At a Glance
- Tasks: Ensure high-quality design documentation for innovative medical devices and coach the engineering team.
- Company: Cerca Magnetics, a pioneering tech company focused on brain imaging advancements.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Diverse and collaborative environment with a focus on continuous improvement.
- Why this job: Join a mission-driven team making a real impact in healthcare technology.
- Qualifications: Engineering degree or equivalent experience in regulated medical device documentation.
The predicted salary is between 40000 - 50000 £ per year.
Nottingham, UK. Founded in 2020, Cerca Magnetics Limited’s (Cerca) goal is to make a real difference to people’s lives through technological advances. Working in partnership with The University of Nottingham and Magnetic Shields Limited, we have commercialised the world’s most advanced wearable functional brain scanner. Our device measures the magnetic fields within the brain using Optically-Pumped Magnetometers (OPMs) and due to its lightweight design can be worn by both adults and children whilst allowing them to move during a scan. Following initial research-market sales, we are now progressing our technology toward release as a regulated medical device and building an ISO 13485-compliant design and development capability.
Description of the role:
As a Design Assurance Engineer, you will play a pivotal role in enabling our transition from research-focused product delivery to medical-device grade design controls. You will strengthen and improve the quality of our Design History File (DHF), risk management, and usability documentation across an integrated system with multiple subsystems. You’ll be hands-on authoring and improving documents, while coaching the engineering team so documentation becomes an enabler rather than a bottleneck.
Key role focus areas:
- DHF ownership & improvement: Own and maintain DHF content, lead DHF gap assessments/remediation, and improve templates/processes.
- Requirements & traceability: Improve and maintain system and subsystem design documentation (hardware and software), ensuring traceability throughout from user needs to V&V evidence. Participate in cross-functional design reviews to ensure documentation is audit-ready and technically sound.
- Risk management (ISO 14971): Drive and maintain risk management activities as designs evolve; ensure risk controls are implemented and verifiable; facilitate workshops/coaching where required.
- Usability documentation (IEC 62366 linkage): Ensure usability considerations are documented and linked to use-related risks and evidence, supporting the structure of formative/summative usability activities.
- V&V and design transfer support: Support verification planning/reporting and ensure evidence aligns to requirements and risk; contribute to manufacturing transfer documentation readiness.
- Audit/submission readiness: Support audit and submission preparation, working closely with Engineering/Quality and external regulatory support to close gaps efficiently.
- Team enablement: Coach and upskill engineers in high-quality DHF content, technical writing, risk documentation and best practices.
Required skills & experience:
- Engineering degree (e.g., BSc/HND in Medical Engineering) or equivalent experience.
- Demonstrable experience authoring, maintaining, and leading regulated medical device documentation, including DHF content, risk management records (ISO 14971) and usability documentation with minimal supervision.
- Working knowledge of ISO 13485 design controls and quality documentation practices; familiarity with ISO 9001.
- Strong written communication and attention to detail; able to balance compliance with a pragmatic engineering pace in a small company.
- Confident collaborative communicator able to work across design, software, technical and quality functions, and with various stakeholders.
Desirable (nice to have):
- Experience in magnetic shielding, sensing, or low noise environments.
- Background in biomedical device installation, especially neuroimaging.
- Familiarity with ISO documentation practices and standards (e.g., ISO 9001, ISO 13485, IEC 60601).
What you will bring to Cerca:
- Precision and reliability—ensuring every system performs to specifications before and after deployment.
- A collaborative and scientific mindset—balancing technical rigour with real-world usability.
- Commitment to continuous improvement, both in workflows and software tools.
- Passion for making advanced brain imaging technologies accessible and impactful.
In line with the Equality Act 2010, Cerca understand and appreciate the importance of equality, diversity and inclusion, both in work and in life. We therefore actively encourage applications from all backgrounds, as we believe a more diverse team is a more successful team! We look forward to hearing from you.
Design Assurance Engineer in Nottingham employer: Breath HR
Cerca Magnetics Limited is an exceptional employer located in Nottingham, UK, dedicated to making a meaningful impact through innovative technology. With a strong focus on employee growth and collaboration, we offer a supportive work culture that encourages continuous improvement and professional development. Our commitment to equality, diversity, and inclusion ensures that every team member's voice is valued, making it a rewarding place to contribute to groundbreaking advancements in medical devices.
