Medical Device Courses | sseal98 | Activity

sseal98 replied to the topic "Understanding Project Management as a Non-Project Manager" -

Mon, 02 May 2022 04:58:46 -0400

Being able to know project management is I believe an essential need for all engineers and project managers alike. Being able to know how decisions are made and how much time is needed for a deadline and what goes on… Read more»

sseal98 replied to the topic "Regulations in cases such as pandemics" -

Mon, 02 May 2022 04:30:45 -0400

Being working in the pharmaceutical sector and working on the development of the COVID Vaccine, I could tell that the initiating and planning phase that we experienced was not all that different from what would be done otherwise. All practices… Read more»

sseal98 replied to the topic "What’s Your Motivator?" -

Mon, 02 May 2022 04:25:05 -0400

My biggest motivation comes from watching those around me work hard which motivates me to work hard. Every time I sit down to work I thrive in an environment that fosters great work culture and a place where everyone is… Read more»

sseal98 replied to the topic "Let's Be Motivated!!!" -

Sun, 24 Apr 2022 19:20:36 -0400

I really like this thread and keeping everyone positive and I agree with everyone saying that the project manager’s motivation level is paramount to keeping the team on task and keeping everyone motivated. Some key ways that I would implement… Read more»

sseal98 replied to the topic "Engineer vs. Manager" -

Sun, 24 Apr 2022 19:10:47 -0400

I would probably want to work in the industry and work as an engineer and on the front lines to gain as much experience and then after I have sufficient experience, then I would like to move into project management…. Read more»

sseal98 replied to the topic "Quick, Fast, Good? Pick Two" -

Sun, 24 Apr 2022 18:56:59 -0400

I believe that in a biomedical application, the most important factor that is necessary is to make sure that the product lifecycle is good and cheap. The quality of being fast is a plus, however in my opinion for a… Read more»

sseal98 posted a new topic "Familiarity of eachothers work" -

Mon, 18 Apr 2022 04:01:27 -0400

From a project management standpoint, when you have multiple parts to a team, say one group taking care of one aspect of a project and another working on another project, do you think it is important to take precious time… Read more»

sseal98 replied to the topic "Changining staff" -

Mon, 18 Apr 2022 03:58:00 -0400

If a person were to leave the team leaving a critical job behind in a critical stage, it would be important to have a contingency plan from the start. If it were to be me in the position of managing… Read more»

sseal98 replied to the topic "Time Management" -

Mon, 18 Apr 2022 03:50:26 -0400

I have had a situation where the timeline of my project had to be pushed back. When managing my first project and having to look at deadlines and timelines, it was up to me to figure out how everyone’s timeline… Read more»

sseal98 replied to the topic "Negative Schedule Variance" -

Mon, 28 Mar 2022 03:18:35 -0400

When it comes to schedule variance being negative, it is important for the project manager to discuss with the rest of their team what is the best course of action to bring the schedule variance into the positives. However, some… Read more»

sseal98 replied to the topic "Weighing Input of the Timeline" -

Mon, 28 Mar 2022 02:58:27 -0400

I believe the most realistic timeline would always come from those who are working with each other to get the project finished, however, in reality, they usually have the smallest input or depending on the project manager, has some say…. Read more»

sseal98 replied to the topic "Making connections between people and schools" -

Mon, 28 Mar 2022 02:31:45 -0400

Hi Everyone, My name is Sourav Seal, I am currently a M.S student at NJIT studying Biomedical Engineering. I’m also working full time as a Senior Associate Scientiest at Pfizer! Please feel free to follow me on my LinkedIn page!… Read more»

sseal98 replied to the topic "What you need to get a job in project management" -

Mon, 14 Mar 2022 03:34:04 -0400

I would have to agree with @srp98 in that for a project manager to be successful, one has to be an engineer themselves to gain insight into the projects the team might do. Also, it is important to have a… Read more»

sseal98 replied to the topic "The power of the board of directors" -

Mon, 14 Mar 2022 03:22:07 -0400

A board of directors has a lot of say when it comes to projects that might help or hinder the group depending on how big the project is. The purpose of the board is to determine if the direction of… Read more»

sseal98 replied to the topic "How poor planning affects a project" -

Mon, 14 Mar 2022 03:00:40 -0400

When in the initiation stages and planning I have experienced with my team that it is quite often that people who are quite higher standing and upper management oftentimes set unrealistic goals without consulting the team initially. This happens often,… Read more»

sseal98 replied to the topic "Figuring out tasks." -

Sun, 06 Mar 2022 21:37:03 -0500

In terms of project management, splitting up each processes into teams and having them focus on their own specific tasks would allow for more focused tasks and having each team have bite sized products to work on. This ensures that… Read more»

sseal98 replied to the topic "Unique Project Challenges for Medical Device Companies" -

