The candidate will be responsible for all aspects of testing, Verification & Validation processes of the company Medical Devices,
as well as taking active part in ensuring all medical devise Design
Controls are being met, from requirements specifications to product
commercialization.
Qualifications:
· Engineering academic
degree with SW background
· V&V hands on and management experience in the medical
device industry
· Experience with test
plans, test procedures, and test reports through the lifecycle of the product
· Working knowledge of the FDA Quality System Regulation,
ISO 13485, IEC 62304, and the EU Medical Device Regulation.
· Acquaintance with PCs,
networks, hardware and software products
· Capable of generating and
maintaining coherent design controls documentations