Prior to clinical trials biocompatibility testing should be completed in regards to ISO 10993. The types of biocompatible tests needed for a particular device can be determined by using the toxicity table. General biocompatible tests include cytotoxicity, genotoxicity, irritation and implantation. By completing these tests you can determine how…[Read more]

Project manager for a medical device company differs from that of a building/skyscraper due to FDA regulations. Project managers of medical device company have to follow design controls and regulations which abide to FDA guidelines. A project manager of a building or medical device both have to follow the phases of a project life cycle but will…[Read more]

Coming from an individual who has work experience in academia and industry there are pros and cons for both career paths. In terms of moving your career forward based on your work, industry is more promising. When you work in industry all of you work helps to promote you up to a higher position while in academia you have fewer opportunities to…[Read more]

The current academic to practical course ratio provided by NJIT is not beneficial to students entering the workforce. From personal experience, I found it shocking that my bachelor’s degree did not really prepare me for the medical industry. Only 3 courses out of my undergraduate degree were relatable to my workload as a working engineer. Last s…[Read more]

I do not have a six sigma belt certificate but I have heard about it from employees and friends. A friend of mine was able to get a job as a Lean Manufacturing Engineer because they received a six sigma green belt. With the knowledge gained from taking a six sigma course my friend is able to decrease the time and increase production output on the…[Read more]

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 month thinking that he would be getting fired for standing up. I asked him one day why he never became manager and he told me “If you want to high…[Read more]

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 feedback on how to improve. However, when I talk to the engineers who have stayed at the company for longer periods of time they are completely…[Read more]

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 work then you remain stagnant which will cause people to dislike going to work. The second driving force for me to work at a company would be the…[Read more]

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 their workload. But when the project manager is in his office everyone is focused and working extremely hard. A major project deadline was April 10th and…[Read more]

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 have my own ambitions, confidence and passion to drive myself to go beyond my limits. Of course, my family is a big driving force to keep me on the…[Read more]

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 I wanted to keep the scope simple. However, after hearing my classmates projects and how complex they were I got worried that my project was way too…[Read more]

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. What quality levels are you seeking?
3.What stock levels do you require?
4. How often do you require delivery?
5.What price points are you…[Read more]

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 breaks down each process for each major product line. Within each process their are set protocols or procedures along with controls. Each process for…[Read more]

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 and project processes. The managers should have held design review meetings after each design control phase. Within the design review meetings the…[Read more]

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 class two medical device. But to verify that it should follow CDRH guidelines an RFD (request for designation) must be completed. If it is assigned…[Read more]

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 class two medical device. But to verify that it should follow CDRH guidelines an RFD (request for designation) must be completed. If it is assigned…[Read more]