Technical Documentation and Development Engineer

Job Description

A Technical Documentation & Development Engineer is required to support medical device product development through robust documentation, CAD formalisation, and regulatory compliance. The role focuses on ensuring all new and legacy products meet MDR requirements, with a strong emphasis on technical file ownership, structure, and accuracy.\n\nClient Details\n\nThis is an established healthcare manufacturer operating within a regulated medical device environment, focused on improving patient outcomes through product innovation and continuous improvement. The business has a growing portfolio of products and is investing in strengthening its documentation, compliance, and development processes.\n\nDescription\n\nKey responsibilities:\n\nProduce and maintain technical documentation in line with MDR requirements\nBuild, manage, and update Technical Files for both new and legacy products\nTake ownership of legacy documentation, including reverse engineering and generating CAD models/drawings\nCreate production-ready, revision-controlled CAD drawings from existing products and development inputs\nDocument all design changes, improvements, and development activities\nEnsure compliance with medical device regulations, standards, and internal gated processes\nSupport risk management activities and maintain structured design documentation (e.g.

DHF)\nCollaborate with cross-functional teams (R&D, Manufacturing, Regulatory, Supply Chain, Sales)\nSupport value engineering initiatives to improve cost efficiency without compromising quality\nCarry out engineering change requests (ECR), including drawing/specification updates\nProvide technical support to production teams and resolve engineering queriesProfile\n\nThe successful candidate:\n\nMinimum 5 years' experience in a technical engineering role within medical devices or a regulated environment\nStrong understanding of Medical Device Regulation (MDR) and compliance requirements\nProven experience managing Technical Files, DHF, and design documentation throughout the product lifecycle\nStrong CAD capability (SolidWorks or similar), with experience producing manufacturing-ready drawings\nExperience working within structured product development / gated processes\nHigh attention to detail with a methodical and organised approach\nStrong communication skills with the ability to work cross-functionally\nAnalytical, proactive, and capable of managing multiple documentation streams simultaneously\nHND (minimum) in Engineering, Product Design, or a related disciplineJob Offer\n\nWhat's on offer:\n\nSalary of £42,000\nOpportunity to play a key role in strengthening documentation and compliance within a growing medical device business\nExposure to both new product development and legacy product improvement projects\nCollaborative, cross-functional working environment\nLong-term career progression within a regulated healthcare manufacturing sector

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Job Overview

ID:

2458028

Date Posted:

Posted 21 hours ago

Expiration Date:

07/07/2026

Location:

Sheffield

Salary:

Competitive

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