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    • Domain: Class III medical device · Validation and quality assurance.
    • Involvement in validating medical device systems that support patient safety and clinical…
    • Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
    • Domain: Class III medical device · system validation.
    • Professional development in medical device compliance and validation methodologies.
    • Professional development in regulated medical device environments.
    • Domain: Class III medical device · validation and regulatory compliance.
    • Domain: Class III medical device · ISO 13485 · IEC 62304.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device validation.
    • Previous experience in a medical device environment would be desirable.
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    • Domain: Class III medical device · validation and compliance.
    • Demonstrated experience with ISO 13485 and IEC 62304 in a medical device or comparable regulated…
    • Additional certifications in quality management or medical device compliance.
    • Experience with Class III medical device validation, testing or quality assurance.
    • System Validation Engineer opportunities in medical device development typically sit within quality-focused teams delivering Class III medical devices under ISO…
    • Ensure compliance with relevant medical device standards and regulatory requirements.
    • Knowledge of standards such as ISO 14971, IEC 62304, and related medical…
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System Validation Engineer
SThree
·
3.2
Leeds
£300 - £400 a day
Temp to perm, Full-time

Job details

£300 - £400 a day
Temp to perm, Full-time
Leeds

Full job description

System Validation Engineers play a critical role in ensuring that medical device systems meet rigorous regulatory standards and quality requirements before reaching the market. This is an opportunity to register your interest in future System Validation Engineer roles within Class III medical device environments, where your work could directly support the delivery of life-changing technology to patients.

Please note the content of this advert does not represent a live vacancy.

About the opportunity

Roles of this type may sit within a regulated, quality-driven engineering culture focused on Class III medical device validation and compliance. The work could involve partnering across engineering, quality and operations teams to demonstrate that systems meet ISO 13485, IEC 62304 and FDA design control requirements. You could contribute to validating complex medical device systems throughout their development lifecycle, helping to ensure that products reach patients safely and reliably.

Typical role overview

  • Location: Leeds, West Yorkshire, England
  • Type: Contract · Full-time
  • Rate: £300–400 per day
  • Domain: Class III medical device · Validation and quality assurance

What you would do

Typical responsibilities could include:

  • Conducting system validation testing to verify that medical device systems meet defined requirements and regulatory standards
  • Developing and executing validation protocols, test plans and test cases aligned to ISO 13485 and IEC 62304
  • Documenting validation activities, results and traceability matrices for regulatory submissions
  • Collaborating with engineering and quality teams to identify and resolve validation findings
  • Supporting compliance activities and regulatory reporting
  • Contributing to design control and verification activities throughout the product lifecycle

What you could bring

Most roles of this type require the following:

  • Bachelor's degree in Computer Science or a related engineering discipline
  • Experience with system validation, testing or quality assurance in a medical device or regulated manufacturing environment
  • Working knowledge of ISO 13485, IEC 62304 and Class III medical device standards
  • Familiarity with validation protocols, test case development and traceability documentation
  • Strong attention to detail and problem-solving capability
  • Authorization to work in the United Kingdom

Nice-to-have:

  • Experience with FDA design controls or premarket submission support
  • Knowledge of additional quality standards such as ISO 9001 or IEC 61508
  • Exposure to software validation or systems engineering methodologies

What roles of this type could offer

Most roles of this type offer the following, dependent on the industry and seniority of the role:

  • Involvement in validating medical device systems that support patient safety and clinical outcomes
  • Exposure to best-practice regulatory processes and quality standards within a professional engineering environment
  • Contract flexibility and competitive daily rates reflecting specialist expertise
  • Opportunity to build expertise in a growing and highly regulated sector
  • Potential for contract extension or future permanent opportunities, where supported by business requirements

About SThree

SThree is the global STEM workforce consultancy.
We advise businesses, build expert teams and deliver project solutions to outpace tomorrow, together.

Across the UK, we connect talented specialists with cutting-edge opportunities across technology, engineering, life sciences and financial services supported by our offices in London, Birmingham, Manchester, Glasgow and Leeds

How to register interest

If you are interested in being added to our database to be considered for future opportunities, registering is quick and easy. No cover letter required. We will be in touch when we are instructed on these roles to discuss the next step in your career.

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