I've seen PFMEA used by process engineers for machines. PFMEA us used to identify the different failure modes for the machine and ways to fix this issue. For instance, some of these issues could inclu...

A type of risk management seen in manufacturing is a concept called "Poka-yoke." It's a Japanese term that translates to "mistake-proofing" and was developed by Japanese engineers at Toyota to avoid e...

The validation process ensures that all the customer needs are met so that a successful, good quality, and reliable product is made. Thus, it requires rigorous, well-planned, and well-thought-out test...

Initiating document releases and revisions are a crucial part of an effective quality management of any device. In fact, there is a cycle that every document goes through which includes its creation, ...

Design Matrix with columns for inputs, specifications, validation, and verification is a good starting point but each device has to adapt to its own design process system and all the requirements incl...

This is usually written out within the companies mission/vision statement. They really care about the quality of their products, especially in the medical field, so they will take every effort to do e...

Some of the design verification plans that is done for companies that manufacture medical devices are to see if that devices meet their design specifications and intended purpose. So this will be test...

That is true. We did follow the design control process for capstone where we first wrote up the customer requirements, design requirements, test plans, and evaluation of the test plans. These are basi...

Compensating participants is a necessary part of any trial but there are ethical concerns that arise under coercion and exploitation. In third-world countries, people who come from a poorer background...

Another main concern that nobody has brought up yet is informed consent. The individuals in the trial should make their own decision about whether they want to participate or continue participating or...

Placebo pills work because the person taking its expects that pill to work and it works(sometimes) because of the power of the mind. For instance, stress has been shown to increase blood pressure whic...

I am wondering, does people think that it is worth working as a sales/marketing engineer role in a company. I feel like there isn't much engineers, in the first place, that would be more interested in...

To be in any position that requires marketing as an engineer, you have to be able to help service both the customer and the business. I feel like this job is for people that possess the ability to ini...

If you really want to go into management type position(such as project manager or technical specialists), I would definity do an MBA since you have to be very business focused for this type of job. Th...

Something that I have learned working as an intern is an MSA, or more specifically a Gage R&R study, in which a measurement system, in which our case was a tool used for pull force testing our pro...