At a Glance
- Tasks: Design and develop safety-critical firmware for innovative medical devices like insulin pumps.
- Company: Join a leading medical devices team focused on impactful healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on quality and regulatory compliance.
- Why this job: Make a difference in healthcare by developing life-saving technology.
- Qualifications: 5+ years in firmware development for regulated medical devices and strong C programming skills.
The predicted salary is between 60000 - 80000 £ 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 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.
Firmware Engineer in Cambridge employer: microTECH Global LTD
Join a pioneering medical devices team where your expertise as a Senior/Staff Medical Firmware Engineer will directly contribute to the development of life-saving technologies. Our commitment to quality and compliance is reflected in our ISO 13485-certified environment, fostering a culture of collaboration and continuous improvement. With ample opportunities for professional growth and a focus on innovation, you will be empowered to lead firmware architecture and ensure the highest standards in medical device software development.
