Summary: A winding rant about finding value as as a med device QE, getting along with difficult personalities and risk tolerances that don't mesh well with mine, and wondering why I'm doing any of this at all...
My boss is abrasive and I've reached the point where I'm just enduring.
I would like to say that work in general is fine and it's just this particular person that sometimes bristles my fur... but I think I'm having a whole existential crisis about being a medical device QE (Quality Engineer).
The previous company I was at (BigCo) really valued Quality - that is to say, they always made the 'right' / safe decisions (we would scrap a ton of product that was probably okay, but had a remote chance of causing patient harm), and they saw value in things like Good Documentation Practices (GDP) and data integrity, and in having clear, well written justifications and explanations for how things work.
At BigCo, especially in focus factory / production support, the value proposition of a QE was clear: Keep the line running without a recall.
Stuff just happens - materials come in with defects, machines get settings changed or fixtures misaligned, operators miss things. Product gets flagged and we need to decide... stop the line or keep going? Does this lot need quarantine? Can the machine continue to run like this? Should this operator continue to work on this process? It takes constant vigilance and effort to keep the production line from unraveling under its own entropy... and when the line puts out $200-300k of saleable product per day, there's a ton of pressure from Operations / Supply Chain teams to get things back online fast, weighed against the risk of recall if defectives escape. It's not a great feeling in the moment to get a call from supply chain asking when we're going to release their lot of a certain SKU of product because they're trying to avert backorder - but there a meaningful energy and urgency from having such a direct and obvious impact on the business.
I didn't get to experience product development / R&D / NPI (New Product Introduction) at BigCo, so I'm having to compare Big Apples to Small Oranges here... but... at this smaller late-stage startup / early-stage commercialization ramp company, it's pretty clear that Quality is a cost of doing business.
To me, quality systems are like project management / systems engineering tools -- you might need to tailor it to your needs, but really using the systems brings incredible benefits compared to 'winging it'. You get out what you put in. I learned most of my systems engineering / project skills from Space Systems Engineering - Home, my FSAE (race car team) advisor in school, and from applying it to FSAE. So... although I'm not very experienced in the design/development side of medical devices, I have a whole bunch of techniques / ideas in my back pocket that are proven to work in complex system designs / projects.
However, in a self-fulfilling prophecy, it turns out that if you just 'check the box' of Quality & Design Controls processes, and 'wing it' on project/program management, these systems don't yield much value.
The work is often technically sufficient to fulfill its requirement and check the box, but not usable for, and not really intended to be used for, actual engineering work. If we intended to use an initial risk analysis to inform the design, it would have been 1+ years ago when the design was in a nascent state.
In all fairness, the systems guy does care about risks, does care about & has done a lot of work to mitigate patient safety and company risks... and it's not like the rest of the R&D team don't care. They're just... cowboys. In their minds, I guess, they're trying to cut through red tape and come up with solutions that technically meet the requirements with minimum effort, because that's what needs to be done to get to market.
But I'm a systems guy - I'm a believer. Not every problem will be solved with a 6M and a contradiction matrix but you'll solve a lot more problems with the tools than without. Eschewing a detailed project schedule 'because Gantt charts go stale as soon as they're created' is absurd - the value isn't (only) in the dates, but also in the mapping out the project with dependencies and putting some thought into what the work items are for each deliverable.
But hey - what do I know ...
It kind of sucks to sit in All Hands Meetings where sales and clinical access teams are not just the stars of the show, but... the whole show.
I understand that they are the profit centers, and having product flowing / inventory on the shelves doesn't matter if you don't have a therapy that Payers will actually pay for. Sure there is the blanket everybody in the company contributes to this success statement from our CEO, but, damn if it doesn't feel like a vacuum of leadership "in our corner of the ring."
I feel like I'm not asking for a lot. I just want some recognition and understanding that just like a production line will crumble under its own weight without a team to maintain it, the business doesn't run itself. It is absolutely not trivial to keep a 15 year old product line on the shelves - there are constant upstream material changes, components going out of stock, equipment breaking down, defective product received. All of these updates and issues need to be coordinated with our CM (Contract Manufacturers), and essential information to support the changes (for our obligations as legal manufacturer to assess changes and verify/validate prior to implementation) needs to be extracted from behind the iron curtain that is our CM's "proprietary information" policy.
