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    • Domain: Class III medical device · Validation and quality assurance.
    • Experience with system validation, testing or quality assurance in a medical device or…
    • Domain: Class III medical device · ISO 13485 · IEC 62304.
    • Working knowledge of ISO 13485, IEC 62304 and Class III medical device validation.
    • Familiarity with ISO 9001 quality management standards.
    • Proven experience in software quality assurance and testing methodologies.
    • Additional certifications in quality management or medical device compliance.
    • Experience with Class III medical device validation, testing or quality assurance.
    • Professional development in regulated medical device environments.
    • 2–5 years' experience in medical device validation, quality assurance or a related regulated…
    • Domain: Class III medical device · regulatory affairs.
    • 3–7 years' experience in regulatory affairs, quality assurance or related compliance roles within medical…
    • Potential to influence quality standards and testing approaches.
    • Professional development opportunities within a technical quality environment.
    • Familiarity with ISO 9001 standards and quality management principles.
    • Scope to develop expertise in automated testing and quality assurance practices.
    • System Validation Engineer opportunities in medical device development typically sit within quality-focused teams delivering Class III medical devices under ISO…
    • Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
    • Coach and mentor cross-functional colleagues to champion a proactive site-wide cGMP quality culture.
    • Working together in person supports close, real‑time…
    • Experience in system validation, testing or quality assurance within a medical device or regulated environment.
    • Strong analytical and problem-solving skills.
    • Domain: Class III medical device · validation and compliance.
    • Demonstrated experience with ISO 13485 and IEC 62304 in a medical device or comparable regulated…
    • Regulatory Specialists play a crucial role in ensuring that medical devices and related products meet stringent safety, quality and compliance standards.
    • Involvement in bringing innovative medical devices to patients.
    • 3–5 years of regulatory affairs experience within medical device development.

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Job Post Details

System Validation Engineer - job post

SThree
3.3 out of 5 stars
Leeds
£300 - £400 a day - Temp to perm, Full-time
You must create an Indeed account before continuing to the company website to apply

Job details

Pay

  • £300 - £400 a day

Job type

  • Temp to perm
  • Full-time

Location

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.

Disclaimer:
Please note that the content of this advert does not represent a live vacancy or any guarantee of future vacancies, and by responding to this advert you agree to us adding your details to our database for future opportunities.

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