S7E7 Mike Romance | Industry 4.0, Production Transfers, & People-Centric Leadership

Mike Romance has spent nearly two decades operating at the intersection of manufacturing engineering, automation, validation, and operations leadership within the life-sciences ecosystem. His career spans startups and established organizations alike, with hands-on experience taking products from early development through GMP-ready, high-volume production. Across roles in process development, automation, quality systems, and manufacturing strategy, Mike has built a reputation for combining technical rigor with pragmatic execution.

Most recently at Quantum-Si, Mike played a central role in scaling operations to support the commercialization of the Platinum protein sequencing platform while laying the groundwork for next-generation technologies like the Proteus platform. Working within a lean and highly agile leadership team, he helped establish scalable manufacturing foundations spanning CM-managed instrument supply, internal reagent kit production, and advanced silicon-based consumables—while navigating the realities of fast-moving product roadmaps and constrained resources.

Earlier in his career, Mike held engineering and leadership roles at organizations including Illumina, Dexcom, GenMark Diagnostics, Truvian, and Encodia. Along the way, he’s led pilot-line development, automation strategy, equipment qualification, validation programs, and process controls—often in environments where the path forward wasn’t clearly defined.

What sets Mike apart is not just his command of acronyms—GAMP, CQV, QbD, DFSS, FMEA—but his philosophy that systems only work when people do. He actively practices emotionally intelligent leadership, prioritizing trust, clarity, and psychological safety while still holding teams to high technical and operational standards. As Mike explores his next chapter, this conversation focuses on the lessons he’s learned building resilient manufacturing systems—and the kind of organizations where he believes he can make the biggest impact next.

LINKS:

Guest LinkedIn: https://www.linkedin.com/in/mikeromance/

Aaron Moncur, host

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Transcript

Mike Romance: 0:00

For me, I want to be a thought leader and a people leader. That's, that's my goal. So I think anywhere I can, you know, whether it be aerospace or life sciences, anywhere I can contribute there and have just a team that really wants to, like, like, push the boundaries of collaboration. That's, that's huge for me right now. I want to learn from people, kind of in that phase in my life right now. So let let some smart people do the work.

Aaron Moncur: 0:35

Hello and welcome to the being an engineer podcast. Today's guest is Mike romance, an operations engineering and quality leader with deep experience scaling Life Science manufacturing from early commercialization through high volume production, most recently at Quantum psi, Mike helped architect and scale operations supporting both instrument supply chains and complex consumables manufacturing, including silicone chip based flow sales and reagent kits. He is passionate about lab and factory automation, digital transformation and industry 4.0 and just as importantly, about building high trust teams through emotional intelligence and conscious leadership. Mike is currently open to new opportunities, and today's conversation is all about sharing hard earned lessons from the front lines of modern manufacturing. Mike, thank you so much for being on the show today.

Mike Romance: 1:36

Yeah, hey, thanks for having me. Aaron, super, super excited for this saw a couple of questions. They're definitely peaking interest. I can't wait to get into it.

Aaron Moncur: 1:45

Awesome. So in this episode, we're going to do something new. We haven't done this before. We're going to do some rapid fire questions. I haven't told Mike what these questions are yet, so there'll be a surprise to him as well. And the intent here is to give the audience a chance to get to know our guests a little bit very quickly. So we're going to try this out, see how it goes. Just a handful of these rapid fire questions. Mike, we're not looking for deep responses here. Don't put too much thought into it, just gut reaction, whatever, whatever comes out. We've got three or four of these, and then then we'll move on to the standard questions for the interview. So here we go, first and foremost, what engineering breakthrough Do you think had the biggest impact on modern life?

Mike Romance: 2:30

Modern life, I gotta say these. I don't know if I call it engineering, but these, AI's, chat, GBT, models are absolutely incredible. I I've been playing with them. My son's been playing with them. I It's almost like when Google and search engines came out, but another level. So I don't want to be like an AI fanboy, but, uh, but I'm, I'm impressed, and I gotta, I gotta keep my skills up too. You know, I

Aaron Moncur: 2:54

don't think anyone's gonna argue with that answer, yeah, okay, next one, build from scratch or improve an existing system.

Mike Romance: 3:02

Oh, man, depends how much you know about that system, right? So if it's, uh, if it's mature, um, documented, understood their support, you know, it depends how, how rugged it is. But, you know, I like new things. I work in medical so everything's, you know, stainless and shiny, at least, that's the desire. So I would go that way. But I think it's a circumstance, circumstantial thing. I think if it's, if it's working, and it's, you know, especially if it's novel, you might have to leave it alone until you figure it out.

Aaron Moncur: 3:33

And we see that deep thought process coming through here. All right, next one proven methods or experimental approaches.

Mike Romance: 3:41

Oh, man, hybrid is good. You know, I like to, I would normally go proven methods, because I'm an engineer, right? But I think you got to lean into the fact that, um, you know, people want to come up with new ideas, try new things. I think there's a value in learning things, trying, pushing the boundaries, learning when they don't work to I think that's always very good. So, yeah, again, circumstantial, I

Aaron Moncur: 4:02

think, all right, last one, if failure were impossible, what would you attempt?

Mike Romance: 4:15

Way to stump me? Everything. I don't know that's everything

Aaron Moncur: 4:23

I had this. It was a slightly different form of the question, but an engineer once told me, if there was any tool that he could invent that would aid in in successful engineering, it would be shoot. Now I'm forgetting the word. What's it called on Star Trek, where a person suddenly appears in another place, teleportation, I think, right, yeah, that'd be pretty amazing. Wouldn't that be sweet?

Mike Romance: 4:47

Well, you didn't say, in engineering, you said, if you, if you know, failure was, my mind's going different, always, all sorts of things humanity, you know, at this point, given back is probably, you know, teleportation, maybe. Can use that for good as well. You never, I'm sure you can.

Aaron Moncur: 5:02

I'm sure, yeah, okay, cool. Well, let's, let's jump into what I'll call these standard questions now. So the one that I always start with is, what made you decide to become an engineer?

