As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.
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
Validation, Verification & Testing
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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.
Sample Preparation & Cross-Functional Collaboration
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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.
Documentation & Quality Support
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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.
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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Strong 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.
Preferred Skills
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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.
