I worked as a QA co-op and experienced the conflict between QA and another department. The conflict I experienced was the QA department with the manufacturing department.QA is very by the book and ensure that all the procedures as well as the instructions are being followed. There was a lot of conflict on how we should fix part issues. The…[Read more]

I worked as a QA co-op and recently finished in the summer. My day to day task varied depending on if any issues came up with machines or parts. On an average day, I would work on document updates and quality standard reference (QSR) updates. I would also work on my assigned CAPA which usually takes up most of the day for a good amount of time. I…[Read more]

I worked as a quality intern and participated in a BSI audit over the summer. The first thing we went through were gaps in our current documents and work instructions. If we found any gaps we would issue a CAPA to show the auditors we are working on a solution to the problem. We than do a walk through to each station. We make sure there are no…[Read more]

I recently read an article that was published in 2015, that discussed if the FDA was being to strict and the consequences from it. The article argues that the FDA is strict because there are more severe consequences from approving a bad drug than failing to approve a good drug. It’s difficult to take a side here because if the FDA was not strict a…[Read more]

I recently just finished my internship in August and had the opportunity to work with many people from different backgrounds. In terms of their physical looks, it has never impacted my work. Each person had their own drives and ideas in any project we worked on. And this made it very productive because we were able to come up with a lot of ideas…[Read more]

I do not think e-cigs should be classified as a class III medical device due to the lack of studies regarding it’s safety. Also, class III devices are classified as devices that have a high risk to the user. I think classifying e-sigs as class III would be too much. In 2016, FDA apparently required that e-cigs would go through the FDA approval…[Read more]

Research in academia versus industry differ in many ways. The first is that industry research is usually aligned with what is high in demand in the market or it must be aligned with the goals of the company. It usually focuses on producing what is needed as soon as possible in comparison to academia research which is less stringent and may be more…[Read more]

I personally am interested in research that would be beneficial in the present. I agree that most researchers probably do not go into this with a set timeline such as if it is for the present or future. I do think that some research is more doable now than others which may need more advance technology.

I understand that research done for future…[Read more]

I understand where groups such as PETA believe testing animals for research is unethical since there are some cases where the animal may suffer. I do believe though it is more unethical to do research testing on humans first. As zha7 mentioned above, right now we do not have an alternative. In the near future, an alternative method may be using…[Read more]

I worked under two different project managers in the past year. The first project manager I worked for was very assertive and wanted the work done earlier than the deadline. She would constantly check my work and give me feedback. The other project manager I worked for was more laid back and the complete opposite of the first one. He did not check…[Read more]

One of the projects I worked on was to create an on-site document to manage our special processes, casting, hot isostatic pressing and solution annealing. This involved closely working with a statistics expert in Warsaw. One of the biggest obstacles that prevented us from closing it on time was proper communication. Our meetings were disorganized…[Read more]

The best work dynamic for a medical device project is a team whose members trust each other and have an ownership mentality. Each member should contribute to the project. It is important to have someone lead the project which a lot of times is the manager. To avoid issues such as the Space Challenger incident in 1986, every member on the team must…[Read more]

I have had the opportunity to work in the industry as well as academia. I worked as a research assistant under a PhD student for a year. A lot of times, working in academia can mean repetitive work. This is true especially in research. I spent the past year doing the same thing every day in the lab. Research takes a lot of patience in order to…[Read more]

I am a non-traditional BME Student. One major advice I can offer is said above in almost every comment which is to get a co-op/internship. Real word experience is very different from what we learn in our classes in school. I would say you should also get involved in research early on in your college career. This will allow you to decide if you…[Read more]

In my experience so far in the BME field, there are more cons than pros. One of the cons is what you mentioned above, BME is too broad. In the company I worked for, a lot of the engineers studied Mechanical Engineering. Most of them said they decided to obtain a more specific degree while taking BME courses on the side. This allowed them to be…[Read more]

I currently work in the industry, so a lot of the things mentioned here were familiar. This class has allowed me to understand the processes and procedures in medical device better. This class also helped me understand what goes on behind planning projects and the importance of it. I do not have much experience in planning but because of this…[Read more]

I learned the importance of a team. I learned that a successful project starts with a team that is willing to communicate and work together to achieve a common goal. I also learnt how important your social skills are in this industry. Even if your experienced and know what your doing, you will be noticed more if you have the social skills as well.…[Read more]

I am motivated by challenges and learning constantly. I love being given several task and deadlines and meeting them on time. I take every opportunity I can to learn. So I try to finish the project assigned to me as early as possible so I can start working on new projects. I have to constantly be using my brain and I don’t enjoy slow days. My…[Read more]

I believe American’s overworking is a mix between motivation and just having too much work to do. Right now because I am young and new to the field, I enjoy being given tons of task and responsibilities. I end up working late because I am motivated to finish my projects so I can be assigned new ones. I would say I am very motivated to learn as…[Read more]

I would say at the moment, I would want to work as an engineer. I have been in the field for less than a year and I noticed manager’s do more paperwork while the engineers are more hands on. I want to gain as much experience as possible and be exposed to several situations. Eventually I would like to move into a management role since I enjoy being…[Read more]