A recent prominent recall that happened was part of Johnson & Johnson's orthopedic subdivision Depuy Synthes. In this situation J&J was found negligent in properly informing consumers that the...

An antibiotic hip stem would be considered a combination product “as defined by 21 CFR 3.2 (e)”. The primary mode of action of this hip stem would be to provide similar functionality and support of a ...

Within industry research the main advantage is the resource and workflow that is in place to deliver finished products. For example, currently my role is that of a Process Engineer and the main task o...

While working in industry I did come across a situation very similar to this, in which our company was conducting animal studies for a product under development. The constraint that we had was we had ...

Personally I am more interested in doing research that can be developed into product in a useful time frame. I do not agree that the hard line is between academic doing long term research and industry...

A milestone failure within the medical device industry can be viewed as a learning opportunity and improvement area no matter what stage of the project planning phase it occurs in. With that being sai...

Personally within industry I have used Microsoft Project for creating project timelines. Microsoft Project's functionality to integrate with different functional teams is crucial for project planning ...

For a medical device project I agree that the manager must provide the balance of executive deadlines and taken into consideration the overall safety of the users. However, the role of the manager sho...

I was recently made aware of this ratio as I was attempting to create a schedule so that I would be able to take all 4 courses that you provide in my curriculum. I would disagree with the 3 to 7 ratio...

The biggest difference that I see for academia and industry is the structured projects present within industry and the unstructured projects you can choose within academia. Within industry for the mos...

Currently I am working at Bristol Myers Squibb on a process characterization team focused on bridging the gap between R&D and manufacturing for commercial medical devices. I also have previous ind...

I don't fully agree with the skepticism on lack of upper management willing to listen. While this is definitely an issue within any industry based off my experience it is in the minority of cases wher...

There can be many reasons to leave work, one of which as you stated would be limited praise/recognition. Many times people also feel that they would be better off in a different division if there is s...

Six Sigma certifications are intended to demonstrate that you have the capability of handling complex projects and the problems that may arise while working on them. Through my company I recently regi...

I was not part of a team that had a team member removed to work on another project completely. In my experience it usually isn't a complete removal but the individual that is chosen to work on another...