The preference between engineer and manager is certainly a personal opinion. The engineering field does often call for the manager to have more technical background. Manager positions are found in pretty much every industry. However, an engineering manager is expected…   Read more»

It is absolutely possible for a project to have multiple priorities. Priorities should always be tasks that might affect the timeline of the project. Sometimes multiples things may be affecting the timeline. It is important to focus on each of…   Read more»

I think many people choose the medical device industry, as it often entails exciting and challenging work. Being able to work with products that improve people’s quality of life is an extremely motivating factor. I found this week’s lecture interesting,…   Read more»

It is important to identify the problems first. There needs to be a clear definition of the problem to determine how it will be dealt with. Is it a design problem, process problem, or resource problem? Whatever the problem may…   Read more»

The most common method to fill project team spots is to pull from other internal teams within the company. Most companies will have teams dedicated to certain functions. These resources can be pulled into the project to support.  Sometimes there…   Read more»

I don’t believe this week’s simulation was an example of un-ethically rushing a product to market. The license agreement was a business agreement between the vendor and the client. The agreement gives a royalty to the vendor every time the…   Read more»

The scaling of the size of teams is crucial to project performance. In simple terms, you need to have enough people to complete the tasks. As you mentioned, some bigger companies may have dedicated teams assigned to a certain task…   Read more»

Hi All,   Unlike most in this course, I am actually a ME Master’s student at NJIT. As part of my curriculum, I am allowed to take 3 courses from any discipline. I chose this course because I work for…   Read more»

I would define a successful project as one that has all its tasks completed. In the medical device industry, this can often be releasing a product to market. The project itself is always set up to complete a certain goal….   Read more»

Gantt charts are fantastic for laying out the project timeline. The best tool I’ve seen for creating Gantt charts is Microsoft Project. There are also several free versions, but Microsoft’s version has many great features and Office integration. The issue…   Read more»

You should not set out to design a verification test that cannot fail. The engineer should strive to design a test that can accurately verify that the specifications of the product are met. This heavily depends on what type of…   Read more»

Working from home definitely has some advantages and some drawbacks. The benefits of this workflow will vary on a case-to-case basis. It obviously depends on what kind of position it is and what industry. For certain positions, working from home…   Read more»

Accounting for the duration of tasks is sometimes more difficult than it sounds. The only real way to know the duration of a task is to just measure it. This can be captured in various types of process studies. Knowledge…   Read more»

Sometimes the success of the new project manager can heavily rely on how diligent the previous project manager was. It will take the new PM some time to learn about the project, and gain an idea of the current status….   Read more»

An important factor in the medical device supply chain is quality. Like any other industry, medical device companies want to optimize costs and increase profits. What makes them different is that their suppliers have to maintain a high level of…   Read more»

I believe the development phase is the most important. By this time most of the groundwork for the project is complete. The planning and design phases are complete, and major project deliverables are beginning. The project team begins to finalize…   Read more»

As many others have suggested, it is a good start to look at similar products. Even if a true predicate device does not exist, risk strategies can be adopted from other products. The risk analysis process should also be standardized…   Read more»

There would have to be something fundamentally wrong with the project in order to go back to a previous phase. The design review process is set up to guide the project forward. Certain requirements must be met to move on…   Read more»

I do not believe that additional approval would be required for a medical device that has already had a PMA. However, all medical device manufacturers are subject to audit from the FDA. Audits can be conducted at certain intervals depending…   Read more»

It is important to understand how you would define underperforming. Is the team member failing to meet deadlines? Are they continuously making mistakes? Are they showing up late often? As a team leader or manager, it is necessary to clearly…   Read more»