One of my friends had taken this course before and suggested it to me because it really helped with her knowledge of FDA regulations and when interviewers asked her about this. I had previously taken a few courses about FDA regulations but it never went into the same depth that this class goes into so I'm grateful for that. I also very much appreciate the insight I get into a project manager. More likely than not I'll be having a project manager as my boss someday and having this knowledge of project management gives me a level of understanding that will definitely help make both our jobs easier.
This course has echoes many of the things I experience on a daily basis at the company I work for. As a small medical device company, each team member has expanded roles and responsibilities. Although I primarily work in R&D and quality, I am very often involved in regulatory meetings. Having an understanding of FDA regulations has helped me tremendously in these meetings by allowing me to define my role more clearly in assisting projects move forward. Additionally, this course has also helped me do a better job at planning and documenting the things I need for my specific functions. By having a better understanding of verification and validation procedures, I am better able to plan and meet my responsibilities.
I would say this course is a must for anyone and everyone looking for career advancement in any field. It really helped me by giving an insight into the life of a PM and helped me understand better the roles and responsibilities of a PM and how important it is for a Project Manager to plan, manage, execute and deliver the projects thereby satisfying the expectations of the client or customers. As i'm working through this course i'm gaining lot of confidence and dependability on my team members apart from developing strong leadership and interpersonal skills as it provides terrific virtual environment to work on the task or challenges in the same way you would do at the workplace. There are few more things that i have learnt so far i.e. to define the clear objectives for the project and to set the goals in a realistic manner so as to deliver the task before the deadline. By the end of this semester, i will go for the certification in the Project Management which Professor Simon mentioned about on the day one as it holds high value in companies. I felt this course was more useful than any theoretical core course i did so far.
I feel that this course is very beneficial to a lot of students who are looking for jobs within industry because through this course, we are exposed to real-world circumstances and work place situations. I’ve learned a lot about what occurs within industry in terms of hierarchy and work flow. This class has also exposed me to a more formal and intuitive thinking when approaching group projects. In this class, I’ve also learned to work with different team and different types of people in accomplishing a project. I’ve learned how to adjust to people’s different learning style and work approaches and I’ve done a lot of adjusting and learning. I’ve learned more in-depth information regarding medical device development such as FDA regulation and other company processes that they take for their product to be released. One day, I hope to become a project manager like my dad. Currently, I am within different project within school and other clubs and I use what I learn in this class to formulate a practical and successful approach.
Its a good opportunity for a Biomedical Engineer to know what he/she must do when goes for a real world. We only get to learn about the stuffs and actual application of it is really a kind of difficult one for us. This course gives awareness about the real world of medical technology and teaches how to handle a project when it comes to you. The simulations are effective ones which make us to come up with the solution, that indirectly give us experience to handle an unfortunate scenario of our future careers. I would say that the course is simple and clearly organised. We never get messed up with lot of details and get confused because of the complexity. Personally I feel this course develops critical thinking in me. I am impressed with the course set up and its effect on us. The group simulation shows us the real team work and its advantages and disadvantages. Each one should take at least one course of Dr. Simon to experience the real work of Biomedical Engineer.
After graduating with a Bachelor of Science in Biomedical Engineering, I did not feel as prepared for interviews as I do now after taking one of Dr. Simon’s courses. About halfway through my undergraduate study, I had the impression that upon graduating I would have a developed understanding of common practices expected for a project engineer position. Unfortunately, I found out that entry level biomedical engineering positions were slow to come by and even just a little bit of project management knowledge can take you a long way. Learning about the process groups, FDA regulations, and the general structure of a project has been very insightful. I feel much more prepared and desirable for project engineering positions after learning about project management techniques and common industry regulations.
Hi Guys,
So I know we all have been posting discussion questions regarding simulations and all the lectures each week. However, I wanted to get your input on what you think so far about this course?
My personal experience, I took medical device development with Dr. Simon two semester ago and currently my last semester at NJIT, I am enrolled in both of Dr. Simon's courses. I have been applying for jobs in the industry and in a couple interviews I gave in the past semester, I found out that most of the information thought in Dr. Simon's courses is very useful during interviews. Many employers do not expect college graduates in the engineering program to have much knowledge on FDA regulations, Marketing Clinical Trials, or Project Management techniques. So in one of my job interviews, the hiring manager asked me if I ever heard the term GMP or GCP. Luckily, since I was taking medical device development at the time, I was able to answer this question with a lot more detail verses someone who took only engineering courses.
What is your opinion regarding this course and what have you learned so far that you did not know previously?
This being my last semester at NJIT, this is the second course I have taken with Dr. Simon. The first course I took was Medical Device Development. From both of these courses I learned things that I did not learn from any other class. Medical Device Development was able to show me how to work in an actual project team. It was also beneficial to see how the different parts of a project team work. In Medical Device Development Dr. Simon assigns a project where students need to create a project team. Each person on the team represents a different department from the company and they have to prepare the files that their department is in charge of. This gives us insight into what a real job will be like and no other class really offered that to me. This class has the simulations which are very important. This teaches us how to deal with real life problems and how to find solutions for them. Dr. Simons classes prepares us for our real life industry jobs. Academia is important but so is real life situations that we will encounter.
