Medical Device 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

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