You are responsible for
Requirement analysis
Testability review of the user needs, intended uses and system requirements
Preparing test scenarios
Preparing test cases for test levels - module/integration/system testing
Preparing test data and environment
Manage system baseline configuration and model control
Executing the test cases
Review product requirement specification and clearly understand each requirement in requirement specification documentation
Understand the analysis of hazardous impact of medical product to different personnel (patient, operator, etc...)
Develop test case per each requirement in requirement specification documentation
Schedule test case review meeting with relevant parties
Defect reporting
Verification and Validation of the product(s) / product line(s)
Analyze, interpret and report test results for both verification and validation testing
Performing regression testing, HALT or HAST
To succeed in this role, you should have the following skills and experience
Bachelor/master’s degree in electrical/ Mechanical/Electronics / Instrumentