- The salary for this role is £42k.
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This is a full time, on-site position based in Sheffield.
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.
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
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
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
