In my opinion, I believe the results above are not surprising. After talking with few people in the industry and seeing it myself through internships for 2 years, it’s clear that employees need to be challenged and that the employers should have a career path set up. If there is an opportunity for the employees, where they are respected and h…[Read more]

In my opinion, I believe the results above are not surprising. After talking with few people in the industry and seeing it myself through internships for 2 years, it’s clear that employees need to be challenged and that the employers should have a career path set up. If there is an opportunity for the employees, where they are respected and h…[Read more]

This is a really interesting topic to discuss. What motivates me is something challenging and realizing that the work I do everyday improves human life. I like it when my brain is busy doing something for a good cause or figuring out ideas when working with a project from planning to completion. For example, in my capstone project, I was…[Read more]

During my capstone project, we had several mini projects to accomplish in order to complete our final project. For example, our project was to create a device which measures three parameters, blood glucose, activity, and oxygen rate and transfers this data to a UI via web server. One of the team members worked on designing the back end software…[Read more]

During one of the project in my internship, I had to perform Gage R&R studies on few parts in order to validate the measuring equipment. I planned out a strategy and started working on testing out few parts. After about 75% into the testing phase, I realized that there was wrong tolerance set up in the machine for measurements. In this kind of…[Read more]

This is a really interesting topic to discuss as this type of situation often happens in a workforce. During my co-op experience, I was a part of the huge transfer project in which my company acquired another small medical device company. In this project, many departments collaborated as it was huge acquisition and needed a team effort. One of…[Read more]

During my work experience, if we need to file for 510k or FDA approval, we use the flowchart developed by the company and the FDA to guide us during the entire process. The process is so broad that there are multiple steps and different classification of device before submitting an application for an approval. At many times, if it’s a family o…[Read more]

During my work experience, if we need to file for 510k or FDA approval, we use the flowchart developed by the company and the FDA to guide us during the entire process. The process is so broad that there are multiple steps and different classification of device before submitting an application for an approval. At many times, if it’s a family o…[Read more]

In my past experience with project, it is very hard to see the complete process as they are very detailed. I have seen a project follow the normal process of, Initialing, planning, Executing, and Closing. However, I was mostly involved in the Executing phase of the project. Upper management and Directors might have a broad vision of the entire…[Read more]

I agree with most of the participants regarding product recall due to a device failure. Product recall is the worst thing that can happen to a medical device company. It can affect the business assets, the people involved and the end client. In this particular situation, change control procedures should have been followed by the company. It is…[Read more]

Engineering change order (ECO) is an official change notice that one initiate upon seeing something wrong in the process or if there is a documentation discrepancies in the engineering drawing. After the initiator fills in the necessary action, it then is routed for an approval from the higher management. Basically, the higher management just…[Read more]

In my senior design project (capstone), we were supposed to come up with an estimated project cost and track as we progress with buying parts for the project. Just like in any project, our budget varied throughout as completion of the project. Our main component called, “E-health board” was the costliest component of about $ 200. The other sma…[Read more]

During one of my co-op experience, I worked with the design and instrument validation of many measuring devices. As a result, I was involved keeping critical notes on file because validation of a device is not something that can be finished easily without running multiple variations of the tests. Many times, I had to refer to my own notes to see…[Read more]

I agree with most of the participants above regarding the issues that may arise while the project manager is out on a leave. These issues are very common in the industry and the project team must get adhere to. As a result, there needs to be better communication with the project stakeholders. Also, there needs to be sign off paper, which…[Read more]

I agree with all the participants in the posts above regarding the role of PM and his or her duties of Quality Assurance. Quality Assurance responsibility is a huge task within Quality in a medical device industry. Few tasks that I will be responsible in terms of input are to make sure to obtain complete details of the manufacturing process…[Read more]

One challenge that the project manager face on a daily basis is the ability to properly communicate the deadlines of multiple projects. There are many active projects going on in a company. Many times, the project manager doesn’t have the time to attend different project meetings. As a result, he or she will miss out on the critical i…[Read more]

During project planning, cost estimation and time estimation for completing a project is the most challenging task for the project manager. There are many of factors that can affect the project manager in making these decisions. Sometimes, it’s the end client who requests a change at the last minute and the supplier must incorporate to make t…[Read more]

I agree with all of the participants in this post regarding Dr. Simon’s class. This is my first semester as Masters in Biomedical Engineering and also first time taking a class with Dr. Simon. In my bachelors at NJIT, I was briefly exposed to FDA regulations in medical devices and most of it I learned through my professional work experience. T…[Read more]

This is a really interesting topic to discuss. I understand your point that missing a milestone in a project means company loses money, bad reputation etc. However, this is not always the case. I believe it really depends on the situation or project. For example, during a capstone project, we had missed several milestones, which resulted in…[Read more]

I agree with all the participants that the project timeline and the scope depend on the type of the project. For example, if it’s the same project the company has already done in the past, then it will require minimal research. However, if it’s a new project, then there will be time spent in training and then SME will assist the project man…[Read more]