Software Test Engineer - Medical Devices (V&V)

KO2 is recruiting a Software Test Engineer (V&V) on behalf of a fast-growing medical device client based in Manchester, currently progressing a market ready device through FDA 510(k) approval. Following a recent increase in testing and documentation requirements, they need an experienced V&V engineer to take full ownership of test activity as the sole test resource on site., * Develop verification and validation test specifications from the device’s design history file, requirements and specifications

• Break high-level design/test requirements down into detailed sub-tests, test protocols and expected outcomes
• Execute and record verification/validation testing in line with relevant standards and processes
• Feed results back to the development team and support resolution of any non-conformances
• Design software test plans in compliance with IEC 62304 and FDA documentation standards
• Instrument and execute unit, module, integration and regression tests based on software design specifications
• Work closely with Quality and Regulatory colleagues to ensure testing supports the technical file

• Strong experience of V&V activities within an embedded software environment
• Embedded software development background using C/C++, sufficient to understand and define module level tests
• Experience converting requirements into structured test cases and procedures
• Experience working with medical devices running embedded software
• Working knowledge of IEC 62304 and ISO 13485
• Good understanding of the full software engineering lifecycle
• Scripting ability
• Able to work independently and self-manage a standalone testing function

Desirable

• Knowledge of IEC 60601 and/or ISO 14971