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À propos
Develop and maintain Design History File (DHF) documentation, including user needs and system requirements Participate in risk management activities and support usability engineering in accordance with medical device standards Collaborate with cross-functional teams to ensure product quality and regulatory compliance throughout the development lifecycle
Required qualifications
Bachelor's degree in Engineering or a related scientific discipline; Biomedical Engineering preferred Minimum of five years of experience in systems design or product development within a multidisciplinary organization Experience supporting Software as a Medical Device (SaMD) development and maintaining Design History File (DHF) documentation Working knowledge of ISO 14971 and familiarity with IEC 62304 and IEC 62366 Proficiency with requirements management and traceability tools such as Codebeamer or JIRA
Compétences linguistiques
- English
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