Contract System Requirements Engineer

Title: Contract System Requirements Engineer
Location: Fully Remote, occasional travel to London
Duration: 6 months (immediate start)

Rate: £350-£450 per day
IR35: Small Company Exemption

Contract System Requirements Engineer is required on a 6-month contract to write and validate requirements documentation and create design artefacts for a groundbreaking medical device. The successful candidate will have industry experience with medical devices or similar safety or mission critical systems that are highly regulated environments.

Key Experience

• 3+ years relevant experience in requirements
• Medical device experience desirable. Experience in safety or mission critical systems will be considered
• Working with complex systems and non-trivial design
• Experience in regulated environments, ideally with FDA regulated products but not essential.
• Strong experience working with and without document management, change management, risk management, and quality management systems.
• Drive refinement and translation of user requirements (clinical, serviceability, reliability, and manufacturability), regulatory requirements, and system architecture and concepts into functional requirements.
• Manage requirements to be compliant with requirement policies and ensure coverage, quality, and full implementation of requirements.
• Have good collaboration skills with stakeholders and the ability to work independently

Desirable Experience

• Medical device experience with IVDD/IVDR standards
• Clinical and/or biomedical technology experience
• ISO standards compliance experience
• GDPR & HIPPA awareness
• AI and machine learning best practice documentation
• Strong risk management skill

The successful candidate will be joining a team that have been working towards bringing a new medical device product to market. The timing is pivotal as the finer design decisions and market engagement strategy are being finalised.

If you are suitable and interested in this opportunity, then please apply or send your CV directly to

Spectrum IT Recruitment (South) Limited is acting as an Employment Business in relation to this vacancy.