The first engineering leader medtech founders keep getting wrong

There is a hire we see medtech founders make, then unmake, then make again. It is the first Head of Engineering at a venture-backed medtech that has just crossed the line from prototype to product - a wearable ultrasound firm, a novel implantable, a diagnostic imaging platform. The brief, almost without exception, is calibrated for the company they were two years ago. The hire is impressive on paper. The hire leaves, or is asked to leave, inside eighteen months. The founders come back and start again.

We have run this search often enough to describe the pattern precisely.

The person the founders think they need

The brief usually reads like a Head of Engineering brief for a scaleup. Someone with team-scaling experience. Someone who has built a platform. Someone with the modern engineering toolkit. If the founders are ambitious - and they always are - they want someone from a recognisable brand. Cochlear. ResMed. Sometimes a US name.

That candidate profile is not wrong. It is incomplete.

The medtech Head of Engineering hire has a second dimension the founders often underweight, and it is the dimension that decides whether the person survives twelve months. It is the ability to operate inside a regulated development process without treating it as an obstacle. Every senior candidate we screen has some exposure to ISO 13485 or IEC 62304 on paper. Fewer can describe, from memory, what changes about their day when a design becomes locked and a change requires a formal risk-assessment review. Fewer still have shipped a device through a TGA or FDA submission and understand what post-market surveillance actually costs.

The founders who hire well are usually the ones who ask the second question hardest.

The candidate the founders end up needing

The candidate who lasts, in our experience, has three things.

First, they have shipped commercially inside a regulated environment. Not “worked on a project that eventually got approved.” Actually held the pen on a submission. Actually stood up under a corrective-action response. Actually watched a hire they made fail an internal audit and had to explain it. There is no meaningful substitute for this.

Second, they hold both languages. They can talk credibly to the founder about roadmap, staffing plan, technical bets and speed. They can also talk credibly to the QMS lead about design controls, verification and traceability. Most senior engineers we screen are strong in one language and functional in the other. The candidate you want is strong in both.

Third, they understand that the timeline is not negotiable. The most common failure mode is a hire who accepts a founder-set timeline that assumes regulatory work will compress. It will not. The timeline breaks. The hire is blamed for the breakage. The hire leaves.

What we push founders to do at intake

We push three things.

We push the founder to spend a serious hour on the regulatory pathway before we take the brief. If the pathway is not clearly articulated, the candidate we recruit will be the wrong candidate.

We push the founder to talk to two or three of their peer-founders in medtech about who they have hired well and who they have hired badly. The stories overlap. The lessons are the same.

We push the founder to widen the search geography earlier than they want to. The realistic Australian senior medtech leadership pool is maybe forty people at any given moment. Half are not moving. Of the other half, maybe five will fit a specific brief. That math forces early conversations about international candidates - and about relocation packages that reflect the seriousness of the ask.

The economics of getting it right

The cost of getting this hire wrong is not just the wasted salary and search fee. It is eighteen months of engineering leadership drift at exactly the wrong stage of the company. It is a submission that slips six months. It is a series-B round that gets marked down because the technical story looks less coherent. Founders we have worked with who ran the search seriously the second time uniformly say it should have been the first search they ran seriously.

The medtech firms scaling successfully in Sydney right now are, without exception, the ones that made this hire well.