OrganOx
Healthcare
SoftwareQualityEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Software Quality Engineer at OrganOx. Skills: Software quality assurance, Medical device software, Regulatory compliance. Assure software quality. Complete documentation”
Industry & Context.
Analytical problem-solving
What They're Looking For.
Must Have
Degree in software engineering, Degree in computer science, Degree in information engineering, Experience in software QA for medical devices, Experience in QA for risk compliant industries, Experience reviewing regulatory standards, Experience working in waterfall lifecycle, Experience participating in design reviews, Experience ensuring lifecycle stage requirements met, Microsoft Office applications experience, C language knowledge, Understanding of C coding guidelines, Ability to configure static analysis tools, Ability to operate static analysis tools, Exposure to full software development lifecycle, Ability to review documents for consistency, Ability to review documents for traceability, Ability to identify risks in software requirements, Ability to identify risks in software implementations, Ability to assess severity of risk, Ability to assess probability of risk, Ability to mitigate risk, Proven track record analytical problem-solving skills, Working to strict timescales, Flexibility to achieve
Nice to Have
Familiarity with IEC 62304, Familiarity with ISO 13485, Familiarity with ISO 14971, Familiarity with 21 CFR Part 11, Practical working knowledge of quality systems, Knowledge of software quality metrics, Experience of automating software development practices, Experience with continuous integration, Experience with continuous delivery, Experience with continuous deployment, Experience with Jenkins, Experience with STM32CubeMx, Experience with IAR Embedded Workbench, Experience with WindRiver Work Bench, Experience with MPLAB X, Experience with mikroC PRO, Experience with Eclipse, Experience with Cantata, Experience with Lint, Experience with Office 365
What You'll Do.
Assure software quality
Complete documentation
Complete verification test reports
Assist in design review
Assist in risk review
Support risk assessments
Conduct risk assessments
Support failure mode analysis
Conduct failure mode analysis
Contribute to other tasks
Adhere to Code of Conduct
Adhere to company policies
How You'll Work.
Team & Collaboration
Multi-disciplinary team; R&D teams; Post-Market Engineering; Quality teams
Communication Scope
Written English
Process & Methodology
Waterfall software development
Full Job Description
**ABOUT ORGANOX:** OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. **Position Summary** The Software Quality Engineer is responsible for supporting software quality assurance by ensuring regulatory compliant software life cycle documentation is produced, confirming adherence to software procedures and coding standards, and participating in software testing. The Software Quality Engineer will be involved in the software quality assurance of the full software development lifecycle of new and existing product. As a medical device company, software documentation and procedures must adhere to the relevant standards under the guidance of the Director of Regulatory Affairs. The Software Quality Engineer will join rapidly growing Quality team and will have a proven track record in software quality assurance. The Software Quality Engineer will report to the Design Assurance Manager. This is an on-site role in Oxford, with flexibility, to ensure effective control of the design and development, risk assessment, and ch
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