I can see how this could be a common problem in industry, especially when Project Managers get requests from stakeholders not directly involved in pla...
There are many reasons why a certain product or process will require changes during its life cycle. One example could be cost. To attain certain tight...
There are plenty sources of input to pool from when developing the Design Input Document (DID). Other than the marketing department you should be coll...
I do not think this is a problem as there have probably been hundreds of medical devices approved using predicate devices and which have probably bene...
I currently work as a manufacturing engineering co-op for a medical device company which is most like a functional organization. Each department has t...
I think there are different situations with the labeling which could result in either immediate corrective action or even a recall. As we have have he...
While this could make it easier to globalize healthcare and allow for easier import/export of drugs and devices, I think it will make it harder to bri...
I do think that interpersonal skills are a tremendous asset in the workplace, I do not think that people can just fake their way through without a goo...
To me, this is probably one of the hardest part of the design process. There are many problems associated with creating tolerances for various aspects...
I do think these restrictions are a bit too harsh. Sure expensive steak and wine dinners are not the most useful allocation of resources but I also do...
Dr. Simon, As someone who has been working at a medical device company for almost a year, I found this extremely relevant and helpful. It sort of rei...
This is an interesting dilemma you brought up. I think you should divulge as much information as possible under the protection of the Non-Disclosure A...
I think as a project manager you would want a matrix structure. Project-based structure lacks efficiency in that there can be members of the team who ...
While these two are similar, I think education really separates these two levels of management. Being an engineer I am more inclined towards being inv...
I currently work as a manufacturing engineering co-op for a medical device company which is most like a functional organization. Each department has t...