Dr Simon, I enjoyed this course pretty thoroughly. It is refreshingly different from most courses at NJIT in the sense that it gives information about how the world actually works, not how a concept w...

An NDA is a way of allowing you to tell some things, but not the whole story. It is analogous to if you told someone a family recipe for cookies. "A little flour, sugar, vanilla extract, a special ble...

Verbal contracts are hard to defend in court and are thus not quite as actionable. Generally, if it is important and there are risks associated with one party backing out, it goes in a written contrac...

In upper management you have real control over the company but most of your work is confined to maintaining the company and dealing with finances legislature. You are in the position of maintaining th...

From my experience the best impact of worker performance is leadership. This works both ways, poor leadership means very poor outcomes. A leader needs to firstly have a clearly defined vision. Without...

The first thing our team did was go over the timeline of the project. We set up a simple flowchart of what has to happen and what everyone needs to do. Then, we started giving tasks to the people that...

In the assessment of risks of devices section (4.2) the standard lists duration of the risk as a parameter. This is an important distinguisher because it dictates how much damage a risk can do under w...

The type of risk plays a role in what statistical analysis you need when testing. Most companies here just use a higher sample size when testing high risk hazards but I believe it can go deeper than t...

I believe the best results from a risk analysis meeting come from minimizing bias. The beginning of the meeting is about finding hazards by going through the chronological life cycle of the project. S...

I am president of a new start up club on campus and we have used various methods to keep track of the meeting progress. Having someone take notes throughout the meeting and upload them directly afterw...

The Gantt chart is a useful organizational tool, if not for actually keeping track of the project timeline. When creating the Gantt chart, you are forced to think about reasonable time estimates for t...

If you were to make a device in the EU, it would be subject not to the regulatory documents required in the US but to those required in the EU. Every country has its regulating body that ensures the s...

We learned about many different project design documents that are needed to produce a product in industry. I am curious to know what the equivalent of these documents is if working in academia. For re...

Statistical sampling tests I have used for research included the paired t-test and one way ANOVA. Typically, for something to be taken as statistically significant, a power of 95% or better is needed....

Verification ensures that the the customer specifications are meant. Without verifying specifications, you are blindly trusting what the manufacturing department took to be what was meant on the DID. ...