At a Glance
- Tasks: Design and develop firmware for life-saving medical devices like insulin pumps.
- Company: Join a pioneering medical devices team in Cambridge.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on quality and compliance.
- Why this job: Make a real difference in healthcare by developing critical technology.
- Qualifications: 5+ years in firmware development for regulated medical devices required.
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.
- #J-18808-Ljbffr
Firmware Engineer (Medical) - CambrIdge employer: American Society of Civil Engineers
Join a dynamic leader in BMS control systems in Greater Belfast, where you will thrive in a supportive work culture that prioritises employee growth and development. With an attractive salary package, including a company car and pension plan, you will have the opportunity to manage exciting projects while building strong client relationships in a collaborative environment that values innovation and teamwork.
Contact Details:
American Society of Civil Engineers Recruitment Team
We think you need these skills to ace Firmware Engineer (Medical) - CambrIdge
Embedded Firmware Development
ISO 13485
IEC 62304
ISO 14971
C Programming
Safety-Critical Code Development
Requirements Management
