I have worked as a risk management intern for a medical device company and have spoken with a lot of team members who have worked in risk management for years. I would say that their day-to-day tasks are highly dependent…   Read more»

I worked as a quality assurance engineering intern in a medical device company this past summer. One of my projects involved the review of tests conducted to prove a particular device’s compliance to the European Union Medical Device Regulations (EU…   Read more»

I worked as a risk management intern (Quality Assurance) in a medical device company and I can say with confidence that one of the most important things to consider while maintaining a quality management system in this field is preventative…   Read more»

I agree with the previous commentor: MSA is critical to making sure that you are providing exactly what you said you would. Without MSA, there would be no consistent or reproducible data to show that your device should be on…   Read more»

I agree with most of the commentors here saying that a company needs to be 100% transparent with the FDA. It’s for the safety and efficacy of the device coming to the market and it is 100% necessary to avoid…   Read more»

Although not entirely ideal, I believe the FDA handled the vaccine rollout in the best way they could. A big component of getting people vaccinated was fighting against misinformation, which is always an uphill battle. Misinformation can spread easily and…   Read more»

The development of a medical device is a project, so it would benefit from project management-related tools such as Gantt charts and WBSs. Especially in an industrial setting, planning in advance with these tools are absolutely essential in making sure…   Read more»

Some interesting biocompatibility tests I found are sensitization assays, irritation tests, and subchronic toxicity testing. Sensitization assays are tests done to show any adverse effects a certain material can have if exposed to a tissue for a long time. Most…   Read more»

Academia research would absolutely more enjoyable for the sake of research. Being on the threshold of human knowledge and being able to take and sit on as many projects as you like is very appealing. Being able to discover and…   Read more»

It’s difficult to determine the relative importance of the steps of the project lifecycle because they are all necessary to complete a project. It’s similar to looking at a perfectly functional four-legged chair and asking yourself “Which leg is the…   Read more»

I think to a certain degree, project managers need to be comfortable with interacting with people. If someone has severe communication issues or social anxiety, they might not thrive in project management specifically (although they might be fantastic in other…   Read more»

When examining the differences between industry and academia, the one thing that jumps out the most is the end goal of each.In academia, you’re working to advance the field. The goal is ambiguous. You’re performing research to prove or disprove…   Read more»

The importance of one’s GPA soley relies on where you are in your career. At the start of one’s career, they are likely going to need a relatively high GPA coupled with some relevant experience. Most companies throw out resumes…   Read more»

I think there are two major steps to achieve personal growth and development in the workplace: having specific goals and always being willing to learn.In order to achieve personal growth and development, you have to understand and figure out what…   Read more»

Having fixed hours versus working to complete one’s work both have pros and cons and is likely going to depend on not only each person’s preference, but their manager’s management style as well.Having fixed hours is attractive because it sets…   Read more»