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.
Client Details
This 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.
Description
Key responsibilities:
Produce and maintain technical documentation in line with MDR requirements
Build, manage, and update Technical Files for both new and legacy products
Take ownership of legacy documentation, including reverse engineering and generating CAD models/drawings
Create production-ready, revision-controlled CAD drawings from existing products and development inputs
Document all design changes, improvements, and development activities
Ensure compliance with medical device regulations, standards, and internal gated processes
Support risk management activities and maintain structured design documentation (e.g. DHF)
Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory, Supply Chain, Sales)
Support value engineering initiatives to improve cost efficiency without compromising quality
Carry out engineering change requests (ECR), including drawing/specification updates
Provide technical support to production teams and resolve engineering queriesProfile
The successful candidate:
Minimum 5 years' experience in a technical engineering role within medical devices or a regulated environment
Strong understanding of Medical Device Regulation (MDR) and compliance requirements
Proven experience managing Technical Files, DHF, and design documentation throughout the product lifecycle
Strong CAD capability (SolidWorks or similar), with experience producing manufacturing-ready drawings
Experience working within structured product development / gated processes
High attention to detail with a methodical and organised approach
Strong communication skills with the ability to work cross-functionally
Analytical, proactive, and capable of managing multiple documentation streams simultaneously
HND (minimum) in Engineering, Product Design, or a related disciplineJob Offer
What's on offer:
Salary of £42,000
Opportunity to play a key role in strengthening documentation and compliance within a growing medical device business
Exposure to both new product development and legacy product improvement projects
Collaborative, cross-functional working environment
Long-term career progression within a regulated healthcare manufacturing sector
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