Software Test Engineer - Medical Devices

Manchester, Greater Manchester KO2 Embedded Recruitment Solutions LTD Role: Embedded Software Test Engineer - Medical Devices (V&V) Contract length: 6 months (initially) Location: Manchester - 3 days per week onsite Rate: Up to £425 per day, Outside IR35 We're recruiting a Software Test Engineer (V&V) for our client, an innovative medical device company based in Manchester currently progressing a market-ready device through FDA 510(k) approval. Following a recent scope 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. This is a hands-on, standalone role. You'll be working directly with the device hardware, so onsite presence three days a week is essential. This cannot be done remotely. Key Responsibilities 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 fileSkills & Experience required: 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 Able to work independently and self-manage a standalone testing functionDesirable Knowledge of IEC 60601 and/or ISO 14971Contract Details 6 month initial contract, with potential to extend 3 days per week onsite in Manchester Up to £425 per day, Outside IR35How to Apply If you have embedded software V&V experience within a regulated medical device environment and IEC 62304 / ISO 13485 knowledge, apply now or contact Chris Oddy to discuss further