לוח משרות דרושים מהנדסי מכונות ביקנעם עילית

we are seeking for a V&V Engineer, to join the QA, RA & CA department.
As a V&V Engineer, your principal task will be to verify and validate Medical Devices. You will be responsible for HW & System testing including test protocols and reports.
The main responsibilities within this role:
Design, develop and execute system Verification and Validation test procedures.
Responsible for writing detailed, comprehensive, and well-structured V&V test protocols and reports ensuring requirements coverage and traceability.
Analyzing issues and failures in the system.
Work in a highly multidisciplinary and complex technical environment and lead testing of cross-functional projects (with emphasis on mechanical and electro-optical aspects)
Being involved in the reliability and integration tests for prototypes under development
Coordination and management with external testing laboratories
Define and maintain the Verification & Validation plans.
Plan and arrange the work, schedules, and equipment required for testing and evaluating standard and special devices.
Identify, investigate, and document all findings raised during testing.
Work closely with cross functional team members including R&D (System, SW&HW), QA, RA and Product departments.

we aim to improve patient outcomes by empowering every gastroenterologist across the globe with artificial intelligence and disruptive therapeutic technologies.

In this exciting role as an Operation Quality Engineer, you will directly support the day-to-day Yokneam products manufacturing, transfer, and improvements activities. You will have the opportunity to drive a culture of continuous improvement by deploying sound engineering fundamentals to achieve quality objectives and ultimately yielding better patient outcomes.

A Day in the Life
Communicate quality standards and requirements within the organization and collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Oversee and participate change approval process (risk assessment, verification, validation).
Lead Quality Assurance and product quality improvements in cross-functional initiatives. Ensure that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
Collaborate with global Operations, QA, Engineering and Manufacturing to ensure quality standards are in place and support day-to-day manufacturing activities.
Specialize in the areas of production control, incoming material, product evaluation, and reliability, inventory control, and development as they apply to product or process quality.
Take an active role in leading and reviewing design and manufacturing changes and lead product quality investigations in support of CAPA, complaints and non-conforming material processes and lead Quality Assurance and product quality improvements in cross-functional initiatives.