Test and Verification Engineer

Medical Test Verification & Validation Engineer - Class III Medical Device

Key Responsibilities

Develop and execute verification and validation activities for a Class III medical device, producing verification protocols, validation plans and test reports in line with design control requirements.
Perform functional, integration, performance and reliability testing across hardware, embedded software and complete systems, ensuring full requirements traceability.
Investigate test failures, support root cause analysis and collaborate with hardware, software and systems engineers to resolve issues.
Generate objective evidence to support IEC 60601 compliance, ISO 14971 risk management and MDR/FDA regulatory submissions while contributing to continuous improvement of V&V processes.

Essential Skills

Proven Verification & Validation experience within a regulated medical device environment.
Strong understanding of Design Controls, requirements traceability and the medical device development lifecycle.
Experience testing embedded hardware and software systems, with hands-on use of laboratory equipment such as oscilloscopes, power supplies and data acquisition tools.
Knowledge of IEC 60601, ISO 13485 and ISO 14971, with excellent technical documentation and reporting skills.

Desirable Skills

Experience supporting MDR and/or FDA submissions.
Knowledge of automated test development using Python, LabVIEW or similar.
Experience with Hardware-in-the-Loop (HIL), EMC or environmental testing.
Familiarity with ALM tools such as Polarion, Jama or DOORS and manufacturing verification activities.

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