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I would imagine OP is referring to "Professional Engineer". https://www.nspe.org/resources/licensure/what-pe https://www.nspe.org/resources/licensure/what-pe

by fma 8y ago

I would imagine OP is referring to "Professional Engineer". https://www.nspe.org/resources/licensure/what-pe https://www.nspe.org/resources/licensure/what-pe Every single design, bridge, etc is certified by a Professional Engineer. Your ass is on the line. I don't mean just being fired from your job - but jail time. Per the website: "A century ago, anyone could work as an engineer without proof of competency. In order to protect the public health, safety, and welfare, the first engineering licensure law was enacted in 1907 in Wyoming. Now every state regulates the practice of engineering to ensure public safety by granting only Professional Engineers (PEs) the authority to sign and seal engineering plans and offer their services to the public. " I suspect, and hope, software used critically have the same. Yes it's more bureaucracy and overhead...but being in software, I know any joe schmoe can walk on and develop code without oversight. I'm not saying if you're making the next twitter, that you need a PE. Or that every developer needs to have a PE license - but like other industries there is one PE per X amount of non-PE engineers. Due to the Threac-25 incident (https://en.wikipedia.org/wiki/Therac-25 https://en.wikipedia.org/wiki/Therac-25) there are standards for medical software (https://en.wikipedia.org/wiki/IEC_62304 https://en.wikipedia.org/wiki/IEC_62304). I'm not in medical so I don't know how widely adopted, or how strict it is adhered to. But it might be IEC 62304 needs to be branched out.

ghaff 8y ago
PEs exist for many branches of engineering. Including software. But the PE for software engineers is apparently being discontinued due to lack of interest.
- pitaa 8y ago
  Yes, NCEES (the body that administers the Engineering licensing exams nationwide in the US) is discontinuing their Software Engineering exam next year because only ~80 people have taken it since it was created in 2013. I think the biggest problem they had was that despite having the exam, not many states actually issue Professional Engineer licenses in the Software Engineering discipline. Because of this, I don't see why anyone (in those states) would bother taking the exam if they can't actually get a license and use the title "Professional Engineer".
  - ghaff 8y ago
    I forgot licenses were by state. It's probably also the case that software engineers don't normally have to "sign off" on things for regulators in a formal way as is the case in other areas of engineering. So, other than having a title to stick on your business card, taking the PE exam doesn't buy you a whole lot whereas it's virtually required for other engineering branches.
bgribble 8y ago
In the US at least, the regulation of software in medical devices regulates the process by which the software is developed and tested. The qualifications of the people developing the code are somewhere down in the process-stack; there are no specific requirements [1]. In general, to follow "Current Good Manufacturing Practices" (a term of art in the FDA design controls regulation), qualifications for the people on the team have to be documented and a paper trail kept up-to-date, to be able to answer questions of the nature "was person <X> qualified to be working in this role? How do you know?" with objective evidence. It's up to the judgment of the engineering management of the project what they state the requirements of the role to be. If you say that it takes a high-school diploma or better to be able to develop life-safety-critical medical device software, you may pass a process audit since you document and track that requirement, but if there is an "adverse incident" I would think whoever signed off on that decision might be exposed to liability. [1] My specific knowledge about this is ~5 years out of date so this may have changed, but I doubt it
godelski 8y ago
> I would imagine OP is referring to "Professional Engineer". In part yes in part no. PE's will be held to a MUCH higher legal standard but every engineer is taught to hold themselves to a high ethical standard. That you are not supposed to do something dangerous even if you think you won't get in trouble for it. Even if it isn't directly your responsibility you are supposed to report something that looks dangerous. PE's do the final sign off and their ass is on the line much more than the engineers that actually did all the building and designing. But the code of ethics is supposed to be there all throughout the chain. So what I'm saying is that in software we are part of that chain. And therefore the ethical obligations should still hold. They should hold at every part of that chain. At no point in the process should anyone say "well it is someone else's ethical obligation or concern". If you touch something, if you see something, then it is part of your ethical obligation. At least as an engineer, but I would argue that it is also if you write software.

by fma 8y ago

ghaff 8y ago

PEs exist for many branches of engineering. Including software. But the PE for software engineers is apparently being discontinued due to lack of interest.

pitaa 8y ago
Yes, NCEES (the body that administers the Engineering licensing exams nationwide in the US) is discontinuing their Software Engineering exam next year because only ~80 people have taken it since it was created in 2013. I think the biggest problem they had was that despite having the exam, not many states actually issue Professional Engineer licenses in the Software Engineering discipline. Because of this, I don't see why anyone (in those states) would bother taking the exam if they can't actually get a license and use the title "Professional Engineer".
- ghaff 8y ago
  I forgot licenses were by state. It's probably also the case that software engineers don't normally have to "sign off" on things for regulators in a formal way as is the case in other areas of engineering. So, other than having a title to stick on your business card, taking the PE exam doesn't buy you a whole lot whereas it's virtually required for other engineering branches.

bgribble 8y ago

In the US at least, the regulation of software in medical devices regulates the process by which the software is developed and tested. The qualifications of the people developing the code are somewhere down in the process-stack; there are no specific requirements [1]. In general, to follow "Current Good Manufacturing Practices" (a term of art in the FDA design controls regulation), qualifications for the people on the team have to be documented and a paper trail kept up-to-date, to be able to answer questions of the nature "was person <X> qualified to be working in this role? How do you know?" with objective evidence. It's up to the judgment of the engineering management of the project what they state the requirements of the role to be. If you say that it takes a high-school diploma or better to be able to develop life-safety-critical medical device software, you may pass a process audit since you document and track that requirement, but if there is an "adverse incident" I would think whoever signed off on that decision might be exposed to liability. [1] My specific knowledge about this is ~5 years out of date so this may have changed, but I doubt it

godelski 8y ago

> I would imagine OP is referring to "Professional Engineer". In part yes in part no. PE's will be held to a MUCH higher legal standard but every engineer is taught to hold themselves to a high ethical standard. That you are not supposed to do something dangerous even if you think you won't get in trouble for it. Even if it isn't directly your responsibility you are supposed to report something that looks dangerous. PE's do the final sign off and their ass is on the line much more than the engineers that actually did all the building and designing. But the code of ethics is supposed to be there all throughout the chain. So what I'm saying is that in software we are part of that chain. And therefore the ethical obligations should still hold. They should hold at every part of that chain. At no point in the process should anyone say "well it is someone else's ethical obligation or concern". If you touch something, if you see something, then it is part of your ethical obligation. At least as an engineer, but I would argue that it is also if you write software.