Sun, 06 Mar 2022 21:28:51 -0500

Medical device companies indeed have a certain level of hoops to cross when it comes to project managing. For starters the most important aspect as said by the question mmd55 is the regulatory ramification and hope that the product dosent… Read more»

sseal98 replied to the topic "Career Path to becoming a project manager" -

Sun, 06 Mar 2022 20:52:53 -0500

I believe that it is important and beneficial for someone who wants to go into project management to first work as a project engineer or work in the fields so to say. This is because there are certain skill set… Read more»

sseal98 replied to the topic "Project Manager Changes" -

Mon, 28 Feb 2022 03:33:11 -0500

When a project manager is changed mid-project, the one major drawback is the team chemistry and the preferred way of managing by the team. Every Project Manager has their own way of communicating with the team and leading them which… Read more»

sseal98 replied to the topic "Penalization for Going Over Budget and Time?" -

Mon, 28 Feb 2022 02:44:00 -0500

I do not believe that if a team is going over budget or is not able to complete their task because of a delay, they should not be punished because oftentimes there are variables that are out of the team’s… Read more»

sseal98 replied to the topic "Project Slack Time" -

Mon, 28 Feb 2022 02:12:30 -0500

Having some slack time is just as integral as having a solid start date and finish date, this is because slack time accounts for many variables that are out of a project manager’s hand such as inclement weather absence, machine… Read more»

sseal98 replied to the topic "Changes in Risk Management for Pharmaceutical Companies" -

Sun, 20 Feb 2022 21:02:46 -0500

I believe that vaccine production for companies can become a very profitable business as well as doing good for the world. When we look at it, the polio vaccine was able to eradicate Polio from the world and it only… Read more»

sseal98 replied to the topic "Communications Management Plan" -

Sun, 20 Feb 2022 20:45:20 -0500

I have not had to deal with such a type of document, however, I could see the importance of such a document. When a large project has many moving parts and communication channels, a document that lays out how to… Read more»

sseal98 replied to the topic "Changing thee project" -

Sun, 20 Feb 2022 20:35:33 -0500

This is an excellent question that deals with many issues and dynamics of a project proposal and verification protocol. I believe the sole purpose of the verification protocol is to be able to catch said mistakes and anything that was… Read more»

sseal98 replied to the topic "Should Interpersonal skills be more valuable than technical skills?" -

Sun, 13 Feb 2022 00:30:52 -0500

This topic has been an age-old topic on what is more important, technical skills or interpersonal skills. In my opinion it is highly important to be able to communicate what your wants are and to clearly express yourself when in… Read more»

sseal98 replied to the topic "Design Review Meeting" -

Sat, 12 Feb 2022 23:39:36 -0500

The only solution that I can think of making sure a design review goes as swiftly as possible is to make an agenda that everyone is distributed to and to actually stick to the schedule. However anyways to fast-track the… Read more»

sseal98 replied to the topic "Difficult People in Work Groups" -

Sat, 12 Feb 2022 23:25:11 -0500

The above answers from both @srp98 and @leshan bring up good points that clear communication skills is important for any team as it establishes the group dynamic and how the group will workin the future. On top of establishing a… Read more»

sseal98 replied to the topic "Leaders: Nature or Nurture?" -

Sun, 06 Feb 2022 21:48:25 -0500

I too believe that there are elements of both nature and nurture when it comes to taking lead and responsibility and a certain level of confidence that is required for a project manager or a leader. To be in a… Read more»

sseal98 liked forum post "Leaders: Nature or Nurture?" -

Sun, 06 Feb 2022 21:43:37 -0500

sseal98 replied to the topic "Career Decisions: Managerial Vs. Technical Tracks" -

Sun, 06 Feb 2022 21:41:23 -0500

In my 1.5 year experiences in where I work, I have both worked in the lab environment and have seen what happens when a person is solely in the project management department and also in the lab. I have worked… Read more»

sseal98 replied to the topic "How to ensure the project is on schedule to meet deadline" -

Sun, 06 Feb 2022 21:18:02 -0500

The above responses have pointed out the importance of managing time to the best of a teams ability and allowing for sufficient time for each and every project. I too work in a lab and i have quickly come to… Read more»

sseal98 replied to the topic "Power and Regulation" -

Sun, 30 Jan 2022 22:10:30 -0500

The FDA in-itself has the ability to keep check and tabs for quality of a product that is going into market that is consumed by people. With that being said, the FDA making mandates on individual diet and consumptions of… Read more»

sseal98 replied to the topic "Class 2 device and 510(k)" -

Sun, 30 Jan 2022 21:25:38 -0500

As listed by both answers, the reason why a 510k would be used is that the main function of the medical device and all its secondary functional parts of the item would have to be the same, and very minor… Read more»

sseal98 replied to the topic "FDA ethics" -

Sun, 30 Jan 2022 21:13:24 -0500

The debate between if one product that is considered hazardous vs a certain amount of it is okay to consume has been a long standing debate between scientist and policy makers. However for this issue, I believe that with proper… Read more»

sseal98 replied to the topic "How would you handle team conflict as a Project manager?" -

