Medical Firmware Staff Engineer

Teknologiens Mediehus; Ballerup; On-site; DKK 700,000 - 1,100,000; Full time

Job summary

Cambridge Mechatronics Ltd (CML) seeks a highly motivated Medical Firmware Staff Engineer to advance firmware for its next-generation insulin pump platform. You will drive compliant medical firmware development in a regulated environment and lead the firmware organization in executing high-quality firmware workflows.

Key responsibilities include designing embedded firmware for insulin pump systems, collaborating across firmware, hardware, and quality teams, and ensuring evidence generation for

Qualifications

• 5+ years hands-on embedded firmware development in a medical device environment.
• Experience with ISO 13485, IEC 62304, ISO 14971 risk management as applied to software.
• Strong C/C++ programming for embedded systems.
• Experience with low-power, real-time embedded systems and hardware integration.

Responsibilities

• Design, develop, and maintain embedded firmware for medical devices, focusing on insulin pump systems.
• Collaborate with cross-functional teams including firmware, hardware, systems, quality, and regulatory.
• Ensure firmware development aligns with ISO 13485 and IEC 62304, including risk analyses and verification reports.
• Support regulatory submissions and audits as required.

Skills

C/C++

Embedded firmware

ISO 13485

IEC 62304

Regulatory submissions

Medical devices

Debugging

Team collaboration

Job description

About Cambridge Mechatronics Ltd (CML)
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.

The Role
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.

Key Responsibilities

• 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

Skills & Experience

• 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

Personal Attributes

• 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

Why Join CML?

• 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

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