microTECH Global LTD
Firmware Engineer
Cambridge
Posted about 22 hours ago
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Senior / Staff Medical 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.
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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.
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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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Skills
Embedded Firmware
C Programming
ISO 13485
IEC 62304
ISO 14971
Medical Device Development
Firmware Architecture
Risk Management
Requirements Management
Verification Strategy
FDA 510(k)
EU MDR
Safety-Critical Systems
Traceability Matrices
QMS Processes
Technical Documentation