Mike Romance: 5:16

Decide is the key word. I think my natural evolution since I've been a kid, is, I love tinkering with stuff. I love building stuff. I always used to repair broken things just for fun, right? And everyone said, Hey, you're gonna be an engineer. So I don't know if I got to this side. I think kind of the world and the universe kind of, you know, chose me to kind of fall on this path. I had a lot of interest, a ton of them, but that's kind of where, you know, parents and friends, just everyone kind of knew it. And the funny thing is, my six year old right now, I'm seeing it in him. He's he's kind of repeating some of that. My other my other son, my 10 year old, you know, totally different. It's fun to watch him go. But now I'm starting to see these familiar things that when I was a child, I I used to do. So who knows? I mean,

Aaron Moncur: 5:58

that's fine. I might be the next engineer. What are some of these things that you're observing in your son, actually,

Mike Romance: 6:04

so it's interesting. Like, cooking right now is interesting, but, like, very meticulous on dicing and slicing and pulling out the craft box and making paper planes. I mean, some of that stuff's so like, you know, Legos and cars and launching stuff, and some of that stuff is so typical for a kid, but, you know, you start to see this, and it brings me back to when you were young, and you start to see some of the tendencies. So he is, I think everyone in my family would say they're starting to see some of that come out of them. So we'll see where he goes. You know,

Aaron Moncur: 6:33

I remember when I was a kid, paper airplanes were a big thing for me. I loved them, and I had an uncle. I was pretty little at this point in my defense. But I had an uncle who was, I guess, good at making paper airplanes. And I, for years, I didn't, I could never remember his name. We didn't see him very often, but he was just the guy that knows how to make really good paper airplanes.

Mike Romance: 6:54

That's how I refer to the best, right, right? Yeah, all right.

Aaron Moncur: 6:58

So you've worked across both startups and and some larger organizations as well. And your your expertise, at least part of your expertise lies in operations and manufacturing. How do you know when, when you're looking at a company and their operations, if, if they're developing for for scale, versus just, you know, let's just get something out there and make sure it works well enough.

Mike Romance: 7:25

I think he termed that as survival, right? And I was waiting for that, yeah? Well, I think, I think it depends. I mean, I have to for the audience here, right? Like my life, my my career, has been in life sciences, which is, you know, for the most part, early on, it's based off funding, right? And you're trying to create a product that, you know, maybe there's some market for, but they're, you know, you're really trying to, you know, in some ways, invent the market, or find a find some growth that kind of can give you that inflection point. So, you know, just, I think I'm used to now some of the bigger companies, I think they had more established processes, more established equipment, but I think I'm used to now kind of walking in and seeing processes that might have come quickly out of development that needed an operations team to just keep moving them along. So I'm comfortable with that. But like I said before, and kind of alluded to, I think there's some good Operations Engineering, if you want to call it, that, manufacturing engineering, due diligence, that really kind of lets you know whether or not the company has invested in the setting up the framework, or even the scale with intent versus, you know, just kind of reactionary, right? We'll talk proactive versus reactive quite often. And I think, you know some of that quality stuff, when you look at lean and all that, you'll you'll hear people talk about how expensive it is to do react, reactive stuff after value has been built into the product. So I think I missed that. I think that's a mature industry mindset, and, you know, I'm trying to actually bring that to the table, especially the earlier am, just to help people understand it. But sometimes you just have to live it, right? Yeah, learn it that way.

Aaron Moncur: 9:03

Now, you and I, we've we've known each other for, I don't know, it's been maybe a year and a half, something like that take longer, year or two, maybe a couple years now. So we've had conversations outside of this podcast. This is not our first conversation, and one of the topics that we have discussed here and there is automation and scaling processes and for a startup, of course, like, you know, getting into automation too early just doesn't make sense, because you're still working with kind of, I don't know if I call them immature processes, but you just don't, you don't have the skill to warrant something like that. How do you look at processes like you mentioned, that may have come from developmental roots, and decide when or if it's they're ready to, like, take it to the next step. All right, let's start scaling this process up and making it a little bit more robust and reliable. Yeah.

Mike Romance: 9:55

So the the inflection point I see is, you know, there's two reasons to automate, right? There's going to be either. Or, you know, it's meticulous process that, you know, maybe human hands can't do consistently. So I'd say maybe a quality approach there. And sometimes, you know, if you do it right, the the equipment is repeatable. That's why you jump into equipment and automation. And it's gotten so much better, right? Used to be like, you know, three axis gantries and stuff like that. And now robots kind of can jump in. Kind of can jump in. So it's either, it's either based off of a quality need, which I see less of that. But you know, then it gets down to a labor, labor need, do you, you know, are you paying people to do something, especially if it's ergonomically, you know, a sensitive slash, you know, risky, in some cases, to do something that you're going to constantly have to change out the personnel, cross train, etc. So there's advantages there. I think it like everything. It depends on the situation you're in. But for early startups, usually it's, it's, you know, use your people, use the people who maybe did it in dev and did it in pilot stage, until you can justify said labor savings and or, you know, the quality needs. So I think it shows itself fairly well. But what I will caution, and you know this because you're in this, you know, this is what you do. But automation projects are not trivial, and they do take time, and they do cost money. And, you know, discussing requirements with a integrator like you, or you know, anybody else, is an activity. Even if you're right the best URS, there's just constant negotiation. So I think that gets overlooked quite often, and might lead people to stay into the manual sometimes too long, versus maybe they need to start or staff earlier. And I think that's where I've been trying to help bridge a gap that I've seen.

Aaron Moncur: 11:38

Yeah, and it's not a trivial decision. It's not easy, necessarily, to understand when that inflection point arrives. I remember reading Elon Musk's biography, and he talked about automating at Tesla, and how they just automated everything right off the bat, right off the bat, and then he regretted it, you know, like there were definitely processes that just didn't make sense to automate, whether it was at that point or just period, right? Because, like you said, human hands, they're the dexterity. We still don't quite have that with robots, and there are just some processes that are better suited to human hands taking care of them.