It's absolutely not trivial to keep inventory flowing through receipt & distribution. It takes people grinding out received product and returned product inspections all day to ensure the product in the hands of our Profit Center is pretty close to perfect every time, and that we investigate root cause any time it's not perfect. Takes a whole team of warehouse guys to manage traceability of exactly which serial of product went where, so we can track it down to the patient level if needed for a recall.
There are a dozen more roles like this behind the scenes. Does finance ever get a callout, let alone a bonus for doing a great job passing their audit, and keeping paychecks flowing into everyone's bank account? No - it's invisible work that is only apparent when something goes wrong. (And there often isn't room in these sustaining roles to go 'find something' to get recognized for.)
Do I expect the CEO to call each of these groups out when celebrating a big company win? No... but our direct leaders don't really celebrate us either. I understand that from the executive point of view maybe you don't want to claim any 'wins' because the business has been looking to the technical team to deliver on their promises and we're behind on delivering... but... some of the technical team (honestly not me) are turbo grinding to try to meet the promises that were made. Sure we got a recognition lunch for that project-within-project team, which was nice...
But like, would it have killed our area leader to acknowledge the team pushing incredibly hard, when they were already giving an update to the entire company about the state of our systems update project?
The Herculean, often Sisyphean efforts that the team puts in every day - the late nights, the performance regressions and unexpected bugs throwing expected timelines, endless hours spent poring over standards and guidances and technical documentation, spicy uncomfortable conversations pushing our CMs harder... in our executive business leader's mind, these were all overshadowed by (what I perceive to be) his insecurity about whether we'll deliver on time (on a nontrivial but arbitrary milestone / date) and therefore not taking / giving any credit. Maybe appropriate for executive level meetings, but in an all-hands type environment ... like there is power in a little bit of positive vibes, and I wish they would have taken the opportunity.
I don't know, man. I had a boss, many moons ago at Pizza Shop, who every single day after reconciling your cash at end of your shift would say "Thanks for your help today". It was such a simple, small thing.. but also a reminder of the humanity and effort on both sides.
I think there's a severe disconnect between what our company leaders see/discuss, and what is really happening behind the scenes. Like getting a professional development goal that includes 'collaboration with other groups to come to creative solutions expeditiously to move things forward'.
Okay. What do you think we've been doing for the last few years? Every single thing that comes through (close to it, at least) needs massaging / updates to get it into the "80% of the way there is good enough" zone. That's all I do is work with people to figure out how to "magnetically align" their work enough to let it go through.
When it is clearly in the "good enough" zone, a review often takes only minutes. (Look for whether certain things are there, boom boom boom yup looks good click the approve button).
Or is the point of the goal to figure out how to do it with less friction? More expeditiously? My initial reaction is defensive because it seems to completely ignore the dynamic that's been going on. And I'm extra confused because we've been talking as a team over the last ~2 years about how our team makes up for inadequate work across the business, putting in extra effort ourselves to find a path forward. So surely the person who assigned this goal knows I already do that right?
It makes me realize that the impression management / business leaders have of you is not typically based in reality. Or at least not my reality. They might remember one comment or one interaction and that memory where I did something "wrong", or I was "difficult", or I "needed to tone it down" that totally overshadows a hundred other instances where I was measured and helpful and found a path forward that met all needs.
So clearly there are layers to this stinky ogre - the culture shock of realizing this company considers Quality as a 'necessary evil cost center' is only a part. These feelings are all jumbled together, but today's reflection post is brought to you in particular by the author's abrasive manager.
They're not outright spicy, or consistently unprofessional... there's enough of a veneer of professionalism, and friendly-ish interaction most of the time. I realize that by being completely overwhelmed, things are spilling and I'm not entirely reliable - we discuss that we should probably do {something}, but I can never get around to it because my primary responsibilities always take priority. The unreliable part, I guess, is letting myself just go into a black hole while I focus on (what seems like) the obvious most important thing, and delegating or escalating enough / early enough when things start to slip.
That is a fair criticism.
