Copenhagen, Denmark
Cambridge Mechatronics Ltd (CML) is a globally recognised fabless semiconductor
company headquartered in Cambridge, UK. CML is pioneering Shape Memory Alloy (SMA)
actuator systems that deliver breakthrough performance in high-precision, high-volume
applications such as smartphones, AR/VR head-mounted devices, and compact medical
instruments.
With a multi-disciplinary global team spanning materials science, mechanical design,
electronics, control algorithms and software, CML develops complete actuator system
solutions — including the SMA actuator, control ICs, and advanced algorithms.
CML holds approximately 850 granted and pending patents and ranks among the top 25
UK patent filers, reflecting our strong commitment to innovation and technology
leadership.
We are seeking a highly motivated Medical Firmware Staff Engineer to join our growing
medical devices efforts. Working closely with the medical devices and firmware teams,
you will play a key role in the development of firmware for our next-generation insulin
pump platform.
To fit this role, you have already delivered medical device firmware in a regulated
environment, understand what it takes to achieve and demonstrate compliance, and
can help lead the firmware organization in executing compliant medical firmware
development. This is an exciting opportunity to contribute to life-changing medical
technology within a fast-paced, innovative environment.
• Design, develop, and maintain embedded firmware for medical devices, with a
focus on insulin pump systems
• Collaborate closely with the medical devices and cross-functional teams
(firmware, hardware, systems, control algorithms, quality, and regulatory)
• Contribute to system and firmware architecture design decisions and
requirements definition
• Implement robust, reliable, and safety-critical code in compliance with medical
standards
• Guide the firmware teams on firmware requirements management, traceability,
risk control implementation, verification strategy, and evidence generation
• Produce, review, and help approve key firmware deliverables including
requirements, architecture and design documentation, risk analyses, traceability
matrices, and verification reports
• Ensure firmware development is executed in accordance with a certified ISO
13485 Quality Management System, with practical application of IEC 62304 and
ISO 14971
• Support verification, validation, and testing activities, including unit, integration,
and system testing
• Help define and implement new development processes and best practices
• Support regulatory submissions and audits where required
• Stay up to date with international medical device regulations and standards
• 5+ years hands-on experience in embedded firmware development within a
medical device environment, for products that have reached clinical,
commercial, or regulatory submission stages
• Demonstrated experience working within an ISO 13485–certified Quality
Management System. Practical application of IEC 62304 medical device
software lifecycle requirements and ISO 14971 risk management as applied to
software is preferred
• Strong programming skills in C/C++ for embedded systems and experience with
developing and maintaining code for safety-critical or regulated systems
• Experience with low-power, real-time embedded systems and good
understanding of firmware-hardware integration
• Experience collaborating closely with firmware, hardware, systems, control
algorithms, quality, and regulatory engineering teams and producing audit- and
submission-ready deliverables
• Knowledge of and concrete experience supporting international regulatory
framework submissions (e.g. FDA, MDR) is an advantage
• Strong debugging and problem-solving skills
• Self-starter with the ability to work independently and take initiative
• Adaptable and comfortable working in a dynamic, evolving environment
• Willingness to introduce and implement new processes and improvements
• Strong attention to detail and commitment to quality
• Excellent communication and collaboration skills
• Work on cutting-edge medical technology with real-world impact
• Be part of a highly innovative and collaborative engineering team
• Shape technology, new products, and processes from an early stage
• Join a company with a strong track record of innovation and patent leadership
Application
To apply, send your application and CV to careers@cambridgemechatronics.com. We
evaluate applications on an ongoing basis.