Build internal verification and validation (V&V) capability including fixtures, protocols, traceability, and release gates.

Own practical QMS execution internally including design controls, ISO 14971 risk management, and supplier and change control, supported by external partners as needed.

Govern design transfer so manufacturing does not outpace evidence.

Expected timeline

First 30 days: engineering and quality risk and gap map across engineering, V&V, QMS, and suppliers; establish a testing plan to support RCT readiness; work with external partners on QMS development.

By 60 days: V&V engine running with key benches, fixtures, and protocols; requirements-to-test traceability backbone in place.

By 90 days: pilot build plan defined including manufacturing test and calibration approach; RCT baseline strategy defined with hardware, firmware, and software configuration control.

By 6 months: technically RCT-ready with a stable baseline, controlled builds, V&V evidence for trial-critical functions, and trial support and logging in place.

What we’re looking for

Strong embedded electronics or electrical engineering background (>5 years).

Hands-on experience with embedded firmware, timing-critical control, and embedded algorithms such as IMU or motion sensing (>2 years) .

Software and IoT background to manage clinic and home-deployed systems including updates, logging, and access control fundamentals (>2 years) .

Experience taking regulated medical devices to market.

Compensation

Salary plus meaningful ownership, with equity participation expected.