This is my first time taking a course by Dr. Simon, but the knowledge is already so valuable to my brief experiences in industry. I work as a global supply chain data management co-op at Johnson & Johnson and a lot of the practices, techniques and information that we go over in this course is highly useful for my actual job. I can actually apply some of the knowledge into my work experience. The simulations and going through them as well as reports are also highly valuable to a student transitioning to the industry. That is what I would say the course has the most to offer. It gives students who are already or actively working in industry more insight and additional knowledge that will help them succeed and flourish in their respective workplaces.
Hi Guys,
So I know we all have been posting discussion questions regarding simulations and all the lectures each week. However, I wanted to get your input on what you think so far about this course?
My personal experience, I took medical device development with Dr. Simon two semester ago and currently my last semester at NJIT, I am enrolled in both of Dr. Simon's courses. I have been applying for jobs in the industry and in a couple interviews I gave in the past semester, I found out that most of the information thought in Dr. Simon's courses is very useful during interviews. Many employers do not expect college graduates in the engineering program to have much knowledge on FDA regulations, Marketing Clinical Trials, or Project Management techniques. So in one of my job interviews, the hiring manager asked me if I ever heard the term GMP or GCP. Luckily, since I was taking medical device development at the time, I was able to answer this question with a lot more detail verses someone who took only engineering courses.
What is your opinion regarding this course and what have you learned so far that you did not know previously?
As someone who has been working in the industry for a few years, I can say first hand that the information we learn in this class is definitely useful. I wish I had learned this information in my undergraduate curriculum, because it would have helped me get ahead and hit the ground running once I started working. Regardless, the things we learn in this course further enhance my knowledge of the product development process, FDA regulations, different types of testing, as well as overall project management skills. This information can absolutely be leveraged when applying for jobs to give you an advantage against other people applying for the same position, since you can showcase your knowledge of industry-related information that would otherwise be learned by spending months on the job.
My thoughts on this course are that it is filled with so much information and it is delivered well. I think the forums as well as the simulations help students to learn about the industry and make us thing more than as engineers. I had previously taken Medical Device Development last year and this course is different from that. It helps you learn more in depth about what the industry is about and the rules and regulations of the industry. Even if it is only for Medical Devices, most of the material that is learned can be applied in other areas as well (of course with other rules and regulations but still applicable). As an online class, everything is presented well. It helps those who are working, to learn at their own pace with ease. Even while working in the industry, I feel like I have learned a lot more about the industry to help me understand what I do at work. This course is much different material that helps people figure out the industry and see if Project Management is for them.
This is my second course with Dr.Simon as I had previously completed Medical device development. This course is more beneficial to students who are looking for jobs after completion of course, to work in the real world. I would say that this course is much useful and clearly well defined. The group simulation helps to gain exposure to work with team members efficiently and productively. This course helps to give awareness of FDA regulations and helps in, how to handle a medical device project when it comes to you. Overall this course is more practical than theoretical as it gives the students, the exact scenario of how the companies are operating in the real world.
As someone who is currently working in the medical device industry, I find the information discussed in this course to be very relevant to my day-to-day job. Even if you are an engineer, like myself, and not a project manager, it's still very valuable to have knowledge of project management since your career will most likely involve working on lots of projects, and oftentimes engineers will move into a project management role as they advance in their career. Also the discussion forums are a great way to think about the big picture of how the topics we learn about in the lectures can be applied to the real world. For instance, before reading a forum topic in this class about the new European MDR, I was not aware of it, however now that I know what this new regulation is and that it's coming into effect this year I noticed that my company is revising many of our SOPs to include information and definitions relevant to the MDR. Even if you do not have industry experience yet though, this course will help you get an idea of what to actually expect in your job, and will definitely be useful for job interviews.
I have found that both this class and Dr. Simon’s other class to be very insightful and useful. The knowledge gained from this class has helped me several times through my classes. I am currently completing a masters thesis revolving around the creation of a medical device. I am planning on completing a PhD to continue to study and complete the device and eventually I would like to go to market with the device. This knowledge that I have gained in these two classes has made it much easier for me to understand what I need to do both during development in terms of documentation, as well as what will be needed in the future, so I can design in a way that will make it easier for me further down the line. These two classes will be invaluable when it comes time to get a job at the end of my PhD as I want to go into R&D for diagnostic devices, and having an understanding of the whole process will make me a more valuable hire.
the course gave me the opportunity to learn more about the medical devices field in the US, as I have finished my bachelor degree from foreign country and lived almost all of my life there, I had zero knowledge on how things here. After this course, I will be more confident applying for new jobs and be an effective team member where i can apply the knowledge i have learned.
This course has opened up a whole new criteria for me regarding FDA and product development. Although I have worked for industry, I have not been opened to the other responsibilities of an entire team and what it takes to get a project started. I think that the exposure to FDA regulations and having a high level understanding of it will be a key asset to have while applying for other jobs. Rather than having a technical skill, having a background in regulations is a breath of fresh air to an engineer.
