Medical Device Courses | njq3 | Activity

njq3 replied to the topic "Clinical trials when exporting medical devices to other countries." -

Mon, 02 May 2022 00:44:58 -0400

It’s definitely trickier because outside countries have much different regulations than the US or wherever the medical device originates from. There may even have to be a redesign of the project or at least further clinical trials to allow the… Read more»

njq3 replied to the topic "Engineer vs. Manager" -

Mon, 02 May 2022 00:40:41 -0400

It can be said that it is an ultimate goal for most people to end up in a managerial position (perhaps even a director or even higher), while I have held some managerial positions as well as engineering positions, I… Read more»

njq3 replied to the topic "Lessons Learned Documents: When to look back" -

Mon, 02 May 2022 00:36:02 -0400

It’s always important to look back at any lessons learned document because as you said, knowledge transfer is key. I’ve seen too many times where a new hire comes onboard and really lacks a lot of critical knowledge that can… Read more»

njq3 replied to the topic "Quality control in small projects." -

Mon, 18 Apr 2022 00:43:11 -0400

I agree with @anthonynjit above – sometimes budget is not there for smaller projects therefore there is less QA/QC support on that end. A company needs to prioritize at the end of the day. I think in this case where… Read more»

njq3 replied to the topic "Complications with Management Sectors" -

Mon, 18 Apr 2022 00:35:59 -0400

Recently I’ve taken on a role as a production scheduler at my company, so in terms of being a “leader” for one of the management sectors I’ve taken on planning for some of these projects. I think one of the… Read more»

njq3 replied to the topic "Vendor Decision" -

Mon, 18 Apr 2022 00:29:12 -0400

My decision in the mini-sim was to go with only one other vendor. The ask was for at least one other vendor to source the coating from for the project therefore I thought it unnecessary to look for 2 other… Read more»

njq3 replied to the topic "How to speed up the problem-solving process" -

Mon, 11 Apr 2022 01:55:18 -0400

I think I would ask my team where we think the roadblock is coming from and see what I can do to help the situation. Problem solving sometimes is best done as a group and I wouldn’t want my team… Read more»

njq3 replied to the topic "Premature approval and rushing products to market" -

Mon, 11 Apr 2022 01:33:22 -0400

While I understand companies wanting to rush timelines and get their products out to market and – as @mmd55 said above – especially in medical devices where a new device might be life or death for a patient, there needs… Read more»

njq3 replied to the topic "This Week's Simulation 3" -

Mon, 11 Apr 2022 00:05:25 -0400

Personally I don’t think reprimanding or punishing the employee is the correct way to go about it, I think there should be a meeting to discuss how to best remedy the situation between the appropriate parties. What’s done is done,… Read more»

njq3 replied to the topic "Success Rate of Projects" -

Mon, 28 Mar 2022 00:24:34 -0400

I think in terms of “success” we want to consider all projects as successful whether they were seen to full completion or not. Ultimately, a project should yield some sort of learning or value to be applied to other projects…. Read more»

njq3 replied to the topic "Negative Schedule Variance" -

Mon, 28 Mar 2022 00:16:51 -0400

In terms of getting back on track, I would talk to my team about where our gaps are and why we are falling behind. Most of the time, it is because there are other priorities or there is a roadblock… Read more»

njq3 replied to the topic "Making connections between people and schools" -

Mon, 28 Mar 2022 00:11:51 -0400

Hello everyone,
My name is Nicholas Quon, I’m currently a Master’s non-thesis option in Biomedical Engineering (bachelors in Chemical Engineering) and I am currently working at L’Oreal Piscataway as a Production Scheduler. Add me on LinkedIn!
https://www.linkedin.com/in/nicholas-quon-50a556150/

njq3 posted a new topic "How poor planning affects a project" -

Mon, 14 Mar 2022 01:16:33 -0400

While planning a project is one of the first phases, it’s extremely important. Poor planning can mean execution can go all wrong and put severe delays on the timeline, even resulting in cancellation. Do you have any experiences where you… Read more»

njq3 replied to the topic "Weighing Input of the Timeline" -

Mon, 14 Mar 2022 01:06:35 -0400

In my opinion, the person who is going to have the most influence on the project timeline is going to be the company director/department director who is overseeing the project. Team members and stakeholders are going to have their input… Read more»

njq3 replied to the topic "Difference in communication when working from home" -

Mon, 14 Mar 2022 00:56:15 -0400

As someone who just recently transitioned to working from home after working in the manufacturing environment for most of the pandemic, I’ve learned how to adapt to the era that we are currently in. Most meetings are online now through… Read more»

