One of the most famous Six Sigma tools called DMAIC (Define, Measure, Analyze, Improve and Control) offers a structured approach for resolving organizational management-related issues. DMAIC can be un...

Gantt charts are a valuable tool to have in project planning arsenal. Managers use them to perform a variety of project management (PM) functions, including: -Visualize the critical path. -Set baselin...

The design review meetings were held with the head of the departments and each of the changes were reviewed and if anyone had any input to what else should be added or if any other changes should be m...

At Prosidyan, the engineers redline the latest version of a document online using track changes. Before redlining, the engineer will create a DCO(document change order) with new revision and why chang...

Risk–benefit analysis is analysis that seeks to quantify the risk and benefits and hence their ratio. Analyzing a risk can be heavily dependent on the human factor. A certain level of risk in our live...

I do not agree with this statement of the book. I do not think medical device companies "lack transparency and proper clinical trials". None of the medical devices will be in the market if they were n...

I think that all the companies should go forward with the initial planning of the the project. Once the project is proposed, there is a chance the company might getting funding. It not, it was always ...

The past summer, I did an internship with Prosidyan. They are a medical device company which create and produce bone graft substitutes. The company’s customers were mainly doctors/surgeons at hospita...

The classification should not and will not change when the material is changed. Of course a PMA will be needed will filling out the paperwork but even if it is a new material, the class will not diff...

Project proposal should be done with extensive research of the device you are proposing along with how it will help the consumer. It should include the market gap between the competitors and how money...

Regardless of the project’s type, size and scope, it is important to create a high-performance quality plan template that includes all the tasks and activities required for setting up quality targets...

I have had design control experience in the industry as well as in academics. In the industry, I have had only the chance to read through all the design controls. But when I took Dr. Simon's class la...

I have had a pleasure interning with two companies in the past two years. My project managers for both companies have had a management style of giving me enough freedom to finish the work they have gi...

These skills are important because if you are not able to communicate with others, how is it possible to get work done? At a job, you need to keep everyone posted about what you are doing and if you n...

It's not in the engineering world where you need to know how to convey your ideas, I believe it is something that every single person should know how to do. If you don't know how to talk to others or ...