Mon, 24 Jan 2022 03:59:20 -0500

I would have to agree with @srp98 in that as a project manager, I believe it is important to understand where two opposing parties are coming from and to know that even though conflict can impede progress, by ignoring the… Read more»

sseal98 replied to the topic "What kind of projects interest you the most?" -

Mon, 24 Jan 2022 03:50:56 -0500

I agree with the previous replies that were left. I prefer projects that are novel and require new and innovative ways to figure out the solution. I prefer a project where the answer isn’t known and it requires trial and… Read more»

sseal98 replied to the topic "How do you deal with challenges?" -

Mon, 24 Jan 2022 03:39:13 -0500

I was working with my team at my workplace to get one of our projects out and it was on a tight deadline. However, in order to do this project, there came a series of roadblocks and standoffs that happened… Read more»

sseal98 replied to the topic "Design Review Meetings" -

Sun, 05 Dec 2021 23:48:24 -0500

I had the opportunity to attend a design review meeting between multiple departments in our specific department. One thing that I noticed that was striking is the structure of the meeting. There was a specific agenda with specific timeline that… Read more»

sseal98 replied to the topic "Validation vs Verification" -

Sun, 05 Dec 2021 23:34:45 -0500

In my industry, I have experience doing method validation and verification on our machines as part of our job. The main difference between validation and verification is that when you are validating something, you are checking if the customer/ the… Read more»

sseal98 replied to the topic "Minutes for meetings" -

Sun, 05 Dec 2021 23:21:15 -0500

Like said by others, I too have been on the receiving side of taking meeting minutes and being part of a meeting where meeting minutes were recorded. As for the importance of taking notes during a minute there have been… Read more»

sseal98 replied to the topic "What are the limitations and protections of trade secrets?" -

Sun, 05 Dec 2021 22:37:58 -0500

While trade secret is an excellent way of keeping a part of your business secret and allowing you to make money on it, it also gives you absolutely no protection from others inventing the same thing that you have made…. Read more»

sseal98 replied to the topic "Non-compete agreements" -

Sun, 05 Dec 2021 21:11:39 -0500

I believe in my experience in the pharma industry, a non-compete agreement is a specific document that prevents an individual employee from taking the companies intellectual property that they have learned from or gained in their profession and time in… Read more»

sseal98 replied to the topic "Controversy regarding Advamed Guidlines" -

Sun, 05 Dec 2021 20:58:34 -0500

In my experience in the pharmaceutical industry, I personally never had to deal with the possibility of paying for a modest meal or doing favors for doctors when talking business but as for company policy I had to do training… Read more»

sseal98 replied to the topic "For those that work in a matrix based organization:" -

Mon, 22 Nov 2021 21:24:49 -0500

I work in the pharmaceutical industry where I have one main responsibility/project that I have to do and in the afternoon, i have my other projects which are considered my side projects. In this matrix method, I often find my… Read more»

sseal98 replied to the topic "Traits of upper management versus middle management" -

Mon, 22 Nov 2021 21:16:20 -0500

Upper Management is often responsible for leading the whole company as a unit and is often not focused on the daily occurring of each day. They are responsible for developing a large grand direction towards what the company will be… Read more»

sseal98 replied to the topic "Different Organizations for Different Industries" -

Mon, 22 Nov 2021 04:51:28 -0500

Personally, I work in the pharmaceuticals and I believe we see a lot more of the matrix solution being used combined with a type of functional organization. For me, I directly report to one functional manager who manages my personal… Read more»

sseal98 replied to the topic "Benefits of post-market surveillance" -

Mon, 15 Nov 2021 03:59:58 -0500

Post market surveillance is absolutely a good thing for a company to do after releasing the product. By watching how the product performs a company can come to the conclusion of what the next generation of product needs to include…. Read more»

sseal98 liked forum post "Factors going into Buisness" -

Mon, 15 Nov 2021 03:35:09 -0500

sseal98 replied to the topic "Risk Management" -

Mon, 15 Nov 2021 03:21:34 -0500

Risk management is just as important in my opinion and experiences in industry as the actually Research and Development phase of a project. Being able to look at potential risks associated with the product not only helps with mitigating individual… Read more»

sseal98 replied to the topic "Ways to deal with risks" -

Mon, 15 Nov 2021 02:58:30 -0500

So in my perspective, I have worked in the pharmaceutical industry and many of the same points that are being taught in our class are essentially the same. The two often times coeincide with each other as each of them… Read more»