Graduate Validation & Testing Engineer

Job Summary

This role will support the engineering department with component validation and testing, preparing technical protocols and reports, maintaining engineering documentation, and collaborating with cross-functional teams to ensure compliance with regulatory and quality requirements. This role sits within the Engineering Department and would suit a detail-oriented graduate or early-career engineer/scientist with a strong interest in medical devices, product validation, and quality systems.

Key Responsibilities

• Conduct component verification and validation testing to ensure compliance with quality, performance, and regulatory requirements.
• Perform physical, functional, and integrity testing of components and assemblies.
• Develop, execute, and document test protocols and validation activities.
• Support the development, verification, and continuous improvement of test methods.
• Review, document, and assess biological and physical characteristics of materials and components.
• Support validation and verification activities in accordance with applicable medical device regulatory requirements, including ISO 13485, ISO 14971, and relevant internal procedures.
• Ensure testing activities are conducted and documented in compliance with quality management system requirements.
• Analyse test data, identify trends, and prepare technical reports with conclusions and recommendations.
• Investigate test failures and support root cause analysis activities.
• Support component and material qualification activities, including supplier change assessments and material evaluations.
• Assist in the review of material specifications, certifications, and technical documentation.
• Participate in sample preparation and testing activities within controlled cleanroom environments.
• Collaborate with Engineering and Quality teams to facilitate routine product monitoring and testing.
• Support manufacturing and process engineering activities related to product development, validation, and continuous improvement initiatives.
• Adhere to cleanroom procedures, Good Manufacturing Practices (GMP), and safety requirements at all times.
• Participate in process improvement initiatives to enhance product quality, efficiency, and compliance.
• Assist with laboratory and testing activities as required.
• Create, maintain, and review material specifications.
• Support risk management activities, including risk assessments, hazard identification, risk analysis, and maintenance of risk management documentation in accordance with ISO 14971.
• Archive and maintain engineering records, including design change documentation, in accordance with company procedures.
• Support engineering change activities, including documentation updates, and implementation of approved changes.

Qualifications & Experience

• Tertiary qualification in Engineering or Science is highly desirable (or similar technical background).
• Excellent written communication skills with ability to prepare technical protocols, reports, and documentation.
• Strong analytical and problem‐solving abilities.
• Advanced proficiency in Microsoft Office applications, particularly Word, Excel, and PowerPoint.
• Ability to work independently while also collaborating effectively within multidisciplinary teams.
• Strong attention to detail and commitment to quality.
• Knowledge of medical device regulations and quality systems (ISO 13485, ISO 14971, GMP) is advantageous.
• Exposure to laboratory testing, materials testing, or validation activities through university projects or industry placements.
• Experience analysing data using Excel or statistical tools is desirable.
• Familiarity with technical drawings, engineering documentation, and change control processes is highly regarded.