Medical Firmware Staff Engineer

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, 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 Senior / Staff Medical Firmware Engineer with deep, hands‑on experience developing regulated medical device firmware to join our growing medical devices team. This role is for an engineer who has already delivered medical device firmware in a regulated environment, understands what it takes to achieve and demonstrate compliance, and can lead the firmware organization in executing compliant medical firmware development. It is not a general embedded firmware role. Working closely with the Head of Medical Devices, Quality, Systems, and Hardware teams, you will play a central role in the development of firmware for our insulin pump platform. You will act as a technical authority for firmware compliance and help establish best‑in‑class medical device firmware practices across the firmware organization. This is an exciting opportunity to contribute to life‑changing medical technology within a fast‑paced, innovative environment. 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. Lead and participate in design reviews, code reviews, and risk reviews, ensuring regulatory and quality expectations are met. Support regulatory submissions and participate in internal and external audits and inspections as required and in accordance with the FDA "Content of Premarket Submissions for Device Software Functions". Mentor and coach firmware engineers, raising the overall maturity of the organization’s medical device software practices. Stay current with international medical device software regulations and standards and translate them into practical engineering guidance. Skills