I’ve had to sign a non-compete agreement 3 times so far. First was when I worked for a consulting firm – I was not allowed to work directly for their clients or recommend their employees for hire to my new…   Read more»

Fortunately, I have not yet been laid off and gone through this. However, I have gotten a release letter from when I wanted to leave my consulting firm. They tried to take advantage of the fact that if I quit…   Read more»

Consultants are generally hired when a company does not have the specific resources for a task/project or the company does not have enough resources to complete task/project on time. In my previous job we hired the an engineer who had…   Read more»

Every company I’ve worked for has so far been a matrix organization. While I have not had experience functional or project-based organizations, I feel confident in saying that I would prefer matrix organizations. Even in matrix organizations I’ve noticed politics…   Read more»

Posted by: @sts27 In all honesty, I think that the traits of upper and middle management are quite similar (depending on how you look at them). Both are required to be able to communicate effectively, articulate plans and goals, monitor…   Read more»

Posted by: @traceymraw Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or…   Read more»

ISO 14971 is the ISO regulation governing Risk Management and its major requirements for medical devices are: Identify risks Estimate the potential occurrence of risk and evaluate extent of consequences Put in safeguards to control risks Regularly review and monitor…   Read more»

I’ve participated in a couple of audits. US FDA, Korean FDA, Internal, and MDSAP. My participation was always limited to specifically my documents so I was questioned on some things but was able to adequately clarify everything. Some of the…   Read more»

I’ve done and am actually in the middle of a shelf life validation for raw materials and final device. We’ve included in it packaging, transportation, and storage studies in accelerated and real-time aging. In the past, I’ve done software validations…   Read more»

They are related in a sense that both are used medically but they both have different levels of risk. Medical devices, whether it be implants or blood typing machines, aren’t chemical compounds made to react a certain way in the…   Read more»

From what I have observed during my working experience in Medical Device companies as Production Engineer, Quality seems to operate under two main strands: Quality (Ops) and Quality (Compliance). As Production Engineer- I have gained experience with working both sides….   Read more»

@bjv9 Yeah, absolutely, some countries have have regulations that are more strict than the US and for that reason some drugs or devices banned in other countries are actually deemed safe in the US. For example: Sudafed is available in…   Read more»

My previous employer sells blood typing kits to many countries around the world and we are regulated by several bodies around the world. While most of their focus overlaps other things like labeling requirements have small differences which could mean…   Read more»

Posted by: @orleron Up until now we have talked about two big topics:  project management and pre-clinical research.  There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk…   Read more»

I think it would be appropriate to say this topic is like a double edge sword. Just as with any controversy or disagreement, I think dialogue is the best way to go about it. Both side need to discuss the…   Read more»

The most important things is will. What is achievable, understandable, and affordable? While these are absolute in their importance and relevance, they’re all ultimately subjective. Your idea could be achievable, understandable, affordable, and solving a very important problem but the…   Read more»

I think hands down MP (Microsoft Project) is the most comprehensive and most popular PM (Project Management) software out there. It’s a part of the Office Suite of software from Microsoft that easily integrates with other Office software. For example,…   Read more»