Medical Device Courses | cm539 | Activity

cm539 replied to the topic "Engineer vs. Manager" -

Tue, 26 Apr 2022 19:51:41 -0400

I want to be an engineer or a scientist. I love to build projects and problem solve. I also recently had the opportunity to be involved with research for the first time during my thesis and I absolutely loved it…. Read more»

cm539 replied to the topic "How to manage and train low performers in common companies?" -

Tue, 26 Apr 2022 19:43:04 -0400

I feel the first step would be to determine why an employee is underperforming. Do they lack skills or are they unhappy in the work environment? If this employee shows they are willing to learn and grow, one on one… Read more»

cm539 replied to the topic "Skills Learned in this Class" -

Tue, 26 Apr 2022 19:32:02 -0400

I learned that working on a team may not always be sunshine and rainbows. I can’t expect to have others to be at the same level as me, in terms of motivation, time management, or drive. I found that people… Read more»

cm539 replied to the topic "How was this class helpful" -

Mon, 18 Apr 2022 23:47:36 -0400

I took another one of Dr. Simon’s classes last semester, which was similar to this one. I decided to take BME682 because I felt I didn’t quite grasp the concepts the first time. I feel I understand the process of… Read more»

cm539 replied to the topic "Overworked Americans vs. Motivation" -

Mon, 18 Apr 2022 23:29:44 -0400

I feel Americans are overworked because they want a good life. Their motivation, I believe, is money and not necessarily competition. Who wouldn’t want to live comfortably without any worries? The cost of living in the US can be expensive… Read more»

cm539 liked forum post "Overworked Americans vs. Motivation" -

Mon, 18 Apr 2022 23:27:39 -0400

cm539 replied to the topic "What’s Your Motivator?" -

Mon, 18 Apr 2022 23:15:44 -0400

Acquiring new skills and knowledge motivates me to keep pushing my boundaries. I love a good challenge and always strive to learn something new. I see so many different career paths unrelated to engineering, and I just wish I could… Read more»

cm539 replied to the topic "Potential PM?" -

Thu, 14 Apr 2022 21:34:36 -0400

I do not think I would become a project manager. It appears too demanding for me and if the project fails, it’s all reflected on me. I would be much happier as one of the team members. After some experience… Read more»

cm539 replied to the topic "Changining staff" -

Thu, 14 Apr 2022 21:29:07 -0400

I would imagine this would not be a surprise. Most people are kind enough to give a notice for when they are leaving. This will allow the project manager to fill this position or distribute the workload throughout the rest… Read more»

cm539 replied to the topic "QA vs QC" -

Thu, 14 Apr 2022 21:19:48 -0400

Quality assurance (QA), quality control (QC), and quality planning fall under quality management. These three processes work together to ensure the product is to standards. QA ensures the regulations are being followed. In other words, they help to prevent failures…. Read more»

cm539 replied to the topic "Testing" -

Tue, 05 Apr 2022 15:29:31 -0400

When I like to tackle a challenge, I find it very helpful to alter one variable at a time. In this simulation, by changing the packaging and medicine at one time, a concrete solution could not be determined if this… Read more»

cm539 replied to the topic "Improving Team Performance" -

Tue, 05 Apr 2022 15:19:36 -0400

I would first hold a team meeting, as many others before me have said. At this meeting, I would ask questions that pertain to goals or tasks the previous project manager has put into place. This will generally give me… Read more»

cm539 posted a new topic "Medical Device Companies" -

Mon, 04 Apr 2022 21:52:38 -0400

Since a lot of us will be heading into the workforce soon, if you haven’t already, I think it would be helpful if we shared about medical device companies within this region of the US. What are some companies… Read more»

cm539 replied to the topic "Project Changes" -

Mon, 21 Mar 2022 20:26:33 -0400

After reading many of these replies, it seems as if these changes occur frequently, especially ECO. I wonder what the ratio would be if we compared projects that did not need a change compared to ones that went through one… Read more»

cm539 replied to the topic "kinds of changes in PM" -

Mon, 21 Mar 2022 20:16:05 -0400

The types of changes noted in this week’s lecture vary based on what phase of design controls the project is in. Ordering them from beginning stages to completion would be: 1. Non-essential design change (NDC), 2. Design change number (DCN),… Read more»

cm539 replied to the topic "Making connections between people and schools" -

Mon, 21 Mar 2022 19:52:42 -0400

Hello everyone,
Here is my LinkedIn page: https://www.linkedin.com/in/cassandra-martin-720126194/

Looking forward to making some great connections!

cm539 replied to the topic "In planning, the method to calculate each task duration." -

