I agree with the previous posts on how a new vendor should be found. I definitely think that the vendor should be notified first to make sure that they are aware of the large influx of defective materials. If that…   Read more»

Slack time is extremely important to account for project members being sick, going on vacation, weekends, holidays, or possible delays. It extremely important especially when having complex projects related to medical devices as well as other fields of the medical…   Read more»

While listening to Dr.Simon’s lectures, he mentions that you have to take into account the work schedule of your employees, holidays, vacation time, and if your project members are working on multiple projects. When you don’t take these things into…   Read more»

 In my opinion, missing a milestone can either be detrimental or just a minor setback but it just depends on what milestone is missed. I would say if the milestone was some initial testing to see if there is any…   Read more»

I think when a new project manager takes over there is a sort of tension between the employees and the project manager. Since they are new to the team, it is a little difficult to form relations with the employees…   Read more»

During the pandemic, I was one of the employees at my company that had to continue working at the office. Yet sometimes this would cause issues because other parts of the company could work from home and it was difficult…   Read more»

Risks are normally considered to have a negative connotation due to the fact that it is always referred to as the possible hazards there are within a project or an action. Most companies will assess a lot of the risks…   Read more»

I tend to think that there are no natural leaders but develop those abilities based on those around them and the experiences they face. In my opinion, they are nurtured to have these traits and are able to grow their…   Read more»

When dealing with failures during testing,  I believe that reviewing what went wrong, altering the testing procedure and keeping a level head is extremely important. Keeping a level head is extremely important in the field especially when failures happen because…   Read more»

In my opinion, I tend to favor that each person has their own individual section than creating groups to divide up the work. In a group there always tends to be people that tend to carry more of the workload…   Read more»

If I was able to ever be apart of the design control process, I would want to be apart of design verification. To me, design verification seems really interesting since its testing the design of the product. I think testing…   Read more»

Even with the FDA regulations and procedures, I think there is always room for improvement but they do try to update the guidelines as more information comes out. Yet I think most of the responsibility should fall on the device…   Read more»

As the previous posts have stated, the verification testing should have specifications that should be met with listed tolerances. Even how the product is made should be specified, such as machinery used, speeds, materials, and even the shape. The procedure…   Read more»

Since I am more interested in research and testing, I would choose the product development phase. I feel like I would enjoy this part of the regulatory department because I would like to be more involved in how the product…   Read more»

I know that the FDA has to do in-depth research to justify that use of toxic substances in small amounts but at the same time, I read many articles and saw that it wasn’t antifreeze but just a component that…   Read more»

In my opinion, I don’t think that it is harder to get other group members to agree on final product decisions if there is open communication and everyone has a similar understanding. Even if group members come from different backgrounds,…   Read more»

Although I think interpersonal skills are extremely important within the engineering field, I feel like technical skills are just as important. In my opinion, 70% interpersonal skill has more of a meaning in saying that you need to use this…   Read more»

While I do agree that you need to set reasonable deadlines to make sure that individuals can meet them without rushing or overworking themselves, sometimes that isn’t very possible. Within my field of regenerative medicine, I have seen where engineers…   Read more»

In my opinion, being a project manager means to not only have an in-depth knowledge of the project but also having an understanding of the employees that you are in charge of and working with. Sometimes there can be conflicts…   Read more»