https://medicaldevicecourses.com/members/rgp29/activity/ Activity feed for Roberto Pineda. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 1749c56fdacd4fc6994b6be255681b71 https://medicaldevicecourses.com/activity/p/12555/ Wed, 15 May 2019 16:57:06 -0400 As some of the posts above mention, a lot of people leave their jobs because they simply don’t like to get used to a routine. Instead (especially in engineering fields) workers prefer to get challenged by the daily work. I…   Read more»

]]> c7db90942ef7e12a56c2b494b1efba70 https://medicaldevicecourses.com/activity/p/12554/ Wed, 15 May 2019 16:57:05 -0400 I agree with most of the posts above, in the point that you have to start in the bottom and then rise up. It is key to start as an Engineer because you will be dealing with a lot problems…   Read more»

]]> 4688d38fa70c6b353209be1f414c0e14 https://medicaldevicecourses.com/activity/p/12553/ Wed, 15 May 2019 16:57:05 -0400 You have raise a good point but I am not surprised by it. Although we are taught at school that the best workers should get the promotions, I personally even took an Engineering Ethics class on how most of these…   Read more»

]]> 948247430e15478db23b51b4b43bf108 https://medicaldevicecourses.com/activity/p/12466/ Wed, 15 May 2019 16:56:18 -0400 As explained above, the project manager is the main factor on how the motivation of the team varies as the project gets done. For example: there was this time that our team was trying to get done a very hard…   Read more»

]]> 10e293ad64462053fdf7feb949890da4 https://medicaldevicecourses.com/activity/p/12462/ Wed, 15 May 2019 16:56:16 -0400 I believe that there are a lot of things that motivate a coworker to give a good performance at work. I am surprised though that only 32% people, mentioned that they were motivated by the fair pay. I think this…   Read more»

]]> 2cc9300951bc287305cbff048a9976f9 https://medicaldevicecourses.com/activity/p/12461/ Wed, 15 May 2019 16:56:15 -0400 What motivates me more when completing my work is the impact that I am causing in society when doing my job. Our community has to continue improving in every aspect of life so I just think of how my project…   Read more»

]]> 7305996f3dc3b589441ae3be3479990c https://medicaldevicecourses.com/activity/p/12393/ Wed, 15 May 2019 16:55:35 -0400 For my capstone design project, my team and I were in charge of designing a wearable watch and an app in order to help autistic children incorporate into society. The team was doing everything on time. However we applied to…   Read more»

]]> adf8d30c786a5ea5fe0893a0f38e1a2a https://medicaldevicecourses.com/activity/p/12389/ Wed, 15 May 2019 16:55:33 -0400 Yes, you have raised a very good point, I experienced that when I was working on a project for a company called SEL. My team consisted of 4 people and we were electrifying a community really closed to our installations….   Read more»

]]> b2d14e33dce3e5088a65ae724c8105bb https://medicaldevicecourses.com/activity/p/12385/ Wed, 15 May 2019 16:55:31 -0400 When I used to do projects for an electrical engineering company, the Project Manager of the company would let me create the electrical circuit diagrams based on the location, and needs of the people in the community where I was…   Read more»

]]> 3ec5265dca197f180800093d5ee4a20b https://medicaldevicecourses.com/activity/p/12307/ Wed, 15 May 2019 16:54:43 -0400 I do think that a pathway such as the one you mentioned is followed most of the time. However, no matter how hard you try there will always be delays. From personal experience, our team was providing electrical power to…   Read more»

]]> 24d1c8381f498f2331f4dd8fae6415ff https://medicaldevicecourses.com/activity/p/12306/ Wed, 15 May 2019 16:54:43 -0400 The only design review meeting I have been present in was conducted by the leader who would be moving from point to point in the agenda. The other members would be adding important comments and/or questions to whatever points were…   Read more»

]]> 5d0b8b853f4c5d712bf85ff726e96e08 https://medicaldevicecourses.com/activity/p/12305/ Wed, 15 May 2019 16:54:42 -0400 In my personal experience as an electrical engineer, I have used the technique of mitigating the risk multiple times when connecting electric transformers in multiple communities. The company I worked for, had specific workers whose job was to make sure…   Read more»

]]> 04ff26feafbeaa9139114cc20c48d3ed https://medicaldevicecourses.com/activity/p/12192/ Wed, 15 May 2019 16:53:39 -0400 As some of my classmates stated above, the review design meetings I have been involved have been very fast. The lecture suggests that you send out the document some time prior to the beginning of the meeting. However, when you…   Read more»