Mike Romance: 12:13

Yeah, I, I think, you know, I always go back to this has been done this way for so long, and without automation. And in a lot of a lot of cases, you know, I mean, my passion project is actually love. Like, when I was a young engineer, it was there was less automation. There was still it was humans, even if we're loading like a thermal former, for example, in one of my past lives, like, I love getting on the line and learning the people on the line, and you know their history and their needs, and, you know, they're making making product for you. It's actually fantastic. And you know what, if you, if you do it right, they have these secrets to, kind of all the problems that you're going to have when you automate right. But then you kind of have to have that parallel exercise and start early enough for you to, you know, start these projects and complete them on time and successfully. Like you can't just decide one day to automate it, just it doesn't work that way. Yeah. So I'd actually rather see people on the floor, to be honest, as long as you can take it, but you should have kind of these parallel trigger points that would kind of kick it off,

Aaron Moncur: 13:10

you know, amen, I think that's wise. Let's talk about industry 4.0 for a little bit. First of all, what is your definition? How do you think about industry 4.0

Mike Romance: 13:21

Yeah, I don't know if you saw on my LinkedIn, I call it industry X point. Oh, because there's just been so many different iterations of this. Now I hear people saying 5.0

Aaron Moncur: 13:32

and x point. Oh, then how do you think of industry X point?

Mike Romance: 13:34

Oh, God, no, someone's gonna call me on this. Well, I mean, you know, I haven't memorized all the phases, but you know, there's industrial revolution and people and, you know, you're iterating, and then, you know, machines. I think we get to the point to where, at least with industry 4.0 to where you're trying to mechanize things as much as possible. But I think it's more about data at that point, predictive maintenance, you know, but even more so than that, again, in my industry, a lot of this is novel stuff we're doing. And some of the equipment, if we're using bioreactors or cell culture and all that stuff, they might not be, you know, like a heat staking operation, where you get your, you know your your control parameters already coming out, and you know what you're gonna monitor, and you kind of have an understanding of the materials, right? Some of this stuff is, we're still learning about it, and especially it's novel for the application. So when I say 4.0 I think it's being it's going back to that proactive, you know, trying to know the data you need, the data you want. Some of its operational, some of its process oriented, some of it's quality oriented. Some of it's, you know, dollars and cents, but trying to know that up front and architect your system so that stuff is available to help you make decisions faster. That's what I would say. 4.0 is I'm seeing a lot of this kind of actually moving to hey, you know, you don't need dashboards. You don't need KPIs. Just throw, put every data you have, throw it into AI and just ask it how your operation is doing. You. And I think, just like anything else, and this might be controversial, but I think that if you start to teach people to do that, you kind of miss out on the fundamentals about OE and, you know, just in time and all that stuff. And I'm not trying to throw buzzwords, but, like, I spent my whole career learning this stuff, right? Yes, AI can help me, but it doesn't really teach you the pain points that I think people have learned over the past year. So 4.0 for me is making data available to make decisions faster and better. But you need to know what decisions you need to make and what data you have and you need to collect and mine and look at to make those decisions, at least that's where my head goes. What do you think? Aaron? What is

Aaron Moncur: 15:39

4.0 to you. I like the word that you use, predictive. I think that sums it up very well. It's predictive, right? You have all this data, and data, for data's sake, doesn't mean anything that you need to have something to do with that data. And that's what we're trying to do. We're trying to predict. You know, when is this machine going to go down? When is this machine going to need maintenance? You might, I mean, frankly, we we deliver custom manufacturing equipment, right? But, and we always deliver, like a maintenance schedule with it. But do we really know exactly what that maintenance schedule is supposed to be? No, we. I mean, we have history that we can look at, and we have data sheets from our component suppliers and things like that that we can use and we do, but at the end of the day, this is like a brand new machine that has never existed before, and so acquiring data from that machine over time and then using it to predict maybe we give you a manual that says this maintenance needs to be done every three months, and maybe it takes a day, so your that machine is shut down for a Day. That's that's a loss for that company, but maybe over time you collect data and you learn that actually, we can go five months before we need to do any any maintenance on that. So that's how I think about industry 4.0 Are there any kind of foundational elements when you think about industry 4.0 that you think gets skipped sometimes and maybe have a big and not necessarily good impact later on. Pipeline now offers procurement of custom machined parts at significantly lower costs without sacrificing speed or quality. We design and build custom machines ourselves, so we consume a lot of precision machined components. Over the past several years, we developed a proven overseas supply chain to support that work, and in 2025 we successfully piloted that capability with select customers. Now we're opening it up more broadly. If you'd like to see how our prices and lead times compare, send us a drawing or two for quote, visit team pipeline.us, or message me directly on LinkedIn.

Mike Romance: 18:40

Well, I mean, let's just kind of move off of what you were just talking about with maintenance, because that's an easy one to go after, right? Like, you know, you got to remember, we're talking about early life in a company. Sometimes it's a brand new company with a brand new team, right? And, you know, it's, it's, you tend to not get the very veteran, you know, big guys, big gals, you know, as far as your, you know, operations heads and stuff, because it's you need, you need a different type of skill set in some cases, right? So to even have a discussion about maintenance in general can be challenging. And I'm just telling you this straight up from, you know, my past three years, I'm literally having these discussions, right? Do we really have to do maintenance at this point? Right? At least you're doing maintenance. Actually had a discussion with an engineer who I've been taken under my wing and trying to teach him stuff. And he's like, do we have two minutes? Nothing's wrong with it. The band seals look fantastic, right? And I'm like, if it's called proactive maintenance, it's a planned maintenance, it's not reactive maintenance. So there's still, at least in my industry, we still, we still struggle with staffing for that. Think about, think about that, right? So I appreciate you guys even sending a recommended maintenance schedule. And that may sound super, you know, absolute hard requirement for most people, but you know, you got to remember. And again, I'm going to go back to my situation, right? Life Sciences is about a generation of ideas, and, you know, science and not necessarily operations. You need to have a product that has demand. You need to have sales in order for it to turn into that so early on, you are fighting an uphill battle, because most of the discussions want to be around the technology and the development of the product, less around, I need people to staff and do maintenance on a band sealer every three or six months or sooner, if you know, right? So to your point, when you go back to this full circle on 4.0 you know, you guys and several other vendors, I'm sure, but you guys are going to, you know, maybe try to implement some, you know, predictive maintenance analysis, or sensors that might be used to help detect vibration, right? I'm just. Throwing all this stuff out there. And that's fantastic, right? Because I think sometimes that will ease up on us putting an arbitrary three months to a PM, that might actually be a year before you see a performance degradation. So really cool. We're talking about this. But that's one vendor, one process, one tool. I think if you look at it, the landscape like, you know, it's kind of an adoption. I think of all the vendors to get to that point, otherwise, you're gonna have a mixed bag of, you know, planned maintenance and predictive maintenance. So I think it's a big lift all around

