Verification protocols are the steps one needs to take to ensure proper guidelines, tolerance values and consistency is met. The protocol will list certain actions that need to be performed as well as the expected or acceptable outcome. In comparison,…   Read more»

I believe what you are describing is “slack”. The difference between the earliest finish and latest finish can be calculated by measuring your skills, workload and external project variables honestly. If a task will take 1 day to complete, but…   Read more»

Both are equally as important, however if one option had to be chosen I believe the manager is more important. A good manager can effectively utilize company resources in order to complete project on time and correctly. An investor is…   Read more»

Slack is important for any project because miscalculations and errors are bound to happen. Of course no one should rely on slack time, however there will always be the chance that a task takes longer than expected especially if multiple…   Read more»

I do not think stakeholders should be involved in the project process. As mentioned their role should be limited to financial oversight and they should leave the project to those they have entrusted their funding to. Of course if the…   Read more»

As previously mentioned there isn’t exactly one answer to this problem. One of the factors that I would consider is the importance of the project. Is this project a precursor to  another project or a series of projects? Is this…   Read more»

I would prefer working in an environment where I have a more roles in a design process. Disregarding any change in workload I think it is beneficial not only for my career but project design skills to better understand the…   Read more»

I feel working in a smaller team better suits more project types. Often time with large teams everyone’s vision for the goal of the project becomes blurred as there are many opportunities to get lost in translation. Additionally, large teams…   Read more»

I believe the most common approach is to divide the project into equal parts for everyone. The discussion would begin with a team meeting where a plan can be made that would detail the direction of the project. This ensures…   Read more»

Working with difficult team members is always a challenge but I find taking a step back always helps. When difficult teammates are head strong about their idea I won’t make the discussion an argument, rather state my point of view…   Read more»

I would prefer to work in a smaller team. I often find that in larger teams work can become unevenly placed resulting in some people working longer or shorter on their assigned areas. Additionally, when information is flowing through fewer…   Read more»

I do not have first hand experience as a PM but I am inclined to think you will understand risk management during your tenor. As a PM you will need to understand steps of the projects you’re working on which…   Read more»

I am inclined to think that the leader personality is a result of nurturing. Sure, from a young age some people are more inclined to lead a group project or become a team captain however that is still a product…   Read more»

If a new function is added to a device then it will most likely require a PMA. If the device remains largely the same but with a slight change you can proceed with a 510(k). For example, to my understanding…   Read more»

I believe the FDA’s stance on this is ethical. If their studies have found that X level of antifreeze is safe to consume and there are no discernable effects from consuming products that have it, I would have no objections….   Read more»

I believe the FDA should not have the power to create mandates. The FDA’s role is to identify hazards whether in medical devices, medicine or food, not to write laws. Similar to the EPA, they are tasked with ensuring our…   Read more»

Challenges during my projects usually revolve around timing and meeting deadlines. The work assigned is usually always doable and within a reasonable expectation to accomplish but often times when handling multiple projects and assignments at one time it can be…   Read more»

I believe all management skills boil down to two main camps: people skills and timing. Management is usually absent from technical roles because they’ll be more directly involved in overseeing multiple projects. This requires excellent people skills in order to…   Read more»

When presented with a conflict I would first hear both proposals being pitched or problems at hand. With everyone together I would help facilitate conversation to work to a compromise or understanding towards each other’s opinion. If this becomes a…   Read more»

To my understanding, a non-compete agreement is a document used to “prevent” employees from leaving their current company and working with another competitor, usually equal in size. However, from what I have read they are rarely enforced because it would…   Read more»