Test and Verification Engineer

Medical Test Verification & Validation Engineer - Class III Medical Device

• Job Title: Medical Test Verification & Validation Engineer
• Duration: 6 months initially
• Location: Hybrid (3 days per week), Sheffield
• Outside IR35
• -5065 per hour

• 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.

• 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.

• 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.