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System Verification Engineer

EPM Scientific
Leeds
4 months ago
Applications closed

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Clinical Research

Quality Partner

Lead System Verification Engineer

12-Month Contract

Location: West Midlands
As a Lead System Verification Engineer, you will be responsible for ensuring that complex systems meet their intended functionality and performance criteria, thereby contributing significantly to the overall quality and reliability of the medical device product.

Job Specification

Planning and Performing Verification

  • Develop and execute verification plans, protocols, and reports.

  • Ensure all system verification activities comply with regulatory standards (e.g., FDA, ISO 13485, IEC 62304).

  • Conduct risk analysis and ensure risk management activities are current and comprehensive.

Developing Test Procedures

  • Design and develop test cases and procedures based on system requirements and design specifications.

  • Implement automated testing where applicable to enhance efficiency and repeatability.

Analysing Data and Reporting Results

  • Analyse test data and report on verification outcomes.

  • Identify and document any defects or non-conformance, and collaborate with development teams to resolve issues.

Working Collaboratively

  • Work closely with cross-functional teams including design, firmware, and software engineers.

  • Provide technical guidance and mentorship to junior verification engineers.

  • Communicate verification progress and issues to stakeholders effectively.

Maintaining Documentation

  • Keep thorough records of all verification activities and results.

  • Ensure traceability of verification activities to requirements and risk management documentation.

Education

  • A Bachelor's or Master's degree in Engineering (Biomedical, Electrical, Mechanical, Software, or a related field).

Experience

  • 5-10 years of experience in system verification or a related field.

  • Familiarity with regulatory standards and guidelines relevant to medical devices.

Knowledge, Skills, and Abilities

  • Strong analytical and problem-solving skills.

  • Ability to troubleshoot software and hardware issues.

  • Proficiency in using verification and testing tools is a plus.

  • Excellent written and verbal communication skills.

  • Ability to work effectively in a collaborative team environment.

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