EPM Scientific
Test Engineer
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Test Validation 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.
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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.
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