SThree
Validation Engineer
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Validation Engineers in medical device environments
Validation Engineers in medical device environments play a critical role in ensuring that regulated products meet stringent safety, quality, and compliance standards before they reach patients. This is an opportunity to register your interest in future Validation Engineer positions within Class III medical device manufacturing, roles that could support the delivery of compliant, life-saving technology.
Please note the content of this advert does not represent a live vacancy.
About The Opportunity
Roles of this type typically sit within quality assurance and regulatory teams at businesses manufacturing or developing Class III medical devices under ISO 13485 and IEC 62304 design controls. The work could involve designing and executing validation protocols, managing test documentation, liaising with engineering and quality functions, and ensuring that evidence of safety and efficacy is documented to FDA and regulatory standards. You could expect to contribute to cross-functional delivery in a structured, compliance-focused environment where accuracy and attention to detail directly impact patient safety.
Typical Role Overview
- Location: Manchester, Greater Manchester, England
- Type: Contract
- Full-time
- Rate: £300–400 per day
- Domain: Class III medical device validation and regulatory compliance
What You Would Do
- Designing and executing validation protocols for medical device processes, equipment, and systems
- Preparing and maintaining validation documentation, including protocols, reports, and traceability matrices
- Conducting design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities
- Managing test data, analyzing results, and preparing evidence packages for regulatory submissions
- Collaborating with engineering, quality, and manufacturing teams to resolve validation findings
- Supporting compliance with ISO 13485, IEC 62304, and FDA design control expectations
- Contributing to regulatory submissions and preparing for regulatory inspections
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What You Could Bring
Most roles of this type require the following:
- Bachelor's degree in Computer Science, Engineering, or a related technical discipline
- 2–5 years' experience in medical device validation, quality assurance, or a related regulated environment
- Working knowledge of ISO 13485, IEC 62304, and Class III medical device design controls
- Practical experience with validation protocols (DQ, IQ, OQ, PQ) or test documentation
- Proficiency in Microsoft Office, data analysis tools, and test management systems
- Strong written and verbal communication skills for cross-functional collaboration
- Authorization to work in the United Kingdom
Nice-to-have:
- GAMP 5 or equivalent validation framework knowledge
- Experience with risk management (ISO 14971) or quality management system audits
- Familiarity with electronic batch records (EBR) or laboratory information management systems (LIMS)
What Roles Of This Type Could Offer
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Most roles of this type offer the following, dependent on the industry and seniority of the role:
- Exposure to the full lifecycle of medical device validation and regulatory compliance
- Opportunity to develop expertise in ISO 13485 and IEC 62304 standards
- Contribution to products that directly support patient safety and clinical outcomes
- Collaborative, cross-functional working within a quality-focused culture
- Potential progression toward senior validation or quality management responsibilities, where supported by the role and performance
- Professional development in regulated medical device environments
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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