I have seen this first hand at work in the past month. One Senior Engineer spoke up against upper management about an issue in a major product line. That senior engineer was walking around the whole m...

A lot of people do tend to leave their job because they became stagnant or the work environment became to comfortable. As a new employee the managers and engineers always praise my work and give me fe...

The results as to why people work seem to be reasonably accurate to my reasoning for staying at a job. Number one motivation to work is the challenge and excitement. If you do not feel challenged at ...

I have seen first hand how the project managers motivation affects the team productivity and motivation. Whenever the project manager leaves for vacation the entire office becomes very relaxed on thei...

A lot of people may say that they are motivated to do work because of their family or wanting to help their community. I on the other hand have always been driven to push my own boundaries. I always ...

During my Finite Element analysis course I worked on a project which had a scope of collecting data to show effects of osteoarthritis. I had a timeline of around two weeks to complete this project, so...

According to an article I read called, "The vendor selection process, How to select a vendor formally?", there are a set of questions you must answer as a buyer: 1. What products do you require? 2. Wh...

Currently, I have been working on updating a pFMEA for Maquet products and they follow a similar 1 to 5 scale to numerically quantify a risk. A pFMEA is a process failure mode effects analysis which b...

Risk Management is necessary when dealing with medical devices. Many companies have different ways of evaluating risk within a project such as using a pFMEA, FMEA or FMECA. There are four main ways to...

In this scenario the type of change control which should have occurred is the ECO (engineering change order). This is when you make changes to the project after it has completed the design controls a...

Surgical Mesh with Antibiotic coating is a combination product which can follow either CDRH or CDER regulatory guidelines. Based on my understanding the primary mode of action would to treat it as a c...

If you have ever participated in a design review meeting please share your experience on how it was in comparison to how you expected it to be. What would you change on the way the design review meeti...

There are numerous monitoring and controlling techniques which were mentioned in this week’s lecture. Which technique do you believe is the most essential in this phase of the design control and expla...

Companies have different procedures in order to submit a design change request. Share your experience on the steps needed to complete a design change request at your company. At Maquet, the engineers ...

Recently, I encountered my first experience not meeting a deadline in industry due to underestimating the time needed to complete the task. The task was to obsolete a product line which should have ta...