are better because it is set in stone and nothing can be forgotten. If a verbal agreement is made, some of the things maybe forgotten by one or all members of the agreement. Projects can…   Read more»

The restrictions that the gifts have to be less than $100 and have to be educational is a bit restricted I believe. I agree with the fact that the gifts should be educational but putting a number on how much…   Read more»

Regulations are very important to any company because the products have to follow a certain standard for safety. Some people may argue that it is unfair but the FDA does a really good job to ensure the standards are followed…   Read more»

I never had the chance to sit down in a risk management meeting but as working as quality intern, I did have a chance to read an FMEA. They are very very long and there are numerous revisions. Each new…   Read more»

To change the way we think about risk, we must avoid making six mistakes. 1. We think we can manage risk by predicting extreme events. 2. We are convinced that studying the past will help us manage risk. 3. We…   Read more»

When the design controls are not proper, it may cause the project to be set back because the product can not be cleared unless everything is correct. Design controls are in place to have the product design properly so that…   Read more»