Send a text 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 The Wave is a place for engineers to actively learn, share ideas, and engage with people doing similar work. Learn more at thewave.engineer Subscribe to the show to get notified so you don't miss new episodes every Friday. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us Watch the show on YouTube: www.youtube.com/@TeamPipelineus
