Medical Device Courses | kss69 | Activity

kss69 replied to the topic "Job Satisfaction" -

Tue, 25 Apr 2023 20:24:18 -0400

Is financial compensation the primary motivator for employees, or are there other non-monetary factors such as job satisfaction, recognition, and work-life balance that play a greater role in driving motivation and productivity? I do not believe this to be… Read more»

kss69 replied to the topic "What’s Your Motivator?" -

Tue, 25 Apr 2023 20:15:38 -0400

I am most motivated by the amount of work I have to do. I find that on weeks when I don’t have many assignments due, I’m taking forever on one assignment. But on weeks when I have a lot of… Read more»

kss69 replied to the topic "Why Do People Leave?" -

Tue, 25 Apr 2023 20:09:13 -0400

I think this is a significant factor in employee retention and productivity because you have to like what you do because if you don’t it will start to become a drag and you won’t enjoy it; decreasing productivity and overall… Read more»

kss69 replied to the topic "Quick, Fast, Good? Pick Two" -

Tue, 18 Apr 2023 21:30:27 -0400

I think the two I would choose are good and fast; though this would be pricey and possibly not cost-effective. Fast so the product can hit the market faster and start to make a difference. Good because I would hate… Read more»

kss69 replied to the topic "Priorities for Projects" -

Tue, 18 Apr 2023 21:23:25 -0400

I have found that every week someone else tells me another project is a priority, so often I need to sit down with my manager and prioritize the priorities because so many projects need to be completed. We like to… Read more»

kss69 replied to the topic "Vendor choice." -

Tue, 18 Apr 2023 21:17:04 -0400

In my experience, I have found that if you stick to the specification and allow for very minimal leeway, the product coming in will always be just as you need. However, this can take multiple iterations of the product being… Read more»

kss69 replied to the topic "Specifications: A double edged sword?" -

Tue, 11 Apr 2023 21:37:20 -0400

In my experience, when formulating brand-new specifications, many individuals draft a document, then send it to the supplier to see if it is feasible for them. If yes, then a contract can be made. If not, then they set up… Read more»

kss69 replied to the topic "Deadlines and SOP's" -

Tue, 11 Apr 2023 21:31:02 -0400

In my opinion, solely relying on reaction is bad. However, the concept of reactive managing is needed. Because reactions can move into becoming preventions. If there is a repeated failure of something in the documentation and it is being seen… Read more»

kss69 replied to the topic "Vendor Decision" -

Tue, 11 Apr 2023 21:25:27 -0400

I made the decision to have a backup. I believe it’s a bad practice only to have one source for anything, especially something critical that belongs to your device. From past experiences, many issues arise and people rush to get… Read more»

kss69 replied to the topic "Lessons Learned" -

Fri, 07 Apr 2023 19:36:19 -0400

I think the reason lessons learned is always documented is so the mistakes are not repeated. Additionally, this can attribute to any preventative actions that can be implemented in proceeding projects. The objective is always to learn from your mistakes,… Read more»

kss69 replied to the topic "Initiating Process Group" -

Fri, 07 Apr 2023 19:30:33 -0400

I agree with @Jbarbee that the organizational process assets should contain that information. Additionally, I think all these processes come from the previous experience of any project manager. Many take a template and populate or edit it in such a… Read more»

kss69 replied to the topic "Supply Chain and Project Management" -

Fri, 07 Apr 2023 19:03:48 -0400

In my experience, the company I used to work at often pushed the employees to double production output. This was a goal from upper management and in order to achieve this goal, the employees needed to work much harder than… Read more»

kss69 replied to the topic "Different results from each test companies." -

Fri, 24 Mar 2023 21:35:06 -0400

In my experience, we have run into this problem exactly where the product was not passing our validation and verification protocols but it was passing the supplier’s verification and validation protocols. In these cases, what we have done is set… Read more»

kss69 replied to the topic "monitoring phase of a project" -

Fri, 24 Mar 2023 21:27:51 -0400

The exact limit always depends on the intensity and urgency of the project as @Dke2 mentions. Urgent and business-critical projects should have meetings every week to ensure everything is on track to be completed by the due date. Less urgent… Read more»

kss69 replied to the topic "Project managers' previous experiences" -

Fri, 24 Mar 2023 21:18:27 -0400

I think in today’s rapidly moving and ever-changing society, adaptability is more favorable. In my experience, there are many instances where upper management views an issue and all resources need to be diverted onto that issue in order to get… Read more»

kss69 replied to the topic "Difference in communication when working from home" -

Wed, 08 Mar 2023 00:28:13 -0500

I feel like the pandemic brought about needed changes in the way many companies were running. Many companies and employees found out that production and work output barely changes when employees are working at home. This causes a shift in… Read more»

kss69 replied to the topic "Points to look for while out sourcing" -

Wed, 08 Mar 2023 00:22:49 -0500

In my experience working, when looking for another supplier, my team would often send the blueprints to the supplier and ask them to make a small batch, which then we would inspect for the critical dimensions. This way we can… Read more»

kss69 replied to the topic "Making connections between people and schools" -

Tue, 07 Mar 2023 23:53:22 -0500

Hi everyone,

Here is my LinkedIn page: https://www.linkedin.com/in/karma-shah-a6a8b0178/
I look forward to connecting with you!

