Job Description

Job Summary

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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.

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Key Responsibilities

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

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