insightec

Description

Define System Verification based on System (SW/HW) Design Inputs:

1. Study design/reliability requirements.
2. Take part in design reviews.
3. Define and execute feasibility experiments for proof of concept/design.

• Establish Verification Equipment, Verification Methods and Infrastructure:

1. Define, develop, and maintain testing equipment and methods to provide the means to execute verification.
2. Collect and analyze data for improvement of methods/processes.

• Plan and execute Design Verification and Process Validation for:

1. Developed products and processes.
2. Engineering Change Orders.
3. Service/Manufacturing equipment and processes.

• Prepare and release Verification Reports:

1. Based on collected, analyzed data vs. pre-defined acceptance criteria.
2. In compliance with company’s QMS and applicable standards/regulations.

• Participate in the following forums:

1. Design reviews
2. Product development gates and milestones.

• Initiate, manage, and monitor external testing contractors, such as Testing Houses and Labs.

1. Define and prepare testing to be performed by external contractors.
2. Identify and study relevant standards and guidelines (e.g. transportation/shelf-life standards).
3. Track, review and approve external testing reports.
4. Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

Requirements

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.

Advantages:

Experience with MRI/CT/Ultrasound or other imaging modality

Experience with external contractors

Experience in Medical Device industry