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 industry experience at Ethicon, where I worked mainly on design…   Read more»

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 where these situations occur. This…   Read more»

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 stagnation within their own…   Read more»

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 registered for lean six sigma yellow belt course, and…   Read more»

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 project has…   Read more»

For a project we were working on it was a smaller part of a whole, which was analyzing viral clearance for a legacy product process. At first we did the initial research and looked through historical information within the company…   Read more»

I have had several instances where I’ve had to deal with vendors and our project team has had to work on choosing the appropriate vendor. The initial steps in dealing with the situation are setting up meetings with different vendors….   Read more»

Similar to Davids’s situation I was in the same class and our final project was a novel prosthetic arm. Our proposal was the development of new types of soft robotic structures, especially materials/methods for the fabrication of such robots, involving…   Read more»

An example of a combination product would be Stryker’s Vitagel Hemostat (http://www.stryker.com/en-us/products/Orthobiologicals/SoftTissue/Vitagel/index.htm). The delivery system for this product is a syringe and the primary mode of providing a therapeutic effect comes from the contents of the syringe which is the…   Read more»

An example that I dealt with on a team at work was on a hemostatic agent that we were releasing. The testing that we conducted with the contract lab suggested that there would be potential risk associated with the endotoxin…   Read more»

Although I do not have personal experience with FDA audits. We are always reminded to adhere to the protocols set forth because they are in place as safeguards for if/when audits do occur. Employees at our company are constantly trained…   Read more»

For a animal trial study I worked on we had a cost variance associated with the study, and did end up going over budget as our cost variance was negative. Our earned value on the project was estimated at about…   Read more»

Logging work is definitely an important aspect of research and development for any company. When I started working for my current company about 2 years ago logged research was essential in helping me understand how the research progressed and the…   Read more»

To extend on tn58’s response, a project manager also faces a similar issue with information, not only for budgets but also for product information. It has been a repeated theme in Dr. Simon’s lectures that a PM, especially for the…   Read more»

The best course of action for all those questions is establishing proper communication with all team members. While acquiring team members it is the project manager’s responsibility to organize a rough schedule of team members planned vacations/absences. If you preemptively…   Read more»

This is my first course with Dr. Simon and since I work in industry I had experience in most of the topics that we are learning. The greatest benefit this course provides for me is the thought process on management….   Read more»

Currently at my company we are working on a project that is international, as we must communicate with Brazil, India, and Austria. The key hurdle with project management is the time difference within the countries and the communication gaps. With…   Read more»

Missing a milestone is usually more than a minor hurdle within industry. For a project missing milestones as indicated in your post would waste company financial resources. However, this is not the extent of the damage, along with financial resources…   Read more»

During a project that I was working on our team missed a milestone for our execution of animal trials. We had gone through the protocols for conducting the trial, however there was an error in the paper work required for…   Read more»

As stated by previous responses R&D would be a factor that extends the Gantt Chart and timeline of the project. However, another important aspect of the balloon system popping immediately may cause upper management to re-evaluate the project entirely. This…   Read more»