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.

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