What is a distributed systems engineer

System engineers in medical technology

What special requirements are placed on system engineers in medical technology? Are there any differences to other industries? As a systems engineer in medical technology, I would like to report on my experiences in this blog article.

Regulatory requirements, processes, standards and approval

Hardly any other industry has such restrictive regulations as medical technology. A system engineer needs very good knowledge here in order to be able to master projects successfully. On the one hand, it is important to know the regulatory requirements in medical technology and to understand the resulting processes. On the other hand, compliance with standards and the supervision of the approval of a medical device is a central task of the system engineer in medical technology. Experience in this area is very important here.

A systems engineer in medical technology has to create or read and approve a large number of documents. If you are at war with documents, you should look for another field of activity :-)

Basic knowledge in medicine

An engineer is not a doctor! That's a good thing. Basic knowledge in medicine is very helpful and important for the development of products in medical technology. I myself attended lectures on anatomy and physiology during my studies and am also interested in medical topics in my free time. That helps me to better assess the background to products. A systems engineer needs to have an overview of medical products and be familiar with the market and competitors. When developing a product, one often looks at competitor devices. Here you can identify good or bad concepts and design your own product accordingly. To do this, however, it is necessary to be familiar with devices from competitors. Ideally, not only from instructions for use, but also from real devices. Disassembling and analyzing competitive devices is very interesting and sometimes instructive.

Complexity and distributed teams

With a few exceptions (computer tomographs, magnetic resonance tomographs, radiation therapy), the complexity of medical technology products is not as high as in the automotive or aerospace industries. However, due to the increasing networking of products and increasing performance requirements, the complexity is now increasing noticeably. From my observation, the team sizes have quadrupled in the last 10 years. This also goes hand in hand with the fact that the teams are no longer in one location. Distributed teams are also becoming more and more important in medical technology. This situation has been around for a long time in the automotive sector. Therefore we can benefit from their experience and avoid “rookie mistakes” with distributed teams. With increasing complexity and distributed teams, the system engineer is playing an increasingly important role as the central contact person. From my point of view, the system engineer in medical technology has to deal with distributed teams and communication.

Special features in medical technology

A specialty in medical technology are the mostly small quantities. Here one can only dream of sales volumes like in the automotive or consumer electronics market. Of course, manufacturing costs are also an important factor in medical technology, but not as much as with price-driven products and products in very large quantities. If a product is sold several million times, then a few euros is already a lot. On the other hand, if you only sell a few thousand products, the costs are not that important.

The role of the systems engineer is not as widespread in medical technology as one might think. But that is changing increasingly. In the development team, individuals often take on several roles. A systems engineer (if this role was explicitly named) in medical technology is often a girl for everything and takes care of requirements, system architecture, project management and, most importantly, the control of the various disciplines (hardware, software, construction, system and test) . The job of a system engineer in medical technology is therefore very varied. “T-shaped skills” are necessary for this job! This concept is about combining broad knowledge and specialist knowledge (in-depth knowledge) in one person. The focus is on broad knowledge. The development engineers bring the specialist knowledge with them. However, if necessary, the systems engineer must also be able to go in-depth.

But as is likely in all industries, nothing beats experience in medical technology! The more experience you have in development as a systems engineer, the better for the project.

For everyone who is interested in the topic, I recommend the two blogs System Architects - why we need them and what they should be able to do? and introduce system architects in the company. In it I go into more detail about what system engineers should be able to do and how system engineers can be set up in a company. Because from my point of view, systems engineers are a rare species and difficult to find on the market. It therefore makes a lot more sense to build up system engineers in the company than to spend a long time looking for suitable people.

If you need help with this, please do not hesitate to contact me. I am happy to answer any questions you may have.

How are your experiences? I look forward to your feedback and the exchange with you. You are also welcome to leave a comment on the article. If you know someone for whom the blog could also be interesting, I would be very happy to receive a recommendation.

Best wishes
Goran Madzar

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