Test and Verification Engineer
Vantage Consulting
Remote-friendly
- Job Title: Medical Test Verification & Validation Engineer
- Duration: 6 months initially
- Location: Hybrid (3 days per week), Sheffield
- Outside IR35
- £50-£65 per hour
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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