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    • Ensure compliance with medical device regulations, standards, and internal gated processes.
    • Minimum 5 years' experience in a technical engineering role within…
    • Knowledge of regulatory requirements for Class I medical devices to MDD and MDR.
    • In this role, you will oversee all aspects of legislative compliance and…
    • Acting as a technical lead for your subsystem, balancing performance, quality, reuse and compliance within a regulated medical device environment.
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    • Experience in a regulated industry, preferably within medical devices or healthcare technology.
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    • In this role, you will be responsible for the electrical engineering aspects of product development and lifecycle support, conducting prototype and development…
    • As a Design Assurance Engineer, you will play a pivotal role in enabling our transition from research-focused product delivery to medical-device grade design…
    • Experience in medical device design or other highly regulated industries is desirable.
    • You will play a key role in new product introduction (NPI), working cross…
    • Understand the business objectives, project scope, schedule, and critical success factors.
    • Understand and engage all project stakeholders relevant to the SME…
    • They will also work with design engineers and participate in product focus groups to gain critical customer application and design suggestions which assist in…
    • Carrying out supplier technology benchmarking to support product development.
    • Exposure to cutting-edge technologies and product development.
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Job Post Details

Technical Documentation and Development Engineer - job post

Michael Page
3.7 out of 5 stars
Sheffield
£42,000 a year - Permanent
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Job details

Pay

  • £42,000 a year

Job type

  • Permanent

Location

Sheffield

Full job description

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

About Our Client

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.

Job 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

The Successful Applicant

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

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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