Firmware Engineer

We are seeking a Senior / Staff Medical Firmware Engineer with deep, hands-on experience developing regulated medical device firmware to join our growing medical devices team.

Key Responsibilities

Design, develop, and maintain safety-critical embedded firmware for regulated medical devices, with a focus on insulin pump systems.

Lead firmware architecture, requirements definition, and design from early concept through product release.

Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971.

Act as the firmware compliance leader, guiding the team on requirements management, traceability, risk control implementation, verification strategy, and evidence generation.

Work closely with Quality and Regulatory teams to define, implement, and maintain firmware-related QMS processes, templates, and work instructions.

Produce, review, and approve key firmware deliverables including requirements, architecture and design documentation, risk analyses, traceability matrices, and verification reports.

Skills & Experience

5+ years hands-on experience developing firmware for regulated medical devices, with products that have reached clinical, commercial, or regulatory submission stages.

Demonstrated experience working within an ISO 13485–certified Quality Management System.

Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied to software.

Strong embedded programming skills in C and experience developing robust, maintainable safety-critical code.

Experience producing audit-ready and submission-ready software documentation and compliance evidence.

Experience collaborating closely with Quality, Regulatory, Systems, and Hardware engineering teams.

Experience supporting FDA submissions (e.g. 510(k)) and/or EU MDR technical documentation is highly desirable.

Experience establishing, improving, or scaling firmware development processes in a regulated environment is a strong advantage.

What Success Looks Like in the First 6–12 Months

Firmware development for the insulin pump platform is established and operating consistently within the ISO 13485 Quality Management System.

Clear and well-understood firmware lifecycle processes are in place and followed across the team.

Requirements, risks, implementation, and verification are fully traceable and audit-ready.

The firmware organisation demonstrates confidence and maturity during regulatory interactions and audits.

Firmware engineers are coached and empowered to deliver compliant medical device software independently.