ieve's Squall of Consciousness

Entry 12 - Professional Troublemaker

(Jan 26 2026)

A riddle

I am some kind of engineer in medical devices, but I don't...

Design the thing
Build the thing
Test the thing
Sell the thing
Market the thing
Implant the thing
Help with the doctors that implant the thing
Do the regulatory submissions / working with regulators to get the thing on market

What am I?

Troublemaker

It seems like I'm paid to find trouble. Maybe that's not the job description explicitly, but that's what I have been doing for years and continue doing and I haven't been fired, although I am counseled to "pick my battles" and "decide which hills you're going to die on."

This one goes to eleven

I had a pretty fucking bad time in my last relationship. It ended ~5 years ago now, so I've been free for a while, but the body holds the score.

(An aside, seems like The Body Holds the Score got a whole bonch of criticism for not being entirely scientifically valid. /r/bpdlovedones loves that book. It seems to be helpful for people who are actually suffering, even if it is maybe not accurate. Like my favorite professor told us at the beginning of smart materials class, "this isn't the reality of the physics of these materials, it's just phenomenological models that are useful for design")

Wait, this seems like it's coming in sideways, what does this have to do with being a troublegineer?

Well, after 14 years of gaslighting, having my points minimized and dismissed and needled to death by detailed dismantling, getting the ol DARVO (Deny, Attack, Reverse Victim and Offender), getting screamed at, triangulated at, and settling into a codependent traumabound turbo-minima where I just didn't see how I could leave and had no choice but to find a way to survive in the chaos, because there was always just enough 'wait I love you you're wonderful don't ever leave me' and 'i'll kill myself if you leave' to keep my brain fucked...

I'm a little bit sensitive to certain workplace behaviors, and feel like a lot of things are very personal when they maybe objectively might not be.

ieve is holding up protocol approvals

Immediate response - Uhm no I asked for specific justifications to be provided because it's unclear how the software tests as written meet the FDA criteria for things like stress testing under resource starvation or in a real environment where it needs to interact with other software products on the target hardware.

Oh and FDA says that normal case testing is the bare minimum but is typically insufficient to demonstrate system safety - these system tests being routed only appear to address normal case, despite the risks associated with these requirements shaking out as High Risk per the hazard analysis ... I can't verify that the protocols adequately address output forcing, robustness (unexpected or invalid inputs), or combinations of inputs.

They recommend to use certain systematic approaches to identify error cases to be tested. I'm _pretty sure_ these words are not just made up and are probably real software engineering techniques, although I don't have the ethos to say whether they absolutely are or are not required.

"No that's not needed. These are all either out of scope or are captured as requirements" ... I don't think that's right ... this guidance is describing _how_ the software should be tested, not _what things_ should be included. There is some overlap there where things might be bounds on certain inputs but this argument is predicated on the requirements being perfect, all encompassing, and having considered all possible inputs.

This is absolutely a handwaving argument but ... I don't have infinite energy and I definitely don't have infinite 'hill dying' currency to spend and so the best I can do is circulating meeting minutes "Management and product development have made {decision}, based on this strategy the burden for demonstrating compliance is pushed downstream to the verification master report, and individual protocols will not be reviewed for adequacy to the internal process or FDA guidance requirements for software scope."

The can has been kicked. Again. And I wasn't even fucking "holding off on approving", I asked for some pretty basic things to be justified so that I could verify scope complies with requirements and regulations. (Ugh, ok ieve, don't Justify Argue Defend or Explain. Treat them like closterbees, because even if they're not clinically closterbees, the overall pattern of behavior is the same and you know that's a problem for you.)

What even is the fucking point? Why am I here?

6 more cents

Two hours later, another meeting with boss-boss and regulatory boss. Usability validations have a bunch of deviations, which are normal for complicated tests - nothing ever goes perfectly to plan.

But the field personnel validation is a fucking disaster - skipped steps, missing screenshots as objective evidence, but at least there are attestations from the validation moderator that the expected result was met.

$0.02 - Attestations are not objective data that can be used to independently verify that the acceptance criteria was met. We have a cultural problem at {our company} where your team (talking to boss-boss of product development) is under the impression that clicking 'Pass' in a dropdown is usable as evidence and it exposes us to risk of data invalidation.
$0.02 - This data was never signed or archived. It's industry standard for a reason that we PDF-ify the data and sign/date for it at the time of execution. Contemporaneous is a real word, I didn't just make it up. How do I know that this attestation was even entered at the time of testing and you didn't just write it into this uncontrolled excel sheet two months after the testing was performed?
$0.02 - The sheer number of deviations here indicates a systemic error that should not be attributed solely to "Man" (human error). It's advisable to determine Method (process) root cause and implement a corrective action so that this doesn't happen in the future. This is exactly why datasheets have an independent data review signature field at the bottom (in a world where we actually signed our datasheets.)

Well, they didn't _entirely_ ignore or dismiss my points... It's like, maybe if I can just keep saying the words then eventually they'll catch on. But maybe it's like, being deep in a turbo-minima with just enough of a carrot dangling (Equity, Getting a full PMA submission all the way through FDA approval on my resume, People Being Decent Human Beings Most Of The Time, Freedom To Come And Go And Basically Work Whenever) that I don't see the path to going somewhere that actually does what are to me, _really fucking basic things_.

It costs a lot fucking more than $0.06. Everything is a fucking battle, and every battle costs _so fucking much_ time, spoons, social capital before, after, during. Maybe not for a normal person, an intact person, but for me, it costs a fucking lot.

Crushed

Saw the coworker I have... had? a crush on. Seemed like vibes were vibing for a while but then they suddenly didn't anymore. Maybe she realized I was catching feels and either did not want, or couldn't. I mean, I have to approve her work on this project (as a peer, not a manager) but still... it would complicate that if things went South, or maybe even if they went North.. And she's a Career Lady.

Anyway she's super nice and happy to chat if I initiate but it seems like things are very strictly scoped to Within The Walls Of The Office. That's ok.

Still ... she's so fucking cute. Even dressed down, in the lab, literally just a tee shirt and jeans and running shoes because she had no intention of going into the office-part-of-the-office that day ... damn ... she's so fucking pretty. Competent, in her element, smart, wonderful.

Anyway gave her my very last spoon for the day and it was _so worth it_. My other coworker down there was laughing at me "You're trying to do a triathlon in May and you're just now learning to swim?" Yes, yes I am.

Crush coworker completely earnestly told me she's really glad I'm starting with the absolute basics, learning to breathe and taking a beginners swim class. Thanks dude.

Anyway I'm pretty fucking sad about it. No blame, no expectations, nothing owed... just ... was pretty hopeful and really really like her, and now like, everything is really fucking hard and I really just need a hug, and I know the exact human I want the hug to come from, and know that is not going to happen.

- 🜌

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