kss69 replied to the topic "Penalization for Going Over Budget and Time?" -

Tue, 28 Feb 2023 23:25:51 -0500

In many companies, it is said that if the company is not doing well then the employee’s bonus will be affected at the end of the year. This can be used as a penalization method; however, in my experience, if… Read more»

kss69 replied to the topic "Assessing & Evaluating Risks of a Medical Device" -

Tue, 28 Feb 2023 23:15:10 -0500

In my experience, I have found that many times to create a brand new DFMEA, old ones from other devices are pulled. If the specific line item cannot be found in other DFMEAs, @sin3 mentions a good way to look… Read more»

kss69 replied to the topic "Engineering change order" -

Tue, 28 Feb 2023 22:52:40 -0500

i agree with many of the posts above about how ECO’s are a good way to address an issue and mitigate the problem before it becomes any worse. I also believe this can be taken a step further. To sell… Read more»

kss69 replied to the topic "Organizing tasks" -

Fri, 24 Feb 2023 04:29:07 -0500

I believe this is a good visualization method, however, it has no concrete implications. With that being said, many companies follow a motto which is “if it is not on a controlled document, it didn’t happen”. This phrase comes especially… Read more»

kss69 replied to the topic "Problem with the Vendors" -

Fri, 24 Feb 2023 04:20:54 -0500

In my experience of working, this issue has happened a lot. There are various routes to take to address this. There can be a project initiated to address nonconforming aspects of the items shipped in because they do not adhere… Read more»

kss69 replied to the topic "Design Review Meeting" -

Fri, 24 Feb 2023 04:12:47 -0500

In my experience working in the industry, I often took part in design review meetings. Many of the meetings resulted in a change in the design or part of the design. I expected it to be more like a meeting… Read more»

kss69 replied to the topic "Risk vs. Reward" -

Wed, 15 Feb 2023 00:01:46 -0500

Working in the industry has taught me that most projects that are associated with high risk will take time and resources to mitigate that risk. In many instances, low risks are often accepted. For example, one of the projects I… Read more»

kss69 replied to the topic "The best strategy in running Risk Management Meeting" -

Tue, 14 Feb 2023 23:50:23 -0500

Being a part of a team that handles various projects at a time, I have encountered and discussed many risks associated with my projects as well as my team’s. One key aspect is to have all the projects, the stage… Read more»

kss69 replied to the topic "Risk Management Selection" -

Tue, 14 Feb 2023 23:27:09 -0500

I think @mb698 explains it really well as to the importance of the Risk Management Team being the same as the Project Management Team. I also believe that @ jl959 points out an important aspect of the delays that this… Read more»

kss69 replied to the topic "Determining Spec" -

Wed, 08 Feb 2023 23:12:08 -0500

In my experience, a lot of specifications have a tolerance enough where the manufacturer is able to make the product well and it doesn’t compromise the integrity or functionality of the product. In certain cases, there have been instances in… Read more»

kss69 replied to the topic "Package Development Testing & Documentation" -

Wed, 08 Feb 2023 22:56:05 -0500

As @ala26 mentions, I’ve seen some sterility and integrity tests as well as the burst tests referred to by@hc255. However, in my experience, I have seen additional tests that do not only comment on the integrity of the box but… Read more»

kss69 replied to the topic "Determining project priority" -

Wed, 08 Feb 2023 22:35:23 -0500

I agree with @aij5 in that the most important factor is the patient market and identifying which projects have a significant effect on that. In my experience, there are some projects that are very much business-critical and require a lot… Read more»

kss69 replied to the topic "Emotional Intelligence" -

Tue, 31 Jan 2023 23:34:56 -0500

I’ve had the luxury of being on many different teams where I used to work and a part of that is meeting and working with new people almost every day. Most of which, I would not have known or gotten… Read more»

kss69 replied to the topic "How do you set up a project organization?" -

Tue, 31 Jan 2023 23:14:41 -0500

I think the most effective is the Matrix style; although it has disadvantages such as having multiple managers as well as scheduling conflicts. If I were a team leader, I would use the matrix style the best as it incorporates… Read more»

kss69 replied to the topic "Career Decisions: Managerial Vs. Technical Tracks" -

Tue, 31 Jan 2023 22:57:40 -0500

I’ve had to make the decision to move from a technical track to more of a managerial track. To quickly touch on @nk434, the transition was not as bad as I thought it would be. I wanted to pursue technical… Read more»

kss69 replied to the topic "Roles of the Regulatory Department" -

Thu, 26 Jan 2023 22:35:08 -0500

I would want to work in post-market management as I believe this offers the most opportunity. I can take the feedback from the market and bring it to the product development team and help them work on improvements and help… Read more»

kss69 replied to the topic "Leaders: Nature or Nurture?" -

Thu, 26 Jan 2023 22:23:32 -0500

I agree that primarily people are influenced by their experiences and how they were raised being the most influential aspect of being a leader as a project manager. Primarily because your personality and traits are heavily influenced by what you… Read more»

kss69 replied to the topic "FDA ethics" -

Wed, 25 Jan 2023 01:25:09 -0500

When objectively looking at the FDA claim, I do not believe this to be unethical. I feel like the same argument can be made about any item meant for consumption, that too much of it is not safe. I do… Read more»

kss69 replied to the topic "Sizes of Project Teams" -

Tue, 24 Jan 2023 15:45:08 -0500

I believe working in a smaller group is more effective as there are fewer moving parts between individuals. In my experience, in larger groups, there are more ideas that get presented because of everyone’s experience. Then as time progresses, it… Read more»

kss69 replied to the topic "Understanding your role..." -

Tue, 24 Jan 2023 15:45:08 -0500

I believe as soon as a project is assigned or available, everyone should meet and identify the aspects that are important to completing the project and assign roles to individuals based on that. Therefore, the roles of the project are… Read more»

kss69 replied to the topic "How would you handle team conflict as a Project manager?" -

Tue, 24 Jan 2023 15:45:08 -0500

Team conflict is almost inevitable as people are always eager to pitch their idea and have their idea be the one implemented. In the case conflict does happen, the proper solution is to speak to both parties and then have… Read more»