Electronic Engineer

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 (phone number removed). * 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 (phone number removed) essential performance assessment and IEC (phone number removed)-2 EMC Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy