srg36

  • I have been working as an engineer for 3 years and enjoy what I am doing. I still am not sure if I want to take a technical or managerial career path. I think I would like to gain some more technical experience over the next several years, but I could see myself transitioning into a managerial role sometime in the future.

  • I think there is another very important aspect to this topic that I would like to bring up. I think it is important that managers recognize what type of work motivates their employees, and give them more opportunities to do that type of work. For example, if an employee really likes technical work, the manager should give that person opportunities…[Read more]

  • The division of the company that I work for only submits 510k applications, and the FDA cost associated with submitting a 510k is $10,566. In 2016, the average time to get 510k clearance was 177 days. Just recently, my company received 510k clearance for a device 65 days after submitting the 510k. However, this came as a shock to us, because it…[Read more]

  • Several of the posts above mentioned how that retention is important because new hires need time to get trained in their job, and I want to emphasize that this can have a huge impact on a project. New employees will not be nearly as efficient as experienced employees, and if there is high turnover on a project team, it will take a long time for…[Read more]

  • srg36 replied to the topic AMDD in the forum Clinical Trials for Medical Devices 3 months ago

    I agree with everyone above that I found these classes very beneficial to me, and especially the topics covered in AMDD helped me gain a better understanding of process validation. The simulations were very realistic, and overall, both MDD and AMDD give you a good picture of what it is like to work in industry. I wish classes like this were…[Read more]

  • My company recently underwent a restructuring and recently formed a new clinical department. Before this we really did not focus our efforts on clinical studies, as we were releasing products via 510ks that were similar to other products in the market and did not require a clinical trial. However, we are now looking at new materials and would like…[Read more]

  • Comparing the simulations with my experience in industry, I can say that they are very representative of what happens in industry. Often after submitting a proposed solution Dr. Simon would come back with something that we hadn’t thought about, and the entire team would be stumped for a bit, and this is exactly what happens in real life. Problem…[Read more]

  • I think there should be different levels of rewarding motivation, so team motivation should be rewarded separately from individual motivation. For example, teamwork is encouraged, but it makes sense that each individual would get rewarded differently because each person contributed a different amount to the project. However, I think there should…[Read more]

  • It is a well known fact that Americans work more hours per week on average than most other countries in the world. Do you think that Americans are putting more hours in because they are more motivated, or because they are giving in to peer pressure or just have too much work to do? Does overworking lead to demotivation?

    Personally, based on my…[Read more]

  • In my career thus far I have definitely found that challenging and interesting work created the most motivation for me, similar to the results of the poll that Dr. Simon showed in his lecture. When I first started my job, I was placed on a very challenging project that mostly consisted of putting out fires, one after the other. The project kept…[Read more]

  • srg36 replied to the topic CAPA in the forum Quality Systems Management 3 months ago

    A CAPA really just provides a systematic way for companies to address nonconformances, fix them, and prevent them from happening again. One benefit of using a CAPA to do this rather than just doing it in a haphazard manner is it makes the process much more efficient and therefore can ultimately reduce impact to product in the field. In addition, I…[Read more]

  • Based on my experience in industry, internal audits are conducted on a regular basis (usually once a year) by someone who works for the company. This is just a requirement that most companies have in their procedures and makes sure that product DHFs are in conformance with the company procedures. It is a good way to ensure that there is…[Read more]

  • I think kak33 gave a very good explanation of an effective way to bring up this topic with management. An employee needs to take the initiative to write out exactly why they think that additional headcount is needed. Like kak33 mentioned, if they have a detailed log of their day to day activities, highlighting tasks that they are unable to…[Read more]

  • I think one of the pitfalls of the WBS could be not breaking it down far enough. We learned that it is important to break down each task into subtasks and so on so that when you are completed, you have each individual task listed out. If you don’t list out every individual task, I don’t think it will be as effective, because you may miss a task…[Read more]

  • I think krp67 brings up a very interesting and important topic in regards to communication techniques and style for medical device projects, and I think many projects struggle simply because of poor communication. I think the 2 major forms of communication that should be used for a project are face to face and email. In general I agree that face…[Read more]

  • I think that a good strategy could be to select a different coating from the same supplier as a short term solution to reduce sourcing risk while keeping the project on track and not causing any delays to the project by having to go through the process of selecting and qualifying a brand new supplier, and then plan on doing this work in the future…[Read more]

  • At my company, we recently updated our design control procedures, and in the updated procedure there was a clause that said that this procedure update applied to newly chartered projects or projects where the team decided to migrate to the new version. I think it was smart that they added this statement, because it allows projects that were…[Read more]

  • As tn58 mentioned that there are three types of nonconformances: minor, major, and critical, I would also say that another huge factor that determines the type of nonconformance is when the nonconformance was found. If it was caught prior to the product being released to the field, it will greatly reduce the criticality of the nonconformance and…[Read more]

  • I agree that small companies would most likely hire an outside contractor to perform an audit if they do not have the resources to do their own internal audit. However, sometimes even larger companies hire independent contractors to perform audits, the reason being that having an outsider looking at your documentation, you are much more likely to…[Read more]

  • Similar to aij5, I have had quite a bit of experience working on ECO’s (my company calls them CCFs (Change Control Form)) for a product that my company acquired and it was already on the market. Unfortunately, it was a very cumbersome process, because in reality we were doing an NPD project under the realm of ECOs. We were creating new prints, and…[Read more]

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