njq3 replied to the topic "Supply Chain and Project Management" -

Mon, 07 Mar 2022 00:56:14 -0500

I currently do not work in the medical device industry but the cosmetics industry, where supply chain management is so crucial to keeping production going. I think with some of the changes to our supply chain processes, we are entering… Read more»

njq3 replied to the topic "Communication during a project management" -

Mon, 07 Mar 2022 00:50:55 -0500

At work, we use Microsoft Teams to set up meetings, calls, and various group chats. However like everyone else who has commented already I’ve used GroupMe, Facebook, even email threads going back and forth to communicate with team members. I… Read more»

njq3 replied to the topic "Career Path to becoming a project manager" -

Mon, 07 Mar 2022 00:45:00 -0500

I will play devil’s advocate here and say that it is just as beneficial to start out on management than it is starting out on the technical side. I think there is value to whichever side. While yes it’s great… Read more»

njq3 replied to the topic "Project Planning" -

Mon, 28 Feb 2022 00:36:46 -0500

I believe it’s important to set a glidepath for key deliverables to also be completed, which can even be done in the beginning of the project timeline. This will let the team know what you expect week after week or… Read more»

njq3 replied to the topic "Unique Project Challenges for Medical Device Companies" -

Mon, 28 Feb 2022 00:33:20 -0500

I think one of the biggest challenges is when developing a novel device, you have to answer to the FDA and the corresponding regulatory agency for your device, and it can be months and months (even years) of trials and… Read more»

njq3 replied to the topic "Importance of Stakeholders" -

Mon, 28 Feb 2022 00:27:35 -0500

I personally feel that yes while investors are important for funding and direction – managers are responsible for the execution. You will not have a successful project without a successful manager. You may have a lot of stakeholders and investors… Read more»

njq3 replied to the topic "Sizes of Project Teams" -

Mon, 14 Feb 2022 02:31:11 -0500

I think working with smaller teams is easier. You’re better able to communicate with everyone and ensure everyone is on the same page whereas with larger teams some things may get lost. I went from a large team (working with… Read more»

njq3 replied to the topic "As a project manager, how would you handle underperforming team members?" -

Mon, 14 Feb 2022 02:18:22 -0500

Have a conversation with the team member to address their performance. Ask them if they need support in some areas. What is holding them back? I find it’s better to be supportive rather than aggressive. Even if someone shows that… Read more»

njq3 replied to the topic "Project Deadlines" -

Mon, 14 Feb 2022 02:14:17 -0500

In my opinion and what I’ve seen work very well is projects that have very clear outlined action items for everyone to complete, in order to make sure the project gets done in a timely manner. For long-term projects, weekly… Read more»

njq3 replied to the topic "Leaders: Nature or Nurture?" -

Sun, 06 Feb 2022 23:44:51 -0500

Personally having been in a role of leadership at my current company – I never thought I was the “boss” type. I didn’t ever think I would fit into a managerial role, but having had the experience to work as… Read more»

njq3 replied to the topic "Career Decisions: Managerial Vs. Technical Tracks" -

Sun, 06 Feb 2022 23:39:45 -0500

Having been in both roles (at an almost interchangeable rate) – I think there are pros and cons to both, and I do believe that having experience in both a managerial and technical role makes you all the more appealing… Read more»

njq3 replied to the topic "Verification and Validation" -

Sun, 06 Feb 2022 23:35:15 -0500

Verification is more of an internal process where project qualities are checked in order to ensure adherence to certain specifications that are determined by project managers or directors. This can also mean that we are verifying if a certain aspect… Read more»

njq3 replied to the topic "FDA Responsibilities" -

Fri, 28 Jan 2022 17:04:18 -0500

In my opinion, the overall responsibility of the FDA to ensure all drug/food/medical devices meet current regulatory and safety requirements is a super important one. Without the FDA, we cannot guarantee that some of the medicines or food we buy… Read more»

njq3 posted a new topic "How to manage priorities in Project Management?" -

Fri, 28 Jan 2022 17:04:17 -0500

njq3 replied to the topic "How would you handle team conflict as a Project manager?" -

Fri, 28 Jan 2022 17:04:17 -0500

It is tricky to resolve conflict within a team as a Project Manager. I feel as though it’s difficult to take “sides” in a conflict as you may be causing an even greater rift in the team which will not… Read more»