At a Glance
- Tasks: Design and develop safety-critical firmware for innovative medical devices like insulin pumps.
- Company: Join a pioneering semiconductor company leading in medical technology innovation.
- Benefits: Competitive salary, career growth, and the chance to impact lives through technology.
- Other info: Opportunity to mentor engineers and shape best practices in medical device software.
- Why this job: Be at the forefront of life-changing medical tech in a fast-paced, collaborative environment.
- Qualifications: Experience in regulated medical device firmware development and compliance leadership.
The predicted salary is between 60000 - 80000 £ per year.
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.
Medical Firmware Staff Engineer employer: Cambridge Mechatronics Limited
Cambridge Mechatronics Ltd (CML) is an exceptional employer, offering a dynamic work environment in the heart of Cambridge, UK, where innovation thrives. With a strong focus on employee growth and development, CML provides opportunities to work on cutting-edge medical technology that has a real impact on people's lives. The collaborative culture encourages knowledge sharing and mentorship, ensuring that every team member can contribute to and learn from pioneering projects in the rapidly evolving field of medical devices.
Contact Details:
Cambridge Mechatronics Limited Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Medical Firmware Staff Engineer
✨Tip Number 1
Network like a pro! Reach out to folks in the medical device industry on LinkedIn or at local meetups. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for those interviews by brushing up on your technical skills and understanding the latest regulations in medical firmware. We recommend doing mock interviews with friends or using online platforms to get comfortable with the process.
✨Tip Number 3
Showcase your projects! If you've worked on any relevant firmware projects, make sure to highlight them during interviews. We love seeing real-world applications of your skills, especially in regulated environments.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always looking for passionate individuals to join our innovative team.
We think you need these skills to ace Medical Firmware Staff Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Medical Firmware Staff Engineer. Highlight your experience with regulated medical device firmware and any relevant projects you've worked on. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about medical technology and how your background makes you a perfect fit for our team. Don’t forget to mention your understanding of compliance and quality management systems.
Showcase Your Technical Skills:In your application, be sure to showcase your technical expertise in firmware development, especially in safety-critical environments. Mention specific standards like ISO 13485 and IEC 62304 that you’ve worked with, as this will resonate with us at CML.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. Plus, we love seeing candidates who take the initiative!
How to prepare for a job interview at Cambridge Mechatronics Limited
✨Know Your Firmware Inside Out
Make sure you brush up on your knowledge of embedded firmware, especially in regulated environments. Be ready to discuss specific projects where you've developed safety-critical firmware, particularly for medical devices like insulin pumps. This will show that you understand the unique challenges and requirements of the role.
✨Familiarise Yourself with Compliance Standards
Since this role involves working with ISO 13485 and IEC 62304, it’s crucial to demonstrate your understanding of these standards. Prepare examples of how you've implemented compliance in past projects, and be ready to discuss how you would ensure adherence to these regulations in your future work.
✨Showcase Your Leadership Skills
As a Senior/Staff Engineer, you'll need to lead and mentor others. Think of instances where you've guided teams through complex firmware development processes or improved practices. Highlight your ability to communicate effectively with cross-functional teams, as collaboration is key in this role.
✨Stay Updated on Industry Trends
The medical device field is constantly evolving, so it's important to stay informed about the latest regulations and technologies. Bring up recent developments in medical firmware or relevant standards during your interview to show your passion and commitment to continuous learning in this fast-paced environment.
