Description
Engineer (5+ years of Experience)
Develop and execute verification strategies and test plans for MRI Scanner systems, ensuring alignment with regulatory requirements
Perform functional, performance, and safety testing of MRI Scanner components and subsystems, including hardware, software, and electromagnetic compatibility (EMC)
Collaborate with design engineers to identify and mitigate risks through design reviews, analysis, and testing
Document test procedures, results, and compliance evidence in accordance with regulatory guidelines and internal quality management systems.
Participate in regulatory submissions and audits, providing verification-related documentation and support as needed
Stay current with industry trends, best practices, and regulatory updates related to MRI Scanner technology and medical device verification
Should have experience in Qualiy assurance and Regulatory Audit aligned to medical devices Standard
Ensuring that products comply with government regulations, while quality assurance professionals are focused on delivering high-quality products to consumers
Detail-oriented approach to documentation and compliance, with a commitment to quality and regulatory excellence
Demonstrated experience working on Test Method development and test method validation
Experience in Quality assurance and regulatory Audit
Working knowledge of IEC 60601 standards is preferred
Skills & Experience
Assurance de la qualité (AQ), Dispositifs médicaux, Exigences réglementaires, Processus d'essai de logiciel, Réglementation gouvernementale, Travail d'équipe, Validation des méthodes d’essai, Vérification des dispositifs
Cyient is an Equal Opportunity Employer.
Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.