Aaron Moncur: 21:12

yeah, let's take a step back here and talk about life sciences in general. Because there might be, I bet there are a lot of people listening to this right now who hear the term life sciences and like, oh, yeah, I kind of know kind of what that is, but like, maybe not to, well, definitely not to the level of detail that you do help us understand, what are life sciences? What are we talking about there?

Mike Romance: 21:36

I've seen the term evolve, right biotech, which is interesting because it's being applied a lot to pharma and Biotherapeutics right now and again, if you're any familiar with kind of this space, the life sciences, or biotech space, like biotech, like, you know, biological technology, you know, it's, it's interesting. Could mean anything, right? But if you dig deep, there's, you know, medical devices, a lot of times governed by, well, for the most part, governed by the FDA, the GMPs and all that, the regs, pharma also regs, right? And there's kind of some of this early science where they're trying to figure out some novel protein, or even technology, like, where I just came from, that isn't regulated, because we're not trying to diagnose disease yet, right? So I think there's a bunch of categories in life sciences, but I think at the end of the day, as opposed to aerospace or commercial applications, life sciences are the science and the tools and the you know, stuff for the for our lives, all for our lives. But in our case, it's medical a lot of ways, or at least some sort of, you know, medical application.

Aaron Moncur: 22:44

Yeah, can you talk just a little bit about how did you get into life sciences originally? Like, was that the plan from early on you started college career and, like, life science, that's where I'm going, buddy. Or was it a little less intentional? I know I know for myself, like, my trajectory, not very intentional at all.

Mike Romance: 23:05

But, well, can I turn it around, interview you, and start asking you about how you got into your

Aaron Moncur: 23:10

trajectory, sure? Yeah, next podcast.

Mike Romance: 23:13

Okay, I think we need to do an, you know, Aaron podcast, and I'll moderate it, and we'll do becoming an engineer, right?

Aaron Moncur: 23:21

That would be fun. Yeah, it would.

Mike Romance: 23:24

And we're gonna do that all right. So how did I get into it? Well, I don't want to close any doors, right, because that's, that's the first thing. So I appreciate, like I said, industry X point. Oh, all sorts of industries. I graduated Cal State, Long Beach, you know, Orange County, California. And a lot of the engineering graduates were going up to Boeing and aerospace, and I had worked a little bit in commercial and aerospace early on in my career, and I liked it, but, you know, it seemed so focused on and you hear this, people say this all the time, or at least in my industry, they do, oh, I didn't want to go design a bracket or, you know, and spend my whole career doing that. I think that's wrong. That's totally not what it is. But when you're young, it's, you know, you know, I guess if you're in military, defense or aircrafts, you know, a lot of times that passion will drive you to some of those big aerospace companies. For me, I wasn't as interested in that. I wasn't a car guy or plane guy growing up, which a lot of people are, and I love that passion. I just it wasn't my exposure. So I ended up going down to San Diego after graduating to follow the beach, right? I mean, that's, you know, I know you know this. You came from an island. I know this, yes. So, you know, at that time, I'm like, Cool, great. I hear about this, you know, biotech beach down in San Diego, and I'm gonna go see what happens. And then, then you start to realize that the first company I got into, they're not around anymore, but it was a microarray company. And you guys start learning about, like, DNA and, you know, arrays and targeted and, I mean, the easiest way to think about this is covid, right? Covid was an early time for all of us, but covid, you know, when you take lateral flow test, there's there's one sequence, or let's call it that there, if you have it in your sample, it lights up on a lateral flow test, right? That's just how they work. But there's technologies that are more complicated, like micro arrays, where you put a whole bunch of spots down on a film or a substrate, and they have a bunch of different sequences, and you can learn a lot of things. And then there's DNA sequencing, and I'm just explaining to you how explaining to you how I got into it, and I just, my mind grew. I was like, I didn't know there's a career in industry around this, so I've been there ever since, and then being an engineer and an operations guy and that, you know, at that time, you know, I was like, Cool. I'm one of the, you know, everyone else are scientists, and I get to be around all these brilliant people on pH. Is developing this. Not just tell me how to make your product, I'll make it over and over again, you know. So that's I got into it for, you know, I'm from California. I love California. Ended up in San Diego, and I've been down here forever now, and I love it, and do everything I can to stay down here. But cool applications I could go into, kind of some of the, you know, the companies I'm seeing, and some of the roles and some of the engineering where I see that, you know, is so much more research oriented. But honestly, it'll make me feel stupid, because I don't know enough about the science yet, but there's a lot of cool stuff going on in our industry, for sure.

Aaron Moncur: 26:19

So speaking of scientists, I'm curious about this. I'd love to hear your take on it, because most engineers, I would say, don't work. We don't have the opportunity to work directly with scientists. Now, as an engineer, we, of course, understand that there's a very real difference between a scientist and an engineer, even though there's also some some overlap. But folks who maybe aren't part of our industry, they might hear the two words and kind of think they're the same thing, right? What has it been like working with a team of scientists who don't have an engineering background, but do have obviously a science background? What like, what are some of the challenges you've encountered, what have been some of the like, the real positives that you loved about working in that kind of

Mike Romance: 27:08

environment, I guess, you know, I'm a people person. I'm an extrovert. I think people who know me know that, so I do find I get inspired by just learning what people are passionate about. And, you know, scientists are not engineers. I don't want to say that that's a horror. That's actually not correct. But scientists, there's this freedom of thought you get as a scientist versus an engineer. And again, I'm a manufacturing engineer, so you know, I've done the mechanical thing, I've designed before, but you know, I don't get as much freedom in design and freedom and, you know, I actually take designs and make them work really well and consistently. So my mindset goes back to I'm a little less creative, although I'm trying to apply some creativity to what I do. I talk to you about kind of different approaches, you know, using AI, trying to grow outside of what our traditional training was. But, you know, in a lot of ways, scientists, the passion is just absolutely incredible. With scientists, they're specialized, you know. But, you know, it is a discussion, and it's a needed discussion, especially as you're transferring technology. You're transferring, you know, some novel test methods, you know, bio processes that we have to bring from you know, that they develop that are just, just, you know, novel, and they work really well once, and they have them in a loud notebook. I mean, these are kind of the traditional toggle tugs between, you know, operations and some of that. But I found it as a such a good partnership to build those relationships upstream and try to actually explain what you do, right? Actually have, there's a there's a colleague of mine, a peer of mine, who I love, and he's total science and I'm total engineer, and he's like, I don't want your job. He's like, I respect what you do. He's like, I hope he's listening. I shall forward it to him. But he's like, I do not want your job. He's like, you do your stuff so well, we need to create the product. We need to create, you know, this, this stuff that we're trained in, and go through the research articles and really understand it. We'll make a product out of it, and then you help us bring that to something that can be made over and over again. I really you have to, you have to work with people that are of a different mind, and I think that's very important. And, you know, in all of our careers, I think nowadays too, I think, you know, some of the younger generations who may not have the tech or trade training that we might have. I mean, I grew up in machine shops and talking to the machinists, right? I'm sure you did too some, some, I still don't like 3d printing because I'm used to catting for machining processes. 3d printing makes it like, just, you can almost make whatever you want, you know what I mean? So trying to be

Aaron Moncur: 29:42

printing, you

Mike Romance: 29:44

said it. I didn't, but, uh, you know, but are you a lazy designer? Because, you know, it's a new process that can do has less constraints than some of these old ones. So, you know, I'm trying to turn, to lean into kind of some of the new but I think that's the most important thing, is, I think everyone's passionate, and when you really are all on one team. So I think it's an, you know, working with scientists, they have a different mindset. And I think, you know, like everything else, grab as much as you can, because you're going to get it down

Aaron Moncur: 30:13

the way. Yep. Okay, so you are an operational leader. You lead teams internally. You You also, on occasion, will lead external teams, or work with external teams. How do you decide when a process or, or, you know, something should be, should be maintained in house, versus, want to make sense, to bring, you know, some external, external resource in,

Mike Romance: 30:39

yeah, so kind of the rule of thumb, at least in, kind of, you know, in. The Life Science trade. I work a lot with reagents and Phil finish, you know, Phil putting a cap on, and label totally glamorous. You it's just super sexy, super sexy. But a lot of times we keep that internal, because some of those formulations are, you know, a trade secret. You know, you don't want them necessarily getting analyzed is easy. I mean, I guess when you make them into a product, that's one thing, but early on, you try to keep that stuff close to your chest. I will say for me, I don't know. I mean, you know, I don't want to pretend I can do an manufacturing or set up an operation better than an external partner. But a lot of times, you just don't have as much to be as an external entity you're treating, you know, you have customers, and you have a lot of customers, right? And I think, you know, there's time and place, like everything else, you know, costs, it's more, it's more about, I think, control and understanding the process, and again, bringing it back to where I'm from. You know, a lot of the stuff we're doing very much conceptualized and fast tracked over to some sort of productization. And if you outsource that too fast, you're you're not taking the time to learn it and to learn the pain points, and to be able to even express your requirements to a vendor. So you talk about supply agreements, you might not know your demand like there's so many reasons not to. I think if cost is, you know, you know, I guess in cost could be, cost could be, hey, we don't have lab space or not or space for this operation, so we can't spin it up. Let's go out outsource. But you just have to, you have to understand the pros and cons, right? So some processes might be more amenable to do so, especially if they can do multiple operations on it while they're out there. But I think, like, I would never go try spin up an injection molding process. There's just no reason for that, right? But, you know, heat staking, assembly labeling, where you're really trying to get, you know, you understand these requirements. So I can come to you and, you know, build a case to do automation. And then maybe, maybe it doesn't make sense. Maybe, after you do all that, you know, investment and and assessing of the cost of the capital and the team that would be required to get across the finish line. Maybe, maybe you do find an outsourced partner to do it, but I think early on, especially like, you know, I think you'd be a bad I hate saying things like, hard like that, but I don't think you'd be. I think you'd be doing yourself a disservice if you outsource too quickly without really understanding the product you just produced.

Aaron Moncur: 33:06

Great insight. Yeah, I love that you talked earlier about scientists, and perhaps they have a little bit more conceptual freedom in the way that they work, versus an engineer, especially someone in operations manufacturing, like you. At the end of the day, your deliverable is a physical product that needs to be made within the constraints of physics and manufacturing processes. A huge part of that happens not the day you turn on your assembly line, but months or even years earlier, when design decisions are being made, and DFM principles are being considered. How do you think about good DFM with within your teams? Like, where does that start? What kind of conversations are you having? Who are you having those conversations with? For you know, the most successful teams that just seem to waltz into production with with less problems than they may have had otherwise.

