Design Assurance Engineer

Breath HR; Nottingham; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

Based in Nottingham, Cerca Magnetics Limited is seeking a Design Assurance Engineer to drive medical-device grade design controls as we transition from research to regulated manufacturing. You will strengthen the Design History File, risk management, and usability documentation across an integrated system, authoring and coaching the team toward audit-ready quality.

You will own DHF content, improve traceability from user needs to V&V, support verification planning and release readiness, and

Qualifications

• Engineering degree or equivalent, with regulated medical device documentation experience.
• Experience authoring and leading DHF content, ISO14971 risk management, and usability documentation with minimal supervision.
• Knowledge of ISO 13485 design controls and ISO 9001.
• Strong written communication and attention to detail; balance compliance with a pragmatic engineering pace in a small company.
• Collaborative communicator across design, software, and quality functions.

Responsibilities

• Own and maintain DHF content, lead gap assessments and remediation.
• Improve system and subsystem design docs with traceability from user needs to V&V.
• Lead risk management activities per ISO 14971 and coach teams.
• Document usability considerations linked to use-related risks.
• Support verification planning, reporting and evidence alignment to requirements and risk.
• Assist audit and submission readiness with regulatory support.
• Coach engineers in high-quality DHF content and technical writing.

Skills

Written communication

Attention to detail

Cross-functional collaboration

Coaching engineers

Education

Engineering degree (BSc/HND) or equivalent

Job description

Nottingham, UK

Details

About Us:

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.