After working for a company for several years, many engineers are eventually faced with making a decision about their careers: Do they want to pursue a Managerial or Technical track. Often times, a ma...

I don't think there is one "essential" design control. Design control is an essential process that guidelines how to create a safe and effective medical device, so each step in the process is essentia...

Personally, I enjoy working in a larger project team. As you've said, "people can have different backgrounds and areas of expertise" and I think that really adds value when working in a project-settin...

As we've learned, the regulatory role is crucial in the development of medical devices in order to meet all requirements set forth by the FDA. That being said, how important is project management for ...

I think the most important management skill to grasp is understanding conflict. There are 2 types of conflict: Relationship-based and Task-based. Relationship-based conflict is when a person is disagr...

Posted by: @ajy6 Product development and post-market management are the two major functions of the regulatory department. Out of the two, which one would you want to work for and why? Also, which one...

Some major advantages of grouping projects under a program include sharing/leveraging resources, personnel, and project capital, as others have mentioned. Another major advantage that I have noticed f...

One particular skill that helps me keep projects on track is strict time management. Not only is it important to have the timeline set and agreed upon early in the project initiation & planning ph...

I agree with @cassiem , I think that the projects that interest me the most are difficult and complex projects. Difficult projects allow you to push outside your comfort zone and achieve things you ma...

I, personally, have never worked with consultants in the Medical Device industry. However, I do think consultants can be a very useful tool. One area I think that consultants can be of use, in particu...

Hi Dr. Simon, At the start of the semester, in one of your very first lectures you said that this course will get you a job. At the time, I didn't think that could be true. As the class continued and ...

I recently received a job offer and while reviewing my offer I noticed I would have to sign a non-compete agreement, which is an industry standard. I asked the recruiter if I would be able to read the...

Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project ac...

Posted by: @cef3 So there may be more than just the 3 main organization types that Dr. Simon presented in the lecture: Say you were to start up a medical device company that will function worldwide....

Personally, I have only worked in a Matrix-based organization and really enjoy this organization structure. Out of the three options, I think the Matrix-based would be my preference because of the sha...