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 & 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 organization demonstrates confidence and maturity during regulatory interactions and audits.
- Firmware engineers are coached and empowered to deliver compliant medical device software independently.
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.
- Opportunity to shape new products and processes from an early stage.
- Join a company with a strong track record of innovation and patent leadership.
#J-18808-Ljbffr…