Mike Romance: 34:11

Yeah, you know, I've seen it in various phases, slash, you know, maturities of industry. But I personally, and I'm open to conversations about this, and try challenge me, challenge me on this. But I think you need an operations and manufacturing, you know, SME, if you're if you're designing a product, if you're thinking of designing a product, if you're designing a product that you intend to eventually mass produce, whatever amount, quantity we're talking mass. Maybe it's only 100 of them, or maybe it's, you know, 10,000 or, you know, you you need somebody with the other side of the fence there to help consult and just even be part of the conversation. I've served that role many times. I love it. It's a tough one, because sometimes I feel like the upstream teams can feel like you're maybe not as, you know, technical or aware again, because they're just in the their coding, they're writing stuff, they're testing right? It's really hard to dedicate your time to being in all that meetings, but I think what you do there is the transfer is so much easier because you have somebody who's going to inherit this at some point, you know, downstream, let's call it operations, and they don't have to ask as many questions. They feel comfortable. They feel like they were briefed. It's a weird role to play because I'm doing it now. I've been doing it because you almost need to separate yourself from the ongoing day to day, if there's an operation in place, and become a consultant upstream. Yeah, it's not, you know, who are you in operations to come tell me how to make my design, my novel product. It's not about that. It's about partnership. It's about convincing both sides, you know, cross functional leadership, that it's the right approach. And even if you don't come up with as a consultant or as a DFM expert, you don't have the best ideas, or maybe they're not adopted for some reason. At least you were part of it, and you've challenged it. And I think that's how you drive, you know, fast transfer, robust processes, and, you know, ideally, highly manufacturable processes. Now I've seen it in the other way around, where you kind of wait, you know, you you ramp up, you scale a product that maybe was developed early on, without any insight, and it's painful. I've seen this several times, and it's costs, a lot, lots of visual inspection, lots of subjective decisions, you know, you know, minimal specs, but you're scaling that, and especially if that becomes successful, like the reactive, the pain, the quality, I don't want to call it impact, per se, but the level of oversight and kind of the the cost of that, the cost of the quality at that point, becomes so much more expensive, right? And then you're always saying, I wish I would have done that. I wish I would have done that. So 8020 rule maybe you get, you know, 20% of the big, big items, but it helps you with 80% of the reactive impact at the end. That's, that's a win win in a lot of scenarios. So yeah, did that answer your question? I kind of went a little it did.

Aaron Moncur: 37:51

No, it did perfectly. Yeah. I'm kind of bouncing back and forth between, like, pretty technical questions, and then in the more, more general, higher, higher level questions. So I've got another high level question for you. So your your your time at Quantum psi coming to an end right now, and you're starting to look for your next adventure, your next opportunity, as you consider your next role the future. What? What energizes you like? What would you be super excited about, if you want to connect with other engineers beyond the podcast, you can join the wave, our online engineering community. It's a place for engineers to actively learn, share ideas and engage with people doing similar work. That's the wave. Dot engineer. Thank you. You

Mike Romance: 38:51

um, you know, kind of the older, more mature I get, I'm also, you know, wanting to do a lot of different things. I really just want to, you know, I think it's important for everybody, actually, satisfaction with the team the company and the partners they have, whether it be scientists or engineers. You know, I'm getting less, you know, I've worked on a really a lot of really novel stuff. I can't talk too much about my current company, just because I didn't pre grease this. But you know, what they're working on is never been done before, at least in my opinion, or at least commercial, commercial. I've seen some pretty amazing things that these guys have developed, guys and gals. I try to correct myself all the time on that, but so that's kind of, you know, I was following a passion of where science was cutting edge and, you know, life science, product products were going. I've kind of fallen back in the people phase. I think I did a lot of really cool stuff in the last three years. Love managing a team. Love operators, quality. So I think I'd like to be part of kind of the the org, less about engineering focus, although I could do that too. But the the people you hire are getting so good, right for me, I want to be a thought leader and a people leader. That's, that's my goal. So I think anywhere I can, you know, whether it be aerospace or life sciences, anywhere I can contribute there and have just a team that really wants to, like, like, push the boundaries of collaboration. That's, that's huge for me right now. I want to learn from people kind of in that phase in my life right now. So let let some smart people do the work

Aaron Moncur: 40:31

along those lines. I think a lot of people underestimate, like the human side of engineering and manufacturing operations, right? How has emotional intelligence shaped the teams that you've led?

Mike Romance: 40:46

I want to say it's helped. I mean, I've been part of, you know, orgs where, you know, it feels like there wasn't the leadership was more. See, I hate saying results driven, because it's not about you don't have to be one or the other, right? But I think, I think in you're seeing it, and you're bringing out a lot in this conversation, like, as much as engineers want to think you could put constraints on everything and black box and and really say it has to be this way, like, that's not how it works. In my industry, aerospace, big, mature organizations, maybe there is a right way to do things. But I think, you know, I, as a leader, had to one. I have to admit that I'm, you know. Using my you know, and I'll admit this any day, that's part of the emotional intelligence, I guess. But, you know, they're people are going to do the job better than me. They just can. But bringing people together, bringing the right conversation together, you know, that's something that I hope I can contribute. So, you know, I think it goes back to I've seen some really smart, really non emotionally intelligent people do really amazing things, right? But I think the rest of the team can suffer. Like, this is all leadership stuff, right? You can read books about this. I've read books about it like, I think, I think, as a leader, we owe it to our teams to clear the path, provide some direction. But you know, even in our engineering world, right, where there is, like, you know, maintenance got to get the maintenance done, right? Like it's, you have to, there are rules to follow. But outside of that, I think everybody's starting to look for some meaning in their work, right? And providing that meaning, providing the conversations and learning. I mean, humans are human, right? Until there are robots. We have to, you know, in order to, I think, get the most out of people, we have to satisfy, you know, the non machine elements of people. If that makes

Aaron Moncur: 42:36

sense, it does. And as engineers, that can be tough, right? Like stereotypical engineer, we like to be alone, working on CAD or something on the computer, right? We're not known universally for being the most people oriented discipline, but at the end of the day, everything that we do is with and through people, so the more and

Mike Romance: 43:00

more these days, right? You got to publish your, you know, work even internally, and get cross, you know, reviewed by other, you know, leaders and other parties. Like, it's very social, actually, if you think about it again, in my world, I don't want to pretend I have lived in some of these other industries. But, you know, the other thing too is, like, my world is, is about people. It's about the line. It's about the people on the line, the quality team, you know, the manufacturing hearing or racing to keep the lights on and solve the problems of the day, but also execute on projects, right? I'm not a design engineer. I've done it. I love design. I respect that's why I hire you guys to do professionals at it. And you guys can, you know, make amazing and you have creativity too. But for me, a lot of what I do in manufacturing engineering is manufacturing based, it's people based, process based, right?

