Skills Alliance is collaborating on an exclusive search with an innovative, fast-paced, global medical device company with a mission to save lives, by making every donated organ count.
They are a commercial stage organ technology company, committed to improving transplantation outcomes throughout the world.
The company's first product has been used to support more than 3,000 liver transplant operations globally.
As part of their ongoing expansion, they are seeking a motivated Software Quality Engineer to join the team.
Position Summary The role of 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 products.
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 a flexible, on-site role in their Oxford Facility to ensure effective control of the design and development, risk assessment, and change control, in collaboration with the R&D, Post-Market Engineering, and Quality teams.
Key Responsibilities Under direction from the Design Assurance Manager the Software Quality Engineer will: Assure software quality through the full lifecycle process in accordance with company software standards and procedures up to class C according to IEC 62304.
Complete relevant documentation and verification test reports for devices and systems, according to company documentation procedures.
Assist in design and risk review of new and existing medical devices.
Support and conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.
Contribute as part of the team to assist in other tasks as necessary.
Skills and Experience - Essential Good communication skills and written English.
Ability to work effectively in a multi-disciplinary team.
Proven track record of analytical problem-solving skills.
Experience in the quality assurance of software for medical devices or other risk compliant/regulated industries.
Familiar with complying with standard operating procedures, coding standards, quality management system, etc.
Working to strict timescales and being flexible to achieve.
C language knowledge.
An understanding of C coding guidelines, rules and directives, e.g., MISRA, and the ability to configure and operate static analysis tools, ideally Lint.
Exposure to the full software development lifecycle and the ability to review documents across the lifecycle for consistency and traceability.
Ability to identify risks in software requirements and implementations and assess the severity and probability of occurrence and mitigate risk.
Experience of reviewing applicable regulatory standards and ensuring that standard operating procedures remain compliant.
Experience of working in a waterfall software development lifecycle environment, participating in design reviews, and ensuring software lifecycle stage requirements are met.
Skills and Experience - Desirable Familiarity with the regulatory requirements for medical software for compliance with European and United States quality standards, with practical working knowledge of IEC 62304, ISO 13485, ISO 14971 and 21 CFR Part 11 quality systems.
Experience of automating software development practices, e.g., continuous integration/ delivery/ deployment and software tools to support, e.g.
Jenkins.
Knowledge of software quality metrics, e.g.
code coverage.
Software Development Tools, e.g., STM32CubeMx, IAR Embedded Workbench, WindRiver Work Bench, MPLAB X, mikroC PRO, Eclipse, Cantata.
Microsoft Office applications, ideally Office 365.
Qualifications A degree in software engineering, computer science, information engineering or other related scientific discipline.