Design Quality Engineer

Cure Talent is working with an innovative medical technology company in Nottingham that is developing a complex hardware and software platform and progressing towards its release as a regulated medical device. As part of this transition, they are looking for a Design Quality Engineer to strengthen their design control processes, improve technical documentation and support the development of an ISO 13485-compliant design and development framework.

This is a hands-on position, combining ownership of design documentation with close collaboration across engineering, software and quality teams. What will you be doing? Taking ownership of Design History File (DHF) documentation, identifying gaps, improving existing records and maintaining appropriate design control processes. Developing and maintaining requirements traceability across hardware, software and system-level designs, linking user needs through to verification and validation evidence.

Managing risk documentation in accordance with ISO 14971, ensuring appropriate risk controls are implemented, documented and verified. Supporting usability engineering activities in line with IEC 62366, including use-related risk assessments and formative and summative evaluation documentation. Supporting design reviews, verification and validation activities, design transfer and preparation for regulatory submissions and audits. Working closely with engineering teams to improve technical documentation, strengthen design control practices and maintain a practical approach to compliance.

What are we looking for? Proven experience producing and maintaining design control documentation within a regulated medical device environment, particularly DHFs. Strong working knowledge of ISO 13485 design controls and ISO 14971 risk management requirements. Experience developing requirements, maintaining design traceability and supporting verification and validation activities. Familiarity with IEC 62366 usability engineering documentation and its relationship with risk management.

An engineering qualification or equivalent practical experience, with strong technical writing and documentation skills.

Experience with integrated hardware and software systems, IEC 60601 or medical device design transfer would be advantageous. You will have the opportunity to take meaningful ownership of design assurance activities within a specialist Med Tech business, helping establish the documentation and processes needed to bring an innovative technology into the regulated medical device market. Interested? Apply today or contact Cure Talent for a confidential discussion about the position.