• 2 Posts
  • 42 Comments
Joined 2 years ago
cake
Cake day: June 20th, 2023

help-circle


  • This depends on the area of medical device. I work in medical device but totally different from this, mine get implanted into your body.

    1. I doubt many people have the knowledge to to truly troubleshoot our devices beyond what the doctor is allowed to do. We need a bunch of expensive and specialized hardware to troubleshoot.

    2. We are legally required to investigate and report any complaints(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) . If we don’t get the complaint we can’t investigate and report it.

    3. If a certain number(honestly I don’t know the specific number) of complaints occur we are legally required to create a corrective action to help the patients immediately (or as soon as possible) and a preventive action to ensure it doesn’t effect other patients. If a person has an issue and “repaired” it themselves they don’t get counted in this and as such could cause more patients to suffer.

    While I agree with right to repair I think certain things should be exempt. That said then there should be a requirement of the manufacturer to ivestigate/repair the equipment.



  • I do this alot but I alway follow up with “Do you know what blah is?” and depending on age/experience/acronym or term I ask them to explain it.

    Sometimes I get assigned work with a senior engineer(where I learn) and sometimes I get asked to help a new person. For example right now I’m in a project being driven by a senior engineer but was asked to assist a professional development program employee(or pdp) to actually execute the project. As a result this is the habit I developed to 1. Make sure I don’t confuse people with random acronyms or terms 2. Ensure we are on the same regarding definition(and they are not just saying yes I know when they don’t).




  • I’m also a software engineer (at least in title). I agree with the social skills but a different thing came to mind. The ability to actually watch and understand what people are trying to do. I’m lucky as all my software is internal to my company. I don’t make what we sell, I make what tests the products we sell. And yes I test the tests and also test the test’s tests 😭.

    I’ll give an example. I have an operation where the operator is to scan a number off a paper before testing. That number is for traceability we need to know which test results are for which unit. Previous engineer said since it’s scanned off the unit it will never be incorrect as long on the printed barcode is correct(separately validated) so no need to verify format.

    I ran into an issue where units had an extra zero either before or after the number. So if number was 12345 sometimes it would be 012345 or 123450.

    I went to watch the process. The operator scanned the unit( I watched them work all day, this was 1 unit out of a whole days work) and when they put the scanner down the scanner’s corner was on the 0 button of the keypad.

    We did a 2 phase remiduation. Stage 1. Operator instructed to log in and then place keyboard on shelf away from workplace. Stage 2. Verify the number is in correct format in code. Yes the code update is simple but in our field needs weeks of work to test, validate, and release.

    Actually watching the operator closely identified the problem. The code was not the issue, the code passed all requirements and tests. The issue was the tests and requirements did not match the user’s experience but if I stayed in my cube as for weeks I would not of been able to find the bug.









  • I work for a medical device manufacturer and you are missing a important reason for that exception. Yes human lives are on the line. In addition WE (meaning my company) are responsible for finding out why it broke and how we will prevent other devices we make from breaking.

    We make a device and say it will last 10 years, 2 years later it stops. We have to replace it, We have to investigate to the best of our ability, We have to report our findings to the government, if several cases happen We need to come up with a prevention for the future dailures(or prevention if severe enough). We have entire departments for this. It is our burden not the consumer and it’s our burden so we have enough evidence to determine root cause and final solution so we can prevent further failures.


  • I’ve done some gcode but moved onto other programming(mostly c# so completely different. One thing I HATED about gcode, I don’t know if it was just my machines or gcode in general(most of mine were based on fanuc cnc controllers typically seen as top of the line) , we were not able to name variables.

    I create a variable and assign it #315. What does #315 do? What does it mean? Who knows… Better have notes or comments to explain or your fucked. I can’t say variable x_offset_tool_15 nope…just #315.