Requirements for a project proposal are as follows: A description of the product along with its intended use and targeted customers. The market size and selling price should be included. There should ...

The quality plan or quality manual of a company shows the commitments of the company to quality and compliance. Upper management has executive responsibility. Some companies adopt clauses written with...

In my current position, my team and I focus on Design Verification that is within Design Controls. Design Controls is an extremely important guide to engineers within the Medical Device industry. I be...

Since the FDA sees the Fitbit as a nonregulated device then it will stay as such. If the FDA considered the Fitbit as a medical device then regulations would need to be in place. Given that the device...

Regulated industries are regulated with reason. Yes, it may hinder innovation however it is to ensure that the devices created are safe and effective for the general public. The regulations placed in ...

Verification and Validation should be done in accordance with Design Controls to ensure proper alignment with correct processes. Verification should be completed after outputs of a design have been es...

As as934 stated, it depends on the business. Upper management decides what the company should focus on given prior experience, etc. Low-priority projects are often put on the back burner because of th...

There are other engineering programs that better prepare the student for the given coursework, however, students should also take the initiative to work on their interpersonal skills. Given the nature...

I believe that this isn't restricted since bribery isn't and shouldn't be taken lightly. As stated in lecture, doctors would receive expensive packages and deals from company employees just so that th...

Before discussing whether if an NDA acts as a substitute for a patent, it is worth mentioning the differences between the two. A patent is essentially a given right to the inventor saying that he/she ...

For one of the company's projects, myself and other colleagues had to sign an NDA regarding the project circumstances and to not disclose information or penalties will be enacted. Before signing, we h...

I would form a project team based on the recommendations from my manager. I would utilize my manager's experience within the company to create a team that in theory can best perform to execute actions...

The organizational type that is most effective (best) depends on the team members associated with the project. Coming from a matrix organization, I believe that having a strong foundation from managem...

I work as a Quality Engineer in a company that runs as a matrix organization. The management provides excellent guidance to their team on various aspects. Also, the directors amongst the different dep...

As a Quality Engineer, we have AQL levels in place in our drawings for the Quality Inspectors to use when inspecting incoming product that is to be used on the manufacturing floor. As neb2 stated, AQL...