]]> 8f0ce641b490ef95f7ced5f098f930b1 https://medicaldevicecourses.com/activity/p/12190/ Wed, 15 May 2019 16:53:38 -0400 Hello Lamiaa, you have brought up a very good point. In my personal case, I have not dealt with any of those problems, however a close friend who works in the accounting department of a company mentioned to me that…   Read more»

]]> afa088279260eccbabc373b50fb8f220 https://medicaldevicecourses.com/activity/p/12154/ Wed, 15 May 2019 16:53:20 -0400 You have raised a very interesting point, before taking this class I did not know all these terms, I used to only say that we were under budget, ahead/behind schedule, etc. In my particular case, during my capstone project, my…   Read more»

]]> 4370c135d42252c0dd535f9a6171ff03 https://medicaldevicecourses.com/activity/p/12104/ Wed, 15 May 2019 16:52:49 -0400 I can see that the scenario you are bringing up is similar to the one in the mini sim 2. Personal differences will always occur, but the as a Project Manager you need to make all your team aware that…   Read more»

]]> 024c19c7b04f21bae2c0216bb99eb6e5 https://medicaldevicecourses.com/activity/p/12103/ Wed, 15 May 2019 16:52:49 -0400 You have brought up a very interesting point. There will always be obstacles when doing international business/projects. However, the difficulty of overcoming some will be harder than others. For example: Language could typify a high obstacle between the countries trying…   Read more»

]]> a284342238861c8bc41bb387ac8d669d https://medicaldevicecourses.com/activity/p/12009/ Wed, 15 May 2019 16:51:56 -0400 Hello, I understand the point you are trying to bring up. There is no doubt that the real business does not happen when a customer decides to choose your company to do a project, the real business happens when that…   Read more»

]]> a9d7e0adeda35567ffcc665c9139e65f https://medicaldevicecourses.com/activity/p/12007/ Wed, 15 May 2019 16:51:55 -0400 Being a project managers is not easy, it is a position that requires a lot of experience, responsibility and good organization skills. My boss is a project manager with a very broad experience in Electrical Engineering projects. There was this…   Read more»

]]> 4043bccf1374ac9b901a88230a2c775b https://medicaldevicecourses.com/activity/p/12006/ Wed, 15 May 2019 16:51:54 -0400 As an undergraduate student here, I never talked about the FDA from my freshman to junior years. However now in my senior year I have been able to understand how projects are actually done in the Industry because of this…   Read more»

]]> ddd011f092f419406a114a6a9df1b11f https://medicaldevicecourses.com/activity/p/11923/ Wed, 15 May 2019 16:51:03 -0400 Hello, There was one time that my team had placed leads in certain places of torso, legs and ankles in order to track the leads using a tracking program. The purpose of this was to collect data in order to…   Read more»

]]> d878d94e89991a0dd07feb2caa4861ef https://medicaldevicecourses.com/activity/p/11922/ Wed, 15 May 2019 16:51:02 -0400 You have raised a very good point. I have to say that WBS is probably one of the top 3 most important aspects when doing a project. The projects I did was for a small company and therefore knowing the…   Read more»

]]> 233877503dad3a3039ed5aaf2ea8c025 https://medicaldevicecourses.com/activity/p/11921/ Wed, 15 May 2019 16:51:02 -0400 Hello, for my capstone design project, my team was in charge of developing an app for autistic individuals. The app would be created in an android system and it would connect via Bluetooth to a watch (which we develop). The…   Read more»

]]> 953a57060434ce34dece51ecf012093d https://medicaldevicecourses.com/activity/p/11867/ Wed, 15 May 2019 16:50:30 -0400 I believe budget cut would affect all the phases of the project. When you are initiating it if you require $10,000 in order to develop and assemble the final product but you only have $6,000 for the project then the…   Read more»

]]> a76311d90daf6e914a437e95127c4a52 https://medicaldevicecourses.com/activity/p/11866/ Wed, 15 May 2019 16:50:30 -0400 For my Capstone Design class, my team was in charge of developing a wearable watch for autistic kids. This watch would be connected to an Android app which would be developed by us as well. The purpose of this product…   Read more»