What I feel like I'm enduring, on the other hand, are offhand comments during staff meetings and 1:1's that are pretty targeted and tear me down a notch. I'm not sure if the intent is to take me down a notch? Like "What can you delegate to the team? I'm trying to help you, I don't need to be getting phone calls" and bringing up in staff that she has a "list of stuff sitting with you." Who gave her the list? What's on the list? Is it actually relevant to my immediate priorities for the next week? (which are very narrowly scoped and clear) ... /shrug
The "list of stuff sitting with me" is probably related to being burnt out after two years of chaos, plus leadership actively shutting down any attempt at organized project / program management, plus just a fundamental mismatch in the amount of time they expect to allocate to a complicated technical review. To do a real review of product requirements / risk documents for a complete system overhaul (thousands of requirements, a dozen risk analyses, dozens of usability flows and features, connectivity and cybersecurity and key management...), even at the inputs/requirements phase, could easily take weeks. Sure I was around when the team was developing those requirements, but I was working on other projects / doing run the business stuff, and I've pawed through them, but it's really not the same thing as allocating dedicated time to working that deliverable.
Sure I suck at delegating. Not that there's a lot of team to delegate to? Everyone already has more than a full load of responsibilities. And I really can't delegate the work of spending many many hours swimming up and down the requirements and risk docs and design docs incorporating everything into my brain so that I can reason about the system.
And the fact that there is a "list of stuff sitting with me" that I don't know about signals a problem with the communication at this company. It's not a direct "hey when will this be done, what's blocking you, how could we {authors of the deliverables} help make it easy / quick to review?" -- it's someone going to my boss complaining that it's taking too long to get to their thing, or I'm being too picky, or.. who even knows what.
And that's just this week. It's like, every single week boss does something disruptive and expensive in terms of emotional energy... Attempting to explain why a certain statistical analysis I did was 'wrong and a bad choice', and explaining an 'actually wrong' understanding of how the analysis works to the team. Cutting me off explaining something to say I'm wrong and saying... exactly the same thing I was saying. Cursing and being visibly angry / irritated, "We're not fucking doing that", in response to a path I proposed.
Taken individually I try to give my coworkers grace when they're a little spicy - we're all under a lot of pressure. But this isn't spicy, this is pretty targeted. Nobody else gets roasted every staff meeting. Are you trying to publicly humiliate me / tear me down? Or do you just not know? Chock it up to "being direct"?
And then the next day pretending as if nothing happened. And to them, perhaps nothing happened - the type of person who is so careless with their emotions that they don't even understand that they are hurting people. Or worse, the type of person who is physically/mentally incapable of taking responsibility for their own emotions - they'll burn the whole goddamn world before they acknowledge that they may be the problem.
The 'friendliness' feels so slimy now, in a push-pull pattern and with the refusal to possibly be wrong - it's unfortunately familiar.
Ugh, I had so much work I needed to get done today and all I did instead was ruminate and write this. It's already 4pm...
I don't know how to set all of this aside so that I can focus. Like what even is the fucking point ? The development team is going to do whatever they want regardless of my review, and when it comes for approval my boss will tell me to "figure out a creative solution to move it forward." Despite being a NPI design controls project, the product is essentially already designed and starting preproduction runs by the time they're doing the 'on paper' development. There are new systems that are needed, but my "lane" is product and not quality systems and if I even peek outside of my lane, I'll get an aggressive message from my boss. "I hope you're not in {shared copy of software development procedure draft} right now."
At BigCo, even if the commercial organization doesn't understand, at least within the engineering group there's a pretty high bar for quality of work / analysis / documentation.
Here... leadership is mostly interested in (1) will anyone die and (2) will we get shut down. No? Send it.
And that leaves me not really understanding... what even is the fucking point of trying so hard? Why am I fighting for the basics of objective evidence and GDP and like, signing for your work...
If nobody else cares, why can't I convince myself not to care, so that I can just have an easy job where I skim and check a few boxes and let it go? It's not like I'm the one who will go to jail if someone dies - that's on my boss.
I had this analogy in my head that our business is 'weaving a tapestry', and my job is to find threads that are out of place and tuck them back in, trending asymptotically to some cohesive whole that is easy to defend to regulators, & easy to maintain and understand for our team. (Lessons won from having to maintain, understand and defend product/process designs that were 'pitched over the fence' long ago. *Presumably* some of the knowledge they hired me for?)
But uh. I think my job might actually be to shut up and find a way to sign it.
Disclaimer: Post written in frustration, doesn't reflect opinions of my employer, coworkers, teammates. I don't suspect product quality or patient safety to be in jeopardy, and would put a stop to it if I did suspect. (I probably have the most conservative risk tolerance around here though...) I'm still going to try to not fuck over future engineers by 'pitching crap over the fence' because I do support the therapy. (Also I want the options to become stonks...) Just wish they weren't so fucking difficult to work with.