Test Engineer

We're supporting an innovative medical technology company that is looking to hire a Test & Validation Engineer to lead verification and validation activities across a cutting-edge medical device platform.

This role will play a key part in supporting regulatory approvals, taking ownership of testing activities across hardware, software and cloud-based systems to ensure products meet performance, quality and regulatory requirements.

Responsibilities

• Develop and own the overall verification and validation strategy.
• Create test plans, protocols and detailed test cases.
• Execute verification and validation activities across hardware, software and integrated systems.
• Lead testing activities from planning through to completion.
• Identify and implement testing requirements to support FDA 510(k) submissions.
• Support regulatory approval activities and technical documentation.
• Perform functional, system and integration testing.
• Validate end-to-end platform performance across connected devices, software and cloud environments.
• Work closely with engineering and regulatory teams to ensure compliance and product readiness.

Requirements

• Proven experience within the medical device industry.
• Strong background in verification and validation (V&V) testing.
• Experience testing both hardware and software systems.
• Ability to develop testing strategies from product and system requirements.
• Experience writing and executing test plans, protocols and test cases.
• Demonstrated experience leading testing activities or owning a testing programme.
• Understanding of FDA 510(k) requirements and regulatory expectations.
• Ability to manage testing activities from concept through to regulatory submission.

Please apply or reach out for more information.