Sun, 13 Mar 2022 21:09:24 -0400

Using timelines from previous projects can provide the team with a general idea of the duration of a particular task. Some task durations can be accurately accounted for and others not so much. Things like manufacturing and shipping have time… Read more»

cm539 replied to the topic "Verification Test" -

Sun, 13 Mar 2022 20:57:21 -0400

As the others above have stated, verification tests are designed so that they do fail. Learning from mistakes allows for growth and sometimes, a product may fail in a way you have not anticipated. The process of verifying inputs =… Read more»

cm539 replied to the topic "Difference in communication when working from home" -

Sun, 13 Mar 2022 20:42:35 -0400

Overlapping of the work and life environment happen, but I believe that they should try to remain separate or at least with little overlap. When working from home, the boundaries are up to each individual and strategies on keeping them… Read more»

cm539 replied to the topic "Penalization for Going Over Budget and Time?" -

Sat, 05 Mar 2022 21:14:05 -0500

I feel that there is no blanket answer but let’s assume the project had a strict deadline with only so much funding. Since this is quite realistic, I believe punishment is necessary. The degree should depend on how much experience… Read more»

cm539 replied to the topic "Communication during a project management" -

Sat, 05 Mar 2022 21:02:48 -0500

Interesting you mention “Slack” I had just recently heard about it in the lab I am currently working in. Although I still am new to the app, I find that it is very helpful. We mostly use it as a… Read more»

cm539 replied to the topic "Project Slack Time" -

Sat, 05 Mar 2022 20:57:06 -0500

Incorporating slack into a project allows for some leeway if a part of the project takes longer than expected. Often times the project can still be completed on time. I would consider it to be important because some variables such… Read more»

cm539 replied to the topic "From a Stakeholders Point of View" -

Tue, 22 Feb 2022 21:04:59 -0500

They should absolutely not be involved with anything other than financials. The other areas should be left to those professionals. Having the stakeholders more involved in the project leads to too many cooks in the kitchen. It should be: here… Read more»

cm539 replied to the topic "Organizing tasks" -

Tue, 22 Feb 2022 20:52:43 -0500

This is a very good method for the purpose of brainstorming and visualizing the tasks. I believe it is much easier to have team members collaborate in person than virtually. Plus, the idea of moveable sticky notes lets the team… Read more»

cm539 replied to the topic "Time vs. Money" -

Tue, 22 Feb 2022 20:44:02 -0500

In my opinion, time is more valuable than money because a project that is well thought out is likely to be more successful, and therefore generate higher profits. It is like an investment; you have to spend money to make… Read more»

cm539 replied to the topic "Executing Process" -

Sat, 19 Feb 2022 23:25:38 -0500

Knowing everyone’s schedules can make the executing process go smoother when someone is absent. This will allow for slight modification to ensure their tasks are covered. If they have the ability to put more hours of work in to get… Read more»

cm539 replied to the topic "Over budget project" -

Sat, 19 Feb 2022 23:04:03 -0500

This is a situation I would not like to find myself in because it shows that my managing skills were not good, to say the least. Terminating the project at 65% completion would be a waste of money, so the… Read more»

cm539 replied to the topic "Best Processes/ Phase" -

Sat, 19 Feb 2022 22:53:02 -0500

I believe that each of the phases are important, but the planning phase may be slightly more important than the rest. This is because without very good planning, the cycle: plan > do > check > act, would not have… Read more»

cm539 replied to the topic "Different Project Manger Approaches" -

Tue, 08 Feb 2022 19:09:16 -0500

As most responses before me, I also prefer a hands-off approach because it relies on trust and lets the team have a sense of responsibility. This style gives more freedom which allows personal expression to be incorporated into the projects…. Read more»

cm539 replied to the topic "Experiments" -

Tue, 08 Feb 2022 18:32:20 -0500

First step: Determine and understand why the experiment failed. Second step: Come up with a solution and test it. Repeat as necessary. Method for resolution is all about trial and error using accurate and sophisticated possible solutions. It’s okay… Read more»

cm539 replied to the topic "Should Interpersonal skills be more valuable than technical skills?" -

Tue, 08 Feb 2022 18:20:54 -0500

Since the example @vcf3 has provided relates to biomedical engineering, I would have to say technical skills are more valuable than interpersonal skills. Certainly not the inverse they have proposed, but rather 60% on technical skills and 40% on interpersonal… Read more»

cm539 replied to the topic "Product Life Cycle" -

Thu, 03 Feb 2022 16:21:48 -0500

The product life cycle has been described for a reason and that is all products experience this growth and decline pattern over the course of its time. Yes, some experience this more rapidly than others, but I believe it is… Read more»

cm539 replied to the topic "Organization type preference" -

Thu, 03 Feb 2022 15:57:55 -0500

I prefer the structure of functional organization because it appears to be the one that has the greatest level of focus on a specific task. One leader that has the final decision is great because there is no need to… Read more»

