* Study design/reliability requirements.
* Take part in design reviews.
* Define and execute feasibility experiments for proof of concept/design.
* Establish Verification Equipment, Verification Methods and Infrastructure:
* Define, develop, and maintain testing equipment and methods to provide the means to execute verification.
* Collect and analyze data for improvement of methods/processes.
* Plan and execute Design Verification and Process Validation for:
* Developed products and processes.
* Engineering Change Orders.
* Service/Manufacturing equipment and processes.
* Prepare and release Verification Reports:
* Based on collected, analyzed data vs. pre-defined acceptance criteria.
* In compliance with company’s QMS and applicable standards/regulations.
* Participate in the following forums:
* Design reviews
* Product development gates and milestones.
* Initiate, manage, and monitor external testing contractors, such as Testing Houses and Labs.
* Define and prepare testing to be performed by external contractors.
* Identify and study relevant standards and guidelines (e.g. transportation/shelf-life standards).
* Track, review and approve external testing reports.
* Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.
Advantages::
* Experience with MRI/CT/Ultrasound or other imaging modality
* Experience with external contractors
* Experience in Medical Device industry
* B.Sc. in: Electrical/Mechanical/Biomedical Engineering or Physics.
* At least 2 years of experience as System Testing/Verification Engineer in Medical Devices field or equivalent.
* Solid grasp of basic physical principles, SW/HW interfaces and familiarity with multi-disciplinary systems.
* Experienced with measuring tools, such as an oscilloscope, multimeters etc. and experiments design and execution, with focus on safety and statistical validity of results.
* Excellent English and documentation practices.
* Excellent working relations and Teamwork.
