Software Test Engineer - Medical Devices

KO2 Embedded Recruitment Solutions Ltd; Manchester; On-site; GBP 47,047 - 78,412; Full time

Job summary

KO2 Embedded Recruitment Solutions Ltd supports a Manchester‑based medical device company in hiring a V&V engineer. The role is hands‑on and standalone, focusing on verification and validation of embedded software across device hardware.

Onsite in Manchester three days per week, you will own test activity from planning to execution, ensuring compliance with IEC 62304, FDA standards, and the full software lifecycle. Six‑month contract with a daily rate up to £425 outside IR35.

Qualifications

• V&V testing experience in embedded software environments
• C/C++ background to understand and define module-level tests
• Ability to convert requirements into structured test cases and procedures
• Experience with medical devices running embedded software
• Working knowledge of IEC 62304 and ISO 13485
• Strong understanding of the software engineering lifecycle
• Ability to work independently and manage a standalone testing function
• Desirable knowledge of IEC 60601 and/or ISO 14971

Responsibilities

• Develop verification and validation test specifications from design history file, requirements, and specifications
• Break high-level design and test requirements into detailed sub-tests, protocols, and outcomes
• Execute and record verification and validation testing per standards and processes
• Provide feedback to development and assist resolution of non-conformances
• Design software test plans in line with IEC 62304 and FDA documentation standards
• Execute unit, module, integration, and regression tests per design specifications
• Collaborate with Quality and Regulatory to support the technical file

Skills

V&V testing

C/C++ testing

Test case derivation

Medical device testing

IEC 62304 / ISO 13485

Software lifecycle

Independent testing

IEC 60601/ISO14971 desirable

Job description

Salary: £? - ? per year

Requirements

• Strong experience of verification and validation 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 function
• Knowledge of IEC 60601 and/or ISO 14971 is desirable

Responsibilities

• Develop verification and validation test specifications from the device's design history file, requirements, and specifications
• Break high‑level design and test requirements down into detailed sub‑tests, test protocols, and expected outcomes
• Execute and record verification and 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

Technologies

• Embedded
• Hardware
• Support

More

We are an innovative medical device company based in Manchester, progressing a market‑ready device through FDA 510(k) approval. This is a hands‑on, standalone contract role for 6 months initially, with potential to extend, and requires onsite presence in Manchester three days per week as the work involves direct interaction with device hardware. The rate is up to £425 per day, outside IR35. We are seeking an experienced V&V engineer to take full ownership of test activity as the sole test resource on site following an increase in testing and documentation requirements.