]]> e1ba8cb4b977300ffc5743603ce51330 https://medicaldevicecourses.com/activity/p/11746/ Wed, 15 May 2019 16:49:20 -0400 Hello jp582, I agree with the stages that you mentioned. I think it is key that are done the way they are supposed to be. However I think that these steps can compressed to planning, executing and sometimes presenting. The…   Read more»

]]> 6300603fe5aa899ef0968026536016cb https://medicaldevicecourses.com/activity/p/11745/ Wed, 15 May 2019 16:49:19 -0400 Hello eac25, you have brought up a very interesting point. I agree that the FDA sometimes takes a long process in order for it to be used in the market. However I also believe that safety is more important than…   Read more»

]]> 8e6ca81c33fa2e83a63871ee5c611165 https://medicaldevicecourses.com/activity/p/11681/ Wed, 15 May 2019 16:48:41 -0400 Hello, you have raised a very interesting point. I believe that this cycle happens for all kinds of products. However as you mention, for some of them it’s really hard to see their decline. I think that all products will…   Read more»

]]> b8a5aeb7c3ee25d121109576db010a13 https://medicaldevicecourses.com/activity/p/11680/ Wed, 15 May 2019 16:48:40 -0400 Although the example that I will provide is more related to electrical engineering, I hope it helps you understand verification and validation in a better way. The company I used to work for was in charge of a project involving…   Read more»

]]> 558236b237b2b4f6ca9318c831b75f97 https://medicaldevicecourses.com/activity/p/11579/ Wed, 15 May 2019 16:47:50 -0400 This is very interesting. I had never heard of it so thank you for bringing it up. In respect to your question, all biologics fall into the CBER department. The regulation process required for the FDA would be IND, Phase…   Read more»

]]> 03eff30f43f57bb09af5bb46ced4066b https://medicaldevicecourses.com/activity/p/11578/ Wed, 15 May 2019 16:47:49 -0400 I think that they are very similar in the role developed, with the only difference that a project manager covers any project. For example: he/she could lead and execute the construction of a building or the development of a new…   Read more»

]]> 3e4e9ac147989332a0c10a2a1d690ee6 https://medicaldevicecourses.com/activity/p/11495/ Wed, 15 May 2019 16:45:26 -0400 Hello everyone, My experience in the Industry is mostly in the Electrical Engineering Industry. As I mentioned in my previous post, I work as a Project Manager Assistant. My undergraduate track here at NJIT is Instrumentation, so it has truly…   Read more»

]]> 0c623b5d44cd7ae17ca6d568af4c6a81 https://medicaldevicecourses.com/activity/p/11493/ Wed, 15 May 2019 16:45:25 -0400 Hello everyone, I have worked in a small Electrical Engineering company that sells all kinds electric products such as motors, transformers, solar and wind power generators. The company has a store where customers come in and out, but it also…   Read more»

]]> 1dfd5322d980403e886914d53e40e3c2 https://medicaldevicecourses.com/activity/p/11491/ Wed, 15 May 2019 16:45:24 -0400 Hello everyone. As Dr. Simon mentioned in the lecture, the 5 areas of emotional intelligence represent a good project manager. However if I had to add other skills to these 5 areas, I would add strong communication skills and responsible….   Read more»

]]> 52a704a3e14c47b92cc543e569de9dea https://medicaldevicecourses.com/activity/p/11357/ Wed, 15 May 2019 16:44:11 -0400 I would never agree with someone using a “verbal agreement” because if you don’t have a written contract of what everyone is supposed to do, a lot of problems will arise and lawsuits might take place, but if have a…   Read more»

]]> a2ef6b3c0693654624cddaf8c7f22682 https://medicaldevicecourses.com/activity/p/11356/ Wed, 15 May 2019 16:44:11 -0400 Dr Simon, At the beginning of the semester, I was not sure if I was going to stay in the class due to having so many courses this semester. But as the lectures started, I understood that this course is…   Read more»

]]> 036741c4667362a6391017edf494226b https://medicaldevicecourses.com/activity/p/11255/ Wed, 15 May 2019 16:43:22 -0400 Very interesting point lamiaa. I believe that it will be more challenging for project managers to work in matrix organizations because they have cross the limits that the departments set and deal with people that you have never talked to…   Read more»

