What you will do

* Own the electronics architecture, schematic, PCB layout, BOM and supplier engagement for the device

* Design, and/or modify existing designs of the analogue electronics parts of the device, ensuring isolation and safety features

* Specify and integrate the power supply sub-system, including charging, protection, thermal management and low-power operation.

* Design and integrate sensors into the system as required.

* Take the early prototype through to MVP electronics design, supporting the build of 20 functional units

* Plan and execute essential pre-compliance testing, then manage third-party electrical and electronics related Validation and Verification testing (e.g. EMC, reliability)

* Produce regulatory-quality evidence: schematics, BOMs, test reports, traceability matrices, design history file inputs

* Support tech transfer of the electronics design to client's chosen Contract Manufacturing Organisation

* Operate inside ISO 13485 QMS with formal change control from the alpha prototype build onwards

Essential skills and Experience

* Medical-device electronics contractor profile. Track record on Class II / IIa/ III devices developed under ISO 13485 and ISO 14971.

* Active energy delivery to the body. Hands-on experience with design of devices for safely delivering electrical treatments to the body.

* Analogue electronics design.

* Battery-powered electronics. Li-ion / LiPo battery design; charging and protection circuitry; thermal limits; low-power operation

* Hardware safety design. Single-fault analysis, fail-safe interlocks, mitigation of hazards aligned to IEC 60601-1.

* Regulatory-quality engineering evidence. Comfortable producing schematics, BOMs, design verification test reports, and traceability matrices to a Design History File (DHF) standard.

* Works well inside ISO 13485 / ISO 14971 discipline alongside an internal engineering team collaborative, evidence-led, formal change control fluent.

Desirable

* EMC pre-compliance test management at third-party labs

* Experience supporting design transfer to CMOs (Design For Manufacturing (DFM) reviews, sourcing validation, soft tooling)

* Experience with sterilisation of electronic assemblies (ethylene oxide, gamma) and the design constraints these impose

* Familiarity with IEC 60601-1 essential performance assessment and IEC 60601-1-2 EMC