Aaron Moncur: 43:49

So let's dig back into that, the manufacturing, the operations. Let's say that you were to inherit a line somewhere, and the line is either maybe it's struggling a little bit, or maybe it's just kind of being brought up. It's a new line. What are some of the first things that you start doing or looking for to make that line successful.

Mike Romance: 44:11

Yeah, you had another question that I was laughing about. It's like, how do you know? I think it was along the same lines, how do you know if a pilot line or equipment is you know, how mature it is or and it's a liability, something like that, yeah. And I think my, my instinct is, is or 5s tape around it, right? I'm, you know, I there's, what did, what did I have, you know, work constructions, of course, but I think, you know, wiring got I inherited something that that looked really cool, did some really cool stuff, but I opened up the controls cabin, and it was a bird's nest in there. And I was like, Oh, my God, right, you're having a heart attack thinking about that. But that's how we do it, right? And there's nothing wrong with it until you have to maintain it. So, you know, I guess the first things I would do, and firm believer of this method, I think you can call it a QBD, quality by design, or CPM, critical parameter management, or, you know, emerge of both. But you got to map your processes steps out, and if it's not done already, right, it gives you a tangible element to say this occurs, whether the human behavior or machine behavior even inspection and QC, right? And just map it out, break it down, map that out and really understand your inputs and outputs for each process step. And do you have a Do you have control on that? Are you measuring and monitoring said stuff? So, you know, another key indicator of something that's been, you know, transferred or put into production too fast, is there's no, like, real QC or in process QC around it, right? You know, is there a vision system next to it? Is there a torque? A torque tester, if you're talking about caps like that, that shows you somebody's thought about that process and how to measure it and how to make that data available? And that's kind of goes back to this digital transformation kind of stuff, because even a simple process like capping a threaded tube, right, there's a quality attribute that you care about, and that means that the caps on, well, right? You need to be able to measure that, and if you can't measure that, then you really don't know if your process is doing well. You can say it looks good, but that only gets you so far, and that's a simple way to do it, but that's what you apply to your processes, no matter what they are. And you can start to generate, you know, I guess. Uh, you know, levels of risk for various elements in each of them. And then that's helps you prioritize where you go after first, right? But doing that stuff early and having that mindset, again, goes back to kind of the early DFM, and sitting on the line with the rd teams is okay, that's great. Well, on the side, you can as a consultant, because it feels like that, but also start to do the mapping for the team and start to show them where there's gaps, and start to help, help get ahead of them, so you can walk up to a pilot line, and that's it's done, right?

Aaron Moncur: 46:54

Yeah. Can you think of a story or an experience where there was some technical decision that was made and it led to some long term operational consequences, whether they were good or bad, I think either one would be instructive. But is there like a story or an experience that comes to mind that that you could share with the audience?

Mike Romance: 47:17

Yeah, I'll do my best. There is one right now. It's a lot to get into, and I'll ramble, but I'll try to summarize this in something that I can't explain because we have a DFM situation with a new product, that new kind of, let's call it packaging approach. There's two ways to do it. There's a highly modular, highly reworkable way, and then there's kind of more of a constrained, fixed, less reworkable Way, which could, you know, result in lots of scrap if there's something that went wrong with it? And we, you know, partnering with, you know, the VP of Engineering and some of the upstream folks spent a lot of time doing a Pew chart. If you haven't done those, or they can be super helpful, for sure, but trying to weigh out this architecture decision we wanted to go forward with. And all of us, even my instinct, was, stay modular, right? You know, we can talk about, you know, automating, you know, jump into a full line. You start with modular, you make sure they work. You understand those processes before you link them all together. In this case, it was a product design or architecture, and it made sense, because it potentially allowed for rework to save us lots of money in scrap. And, you know, even QC, the ability to throw in different components to kind of QC it so that you don't have to, like, again, I'm trying not to give away what it was doesn't really matter. But, you know, there's a lot of value built up, and if you had to scrap that, it would be a lot of loss of productivity and cost, right? Yeah, so we went with that. It weighed pretty highly to go to that modular approach, but that is going to set us up for a very nothing's, I don't want to call unmanaged in, you know, harder operation scale when we get there. Now, the goal is to kind of pivot to that kind of more fixed approach later in the more fixed design. But if we don't do that, and I'm going back to automation, we can have to scale something that's very painful. Now it is going to save us money early on in development and with QC and learnings, but it's also going to be a, I don't want to call it disaster. Nothing's a disaster, but it's going to be kind of painful to scale up. Yeah, so I think, I think time and place, like we've talked about, really understanding it, but you really have to have an understanding of when that inflection point happens, and when you have to start the transfer into this new design, so that you're not scaling up something that isn't meant to scale.

Aaron Moncur: 49:45

If that makes sense, timing becomes critical there,

Mike Romance: 49:48

yeah, which is hard, right? You need budget. You need you need buy in from your leadership, right? I mean, that's, you know, I'm not creating my budget, right? That goes up to finance. So there has to be, you need to know what data you need to kind of trigger that. So it goes back to, like, this, proactive thinking, really, you really, really should have somebody early on for that stuff, it really helps. Yeah, I think.

