MedTech Design Quality Engineer: DHF, ISO 13485 & Risk

Cure Talent Ltd; Nottingham; On-site; GBP 50,000 - 70,000; Full time

Job summary

Cure Talent Ltd in Nottingham is partnering with an innovative medical technology company to strengthen its design quality framework. This hands-on role owns Design History File documentation and drives design control across hardware and software teams.

You will collaborate with engineering, software and quality groups to advance ISO 13485 design controls, ISO 14971 risk management, and usability engineering per IEC 62366, aiding regulatory submissions and audits.

Qualifications

• Proven experience producing and maintaining design control documentation in regulated medical devices (DHF).
• Strong knowledge of ISO 13485 design controls and ISO 14971 risk management.
• Experience developing requirements, maintaining traceability, and supporting verification and validation.
• Familiarity with IEC 62366 usability engineering and its relation to risk management.
• Engineering qualification or equivalent with strong technical writing and documentation skills.

Responsibilities

• Taking ownership of Design History File (DHF) documentation, identifying gaps and improving records.
• Developing and maintaining requirements traceability across hardware, software and system designs.
• Managing risk documentation per ISO 14971 with appropriate risk controls.
• Supporting usability engineering activities per IEC 62366 including use-related risk assessments and evaluation documentation.
• Supporting design reviews, verification and validation activities, design transfer and regulatory submissions/audits.
• Collaborating with engineering teams to improve documentation and strengthen design control practices.

Skills

Design controls

Risk management

Technical writing

Systems thinking

Education

Engineering degree

Tools

Document control software

Job description

Cure Talent Ltd in Nottingham is partnering with an innovative medical technology company to strengthen its design quality framework. This hands-on role owns Design History File documentation and drives design control across hardware and software teams.

You will collaborate with engineering, software and quality groups to advance ISO 13485 design controls, ISO 14971 risk management, and usability engineering per IEC 62366, aiding regulatory submissions and audits.