TECHNICAL SYSTEMS DIRECTOR (scope to become CTO) - Medical Devices | FDA / CE (EU MDR)
Cambridge or within daily commuting distance
Strong base + bonus + equity
Once-in-a-lifetime opportunity.
Solving one of surgery’s most expensive and deadly failure points.
We are building a real‑time, intraoperative platform that turns physiological signals into actionable data during surgery. The objective is simple: remove guesswork at the exact moment decisions matter most.
The problem is well understood, but still unsolved:
* Anastomotic leaks remain one of the leading causes of post‑operative mortality and re‑intervention
* Mortality can reach ~18% in early cases
* Re‑operation rates exceed 80%
* Downstream costs range from $35K to $121K per patient
* Detection today is still largely subjective
This is not a tooling gap. It is a data gap.
Our platform addresses this directly by capturing and structuring intraoperative signals in real time, enabling surgeons to make objective, evidence‑based decisions in the moment.
We are a category‑defining international startup building toward a new standard of care across laparoscopic, robotic, and endoscopic procedures.
This is a build‑and‑deliver role with clear ownership and real consequence.
This is a delivery‑critical engineering leadership role responsible for taking a high‑quality complex surgical system from advanced prototype, through design and development (using external partners), to securing regulatory clearance, and then through design transfer to external manufacturing for commercialisation.
👉 The mandate is simple:
Build it properly. Deliver it on time. Manage external design partners. Control costs. Get it through regulatory.
WHAT YOU WILL BE DOING
You will own the relationship with our external design partners, leading end‑to‑end product development from a late‑stage advanced prototype to pre‑commercial readiness. The prototype is already strong.
Your focus will be to manage scope, budget, and milestone delivery, holding our world‑class design partners accountable for timelines and quality. You will spend significant time on site with them.
You will use your expertise to identify risks early and resolve issues before they escalat.
We need strong systems engineering leadership across:
* Electromechanical hardware
* Embedded software
* Sensing technologies
You will oversee system integration challenges, make disciplined engineering trade‑offs, and support V&V and regulatory execution. You will also identify opportunities for IP generation.
You will manage the budget as if it were your own, controlling costs through design and ultimately leading manufacturing transfer to an external partner post‑FDA clearance.
This is a lean team, and this role is critical. It will be demanding, but you will be working with highly capable people, with strong support and autonomy. You will also build and lead your own team.
IDEAL BACKGROUND
* You have personally taken a complex OR‑based medical or regulated electromechanical hardware product from concept to near‑commercial or commercial stage (ideally Class II/III surgical systems with embedded elements)
* Strong background in electromechanical systems (hardware‑first, not purely software)
* Experience with flow, pressure, gas, sensing, or similar physical systems; robotics; endoscopic towers; or OR‑based electromechanical products
* Proven track record managing external partners and budgets
* Hands‑on when needed, not purely strategic
* Able to anticipate, troubleshoot, and evaluate alternative solutions, making clear and timely recommendations to the CEO
WHY JOIN? – A RARE, CATEGORY‑DEFINING ROLE
At its core, this role is about saving lives by removing subjectivity and replacing it with actionable, real‑time data.
There is significant scope to grow into the CTO role.
This is not just about building a device. This is an opportunity to:
* Establish a new standard for how surgery is performed and measured
* Take this platform beyond the initial application and build the foundation for:
o Standardised intraoperative decision‑making
o Integration into connected surgical systems
o Longitudinal data and outcome benchmarking
You will:
* Own a full development programme end‑to‑end
* Lead through manufacturing, commercialisation, and regulatory approvals
* Work on a problem with clear clinical and economic impact
* Hold equity in a startup with strong potential
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