At a Glance
- Tasks: Design and develop firmware for cutting-edge medical devices, focusing on insulin pump systems.
- Company: Join a leading medical devices team dedicated to innovation and safety.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with strong focus on quality and compliance.
- Why this job: Make a real difference in healthcare by developing life-saving technology.
- Qualifications: 5+ years of experience in regulated medical device firmware development.
The predicted salary is between 63000 - 77000 £ per year.
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 13485certified 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 612 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.
TPBN1_UKTJ
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