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.

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 queries

Profile

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 discipline

Job 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