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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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/

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»

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»

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»

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»

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»

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»

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»