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 quality.
- Benefits: Enjoy hybrid working, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on compliance and career advancement.
- Why this job: Make a real difference in healthcare by developing safety-critical 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 - Hybrid working in Cambridge employer: microTECH Global LTD
Join a pioneering team dedicated to advancing medical technology, where your expertise as a Firmware Engineer will directly impact patient care. Our hybrid working model promotes a healthy work-life balance, while our commitment to employee growth ensures you have access to continuous learning and development opportunities. With a strong focus on quality and compliance, you'll thrive in a collaborative environment that values innovation and excellence in the regulated medical device sector.
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We think this is how you could land Firmware Engineer - Hybrid working in Cambridge
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We think you need these skills to ace Firmware Engineer - Hybrid working in Cambridge
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How to prepare for a job interview at microTECH Global LTD
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Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at microTECH Global LTD that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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