Senior Software Validation & Verification Engineer

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Our client is a fast growing international medical device company searching for an experienced Senior Software Verification & Validation engineer to ensure products maintain the highest levels of standards (SDLC) and compliance (IDVR). The Senior Software Verification & Validation Engineer will perform essential assessments of the state, quality and completeness of our and OEM's design history files. You will play a key role in building Verification and Validation processes; working on new and existing products particularly in the digital pathology arena and as always, exceeding customer's expectations. RoleProvide subject matter expertise in the following areas: IEC62304:2006 SDLC requirements; Software V&V requirementsEnsure industry best practices are integrated into software remediation activitiesPerform the necessary gap analysis of DHF items to satisfy the FDA's requirements for Guidance for Software, IEC62304:2015 and FDA Cybersecurity Safety for 510(k) regulatory submissionsCreate files for existing and OEM instrument's software including planning, architecture, design & testing, configuration management etc.Recognize necessary links to the Risk Management process compliant to ISO14971:2019 and creates supporting files where requiredCreate a strategy for our product portfolio and execute the plan, demonstrating state of the art and compliance of softwareReport validation metricsWork with the medical devices QMS 21 CFR 820.30 and ISO 13485:2016 requirementsSkills:Knowledge of IEC 62304:2006, GAMP5/CFR Part 11/Annex 11, ISO14971:2019, IEC62366-1:2015, FDA Guidance for Software Development, FDA Guidance for CybersecuritySoftware DHF assessments and remediation execution experienceRemediating legacy products for 62304 and IVDR/MDRProficiency with Software Development Life Cycle activitiesAbility to create and execute software validation elements and processesSoftware quality assurance experience specifically for medical devicesIdeally knowledge of Cloud Computing in GxP environmentFamiliarity with Atlassian products for tracking development of software and for testing e.g. TM4JExperience with assessing software portability, reliability, functionality and usabilityAdherence to a stage gated quality systemEducation:Ideally a degree in a Computer Science or equivalent medical device experience To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales