System Validation Engineer
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Role details
Tech stack
Job description
System Validation Engineers in medical device settings could play a critical role in ensuring that Class III devices meet rigorous regulatory standards before reaching patients. This is an opportunity to register your interest in future System Validation Engineer positions within a regulated medical device environment, where roles could contribute directly to product quality and patient safety., Roles of this type may sit within a collaborative engineering environment focused on Class III medical device validation and compliance. The work could involve partnering with cross-functional teams to design, execute and document validation activities under ISO 13485 and IEC 62304, with scope to contribute to delivering devices that meet the highest regulatory standards., * Supporting the design and execution of system validation protocols and test cases
- Conducting validation testing and documenting results in compliance with IEC 62304 and ISO 13485
- Coordinating with engineering, quality and regulatory teams to ensure validation completeness
- Preparing validation reports and supporting regulatory submissions
- Contributing to traceability matrices linking requirements to validation activities
- Escalating validation findings and supporting corrective action processes, Most roles of this type offer the following, dependent on the industry and seniority of the role:
- Exposure to end-to-end system validation within a heavily regulated environment
- Opportunity to contribute to devices that support patient safety and clinical outcomes
- Potential for extension or permanent placement, subject to business requirements
- Collaborative working within a quality-focused engineering culture
- Professional development in medical device compliance and validation methodologies
Requirements
- Bachelor’s degree in Computer Science, Software Engineering or a related discipline
- Experience in system validation, testing or quality assurance within a medical device or regulated environment
- Working knowledge of ISO 13485, IEC 62304 and Class III medical device requirements
- Proficiency with test management tools and documentation systems
- Strong analytical and problem-solving skills
- Authorization to work in the United Kingdom
About the company
SThree is the global STEM workforce consultancy. We advise businesses, build expert teams and deliver project solutions to outpace tomorrow, together.
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