cm539 replied to the topic "Design Controls" -

Thu, 03 Feb 2022 15:20:13 -0500

Out of the nine parts of design controls, planning has to be the most essential because this aligns the project to be successful. The design development plan includes a summary of the project, a timeline, a structure for meetings, and… Read more»

cm539 replied to the topic "How to manage priorities in Project Management?" -

Sat, 29 Jan 2022 23:04:38 -0500

I do not have experience in the field, so my answer will be in terms of group projects. In the beginning of a project, I like to sit down with the team and list our major goals. It will then… Read more»

cm539 replied to the topic "Roles of the Regulatory Department" -

Sat, 29 Jan 2022 22:48:30 -0500

Choosing between those two roles, I would choose product development because the management side of a team does not interest me. I honestly could not see myself choosing either of those positions as a career. Compiling reports, working with the… Read more»

cm539 replied to the topic "FDA ethics" -

Sat, 29 Jan 2022 21:09:50 -0500

I don’t believe that the antifreeze ingredient is unethical, but rather the lack of awareness is. I did a quick search, and I am shocked to the wide variety of products this ingredient can be found in. The chemical terminology,… Read more»

cm539 replied to the topic "How would you handle team conflict as a Project manager?" -

Sun, 23 Jan 2022 23:29:08 -0500

My approach to resolving the conflict would be the same as @jbarbee has explained. Creating a space where each person can discuss their views and ideas, would be beneficial. This, however, depends on if the conflict stems from the work… Read more»

cm539 replied to the topic "What kind of projects interest you the most?" -

Sat, 22 Jan 2022 19:42:25 -0500

I prefer difficult projects that allow me to learn new skills and to think outside the box. I would also much rather hands on projects compared to one done solely with a computer. As for the time frame, long, drawn… Read more»

cm539 replied to the topic "Team member skills" -

Sat, 22 Jan 2022 19:29:16 -0500

A team works well when all of the members get along and can put aside personal differences in the work environment. I feel that anyone could become a project manager, but may not be the best at it. It all… Read more»

cm539 replied to the topic "Written Agreement v/s Verbal Agreement" -

Sun, 28 Nov 2021 21:51:08 -0500

Verbal agreements seem fishy to me because there is no paper trail. If one would have to rely on verbal agreement, it may be good practice to have several witnesses rather than it be between two people. I would prefer… Read more»

cm539 replied to the topic "Factors to consider when executing the NDA" -

Sun, 28 Nov 2021 21:40:53 -0500

I feel there is no way to gauge about how much information is shared when one signs a NDA. It is based on who is signing the agreement. For example, a company most likely will not tell you their top-secret… Read more»

cm539 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Sun, 28 Nov 2021 21:25:22 -0500

When I signed up for this course, I had no idea what to expect. To be completely honest, I did not understand the terms in the course description because I have not had exposure to these topics. In a way,… Read more»

cm539 replied to the topic "Upper vs Middle Management." -

Fri, 19 Nov 2021 22:17:18 -0500

I would be much better suited as a middle manager because I would trust myself more creating plans to achieve the company vision than to set the vision. It’s not that I am unfit for a leadership role; I’m certain… Read more»

cm539 replied to the topic "Medical Device Project" -

Fri, 19 Nov 2021 22:01:10 -0500

So far, the project seems to be going well. We have had several meetings which were productive. Up until this point, we are at a comfortable place with the DDP, DID, and Gantt Chart. They certainly can use final touches,… Read more»

cm539 replied to the topic "Forming a Project Team" -

Fri, 19 Nov 2021 21:29:48 -0500

I prefer to have people on my team with a similar work ethic as I do. If I had to create a hierarchy of how to form a project team, this certainly would be number one. The next one would… Read more»

cm539 replied to the topic "To risk manage or not to risk manage?" -

Fri, 12 Nov 2021 18:22:25 -0500

Risk management is absolutely important for a medical device. These devices will be used on people and/or by people. I would consider it to be unethical if there was no risk management associated within the planning phase. I read this… Read more»

cm539 replied to the topic "how far is "As Far As Possible"" -

Fri, 12 Nov 2021 17:59:44 -0500

“As Far As Possible” allows medical devices that vary in use, class, and risk to be considered safe under the manufactures’ own definition. As an example, the risks for a wheelchair and insulin pump are different, however both need to… Read more»

cm539 replied to the topic "Risk management and Labels" -

Fri, 12 Nov 2021 17:40:33 -0500

I feel that labels and instructions are used as a last resort to explain the risks to the consumer. If you have ever been on medication on used common medical devices found in a drug store, chances are you have… Read more»

cm539 liked forum post "Gantt Chart Thought Process and Considerations" -

Sat, 06 Nov 2021 16:52:36 -0400