At a Glance
- Tasks: Develop and execute testing for Class III medical devices, ensuring compliance and reliability.
- Company: Leading medical device company focused on innovation and quality.
- Benefits: Competitive hourly rate, hybrid work model, and opportunities for professional growth.
- Other info: Join a dynamic team with a focus on continuous improvement and cutting-edge technology.
- Why this job: Make a difference in healthcare by ensuring the safety and effectiveness of medical devices.
- Qualifications: Experience in verification and validation within regulated environments, strong technical skills required.
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.
Test and Verification Engineer in Sheffield employer: Vantage Consulting
Vantage Consulting is an exceptional employer, offering a dynamic work culture that values hands-on leadership and innovation in the manufacturing sector. Located in Hinckley, employees benefit from a collaborative environment that fosters professional growth and development, alongside competitive compensation and unique opportunities to influence operational success. Join us to be part of a team that prioritises accountability and communication, ensuring every voice is heard and valued.
We think you need these skills to ace Test and Verification Engineer in Sheffield
Verification and Validation
Design Controls
Requirements Traceability
Medical Device Development Lifecycle
Embedded Hardware Testing
Embedded Software Testing
Laboratory Equipment Proficiency