]]> 829443dfcbc255a9e38fec48ec8111a4 https://medicaldevicecourses.com/activity/p/11254/ Wed, 15 May 2019 16:43:22 -0400 I worked in a small project where the owner of the company was the one who chose the team. The most important criteria used was that they needed to be hands on individuals who executed the project as neat as…   Read more»

]]> ada43c203be904d82bc8601e1511bbb2 https://medicaldevicecourses.com/activity/p/11253/ Wed, 15 May 2019 16:43:21 -0400 In my previous experience, it was more like functional organization. I used to work in a small business where there was a lot of work for a few employees. However, all the projects were done by the same department because…   Read more»

]]> dff82b77062157fdaf1903a026ad49e5 https://medicaldevicecourses.com/activity/p/11093/ Wed, 15 May 2019 16:39:50 -0400 These costs have a bigger impact in those companies that are just starting and don’t have a big budget. Big company have no problem with paying a lot of money for it because they have a big budget. The FDA…   Read more»

]]> 2c92a6ed58461d3b791fc90d529e90fe https://medicaldevicecourses.com/activity/p/11092/ Wed, 15 May 2019 16:39:50 -0400 Another good technique that is used in the Industry is: Failure Mode Effects Analysis (FMEA) This technique analyses the outcomes of a failing project. First you establish the failure modes, then risk reduction is used in order to increase the…   Read more»

]]> fe178ba83077844a5c6109384ebfdb2d https://medicaldevicecourses.com/activity/p/11091/ Wed, 15 May 2019 16:39:49 -0400 In personal experience, the design matrix is the most important part of the risk management analysis. The way it was done in a job I had, was by how much money the owner of the company was going to make….   Read more»

]]> 6a9695d90f0c96c3d6f9b35320f0fb66 https://medicaldevicecourses.com/activity/p/10947/ Wed, 15 May 2019 16:38:12 -0400 I agree with most of the challenges mentioned above by my classmates. However I have to point out that the main two challenges(In my opinion) should be safety issues and communication problems between all the departments working on the device….   Read more»

]]> 468363c273661d0da29276c6fc36161b https://medicaldevicecourses.com/activity/p/10878/ Wed, 15 May 2019 16:37:29 -0400 The whole team is in charge of launching a product to a target customer. You gotta to have certain a target customer, people who are willing to use the product. The project manager would then put together all the documents…   Read more»

]]> 2ddb1b7989ef930af5a595479b937372 https://medicaldevicecourses.com/activity/p/10877/ Wed, 15 May 2019 16:37:28 -0400 The timeline done by the project management would be significantly changed. A poor product would bring down the credibility of the company and it would put in risk the safety of the patients (Additionally, if the project affects the person,…   Read more»

]]> d1dbbedc8ca1ec0f667a9363d842a42e https://medicaldevicecourses.com/activity/p/10875/ Wed, 15 May 2019 16:37:26 -0400 The main reason why Design controls are useful is because they test the quality, liability of the product. This would make sure that the clients do no get affected in a bad way by it. On the same way, it…   Read more»

]]> 41eb683eb9d286ccfcffaa7a065962bb https://medicaldevicecourses.com/activity/p/10481/ Wed, 15 May 2019 16:33:53 -0400 In this week’s lecture Dr. Simon mentioned that during the executing process of a project, the project manager (PM) is in charge of the source selection. This means the PM must decide on who are the appropriate suppliers for the…   Read more»

]]> 5a719cf8c9cda94370b66453c8fc25ad https://medicaldevicecourses.com/activity/p/10451/ Wed, 15 May 2019 16:33:40 -0400 Hello everyone. Project managers need to be effective in a lot of ways. For example, you need to finish the project on time and the quality of the product need to be outstanding. However, they don’t do it alone. They…   Read more»

]]> 06940383b1abaaf154d878d120c0237d https://medicaldevicecourses.com/activity/p/10444/ Wed, 15 May 2019 16:33:37 -0400 Hello everyone, I hope everything is going well. Dr. Simon mentioned in the lecture that you during the design verification and validation phase, the engineer is supposed to kind of “make up a test.” I am completely sure that all…   Read more»

]]> 8263d11b2221022c4b5535b80da0a2ab https://medicaldevicecourses.com/activity/p/10432/ Wed, 15 May 2019 16:33:31 -0400 In the lecture Dr. Simon mentioned that if your device posses a significant risk the FDA might require clinical trials. I know there are other reasons for why a product might require clinical trials but what is meant by “significant…   Read more»

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