Aaron Moncur: 50:11

All right, just a couple more questions, and we'll wrap things up here for for those listeners out there who might be building or scaling manufacturing teams today, what's one principle that you wish more leaders internalized

Mike Romance: 50:30

for building and scaling a manufacturing team. I think my my gut goes to, you know, your early team, that is the foundation prior to scale, is going to be so important to take care of and, you know, nurture and listen to their needs and wants, even if it's outgrowing the team, if not, because you're going to rely on them for their knowledge base, for their experience, and it's, you know, you can scale around them. But if you lose them, and you lose some of the tribal knowledge and commitment, you have culture, culture impacts. You have, you know, tech debt impacts, and I've seen it, so I think it's really easy, you know, I'm sorry. I'm just thinking about how some of this stuff, I don't want it to be controversial for anybody, but some of this stuff, you know, like, people are the most important tool we have, you know, and especially if you're. Going to go into a high growth, high scale, at least in my area, where, you know, some of this stuff isn't trained at a school. You need time to mentor and develop like, you know, you got to make sure your core team is intact and healthy and has a culture that respects one another, right? Because you've used that, and again, the pay, you know, the cost of poor quality of personnel can hit you, right? So I guess that's my advice. Is just, you know, your team is really until you got everything documented and matured and tried and true and you got training plans and skills gaps, you really have to rely on that main team, and keep them, you know, motivated, and they want to do it too. They want to see the success of the you know, actually, one of the notes I had is, by the time you have to do make that decision, you know, the existing team might be burnt out and or, you know, tax, because they have helped you get to that that point. And now you're in a scaling mission, right? And you want them rejuvenated. You want them ready for the next phase, which could be bigger and harder. So goes back to the whole people thing, right? People are, yeah, so don't even start it. I'll start. I'll start getting into, like, politics and stuff that's that's going on in daily life today. And boy,

Aaron Moncur: 52:43

that's that'll be in the next episode, right?

Mike Romance: 52:46

That would be one, okay, I'm still interviewing you. You know that, right? Oh, I can't wait. I'm looking for masculine interview. One of these, something's gonna happen.

Aaron Moncur: 52:56

Well, I just want to piggyback on what you were saying about people, because I feel the exact same way, like it really all goes back to the people at the end of the day, and it's like, I almost feel like it's cliche. You know, everyone talks, oh, your people are your most important asset, blah, blah, blah. Well, it's true. So I've been running pipeline here for 16 years now. And I think this is gonna sound strange to say, but I think engineering services is a bad business model, like, if I was in this just to make money, I would not be doing engineering services, because it's it's a tough business. It can be a tough business, and we are so blessed to have just some truly spectacular people here at Pipeline. Everyone pulls their weight. Everyone gets along. We actually like each other. We work well together. Just people help each other. And honestly, I don't know if pipeline would be around still 16 years later, if it weren't for the quality of our team members, like people just do the right thing. You know, they pitch in, they make sure things get done. And it is, it's, it's amazing. But just to restate your point, it all goes back to the people like you have to build an except an exceptional team of people,

Mike Romance: 54:17

and I'm gonna give you, you know, half for all the credit, right? And no one should take all the credit, but someone has to define that culture. And you know, you, you built the culture right? And you are hiring people and selecting people who are competent and who are passionate, like you and respectful, and if they're not, you know, maybe it's, you know, they're suited for a different house. But your, your house that you have built is is successful, and that's kind of, I think the point I'm getting across is, until you're a big, big entity, and you have so much, you know, behind you, and so much dollars to spend and repair things like your small team is, is your team? They're creating the value, right? You just have to be there to get out of their way. I know that's you're there to talk them through everything and advise and be a support, right? And it's not that you're fully getting out of the way, like it is still something. It's your dream, it's your passion, it's what you built. But I think that just applies to anything, right? For any team leader, it could be a big team, it could be a company, it could be a small team, right? You know, you talked about my expression of conscious leadership. I think you mentioned that, or what I think it's like when I realized that I'm like, you know, that's, that's my job, right? Set people up for that success. So, no, I'm happy. I'm happy we crossed paths. Happy you got me on here. You know, it's a, I'll be honest, it's an interesting time right now. It's the second time I've gone through a round of layoffs. And, you know, I don't wish it on anybody, but it sure does help you. Look inwardly and look at the value you provide and what you want with your life and how you can contribute. And I don't think there's anything wrong with it. I think it's it's good to be in this situation, but, yeah, it's painful, so, but you got my back. Look at that. I mean, you know you had me on the show all I asked for a good conversation. Remind me that what I do is valuable.

Aaron Moncur: 56:05

That's all I want, absolutely, absolutely for all of you out there listening to this episode, if, if you know of a role or an opportunity that you think Mike might be a good fit for, by all means, please reach out to him. He's on LinkedIn. I think you're the only Mike romance on LinkedIn. If not, you. Will. You'll find him pretty quickly based on the background. But anyway, he's just a stellar stand up human being. Very talented engineer has my full endorsement, and I hope this episode helps to just, you know, get get him some visibility and generate some new opportunities. So with that, I think we'll wrap things up here. Mike, any any final words, anything else that we should have talked about that we didn't get a chance to

Mike Romance: 56:52

No, I thought it was, I thought it was great. There's a lot more, if you ever want to just, you know, I didn't do this for charity. I'm not trying to, trying to find a handout based off of this. I actually, truly am passionate about this. But if you ever, you know, need to fill in for you know, more focused topic, I'm I'd be happy to do so, and I will. So that's gone.

Aaron Moncur: 57:12

Awesome. Okay, all right. Challenge accepted. All right. Mike, well, how can people get in touch with you if they do know of a good rule, what's, what's the best way for them to reach out to you?

Mike Romance: 57:23

Yeah, I mean, you can find me on LinkedIn. It's pretty easy to do micromanse in San Diego, but you could reach out to Aaron too, and you can tell you about his services. That won't hurt either.

Aaron Moncur: 57:34

That's kind of you to say. All right. Well, Mike, thanks so much for sharing some of your wisdom and experience with us today, and we wish you all the best,

Mike Romance: 57:42

you guys too. Thank you. Thanks a lot.

Aaron Moncur: 57:46

I'm Aaron Moncur, founder of pipeline design and engineering. If you like what you heard today, please share the episode to learn how your team can leverage our team's expertise developing advanced manufacturing processes, automated machines and custom fixtures, complemented with product design and R D services. Visit us at Team pipeline.us. To join a vibrant community of engineers online. Visit the wave. Dot, engineer, thank you for listening. Being an engineer has more than 300 episodes, and you don't have to listen to them in order. If you're dealing with a specific challenge right now, there's a good chance we've already interviewed an engineer who's been through it. You can jump around, search by topic and listen to what's most relevant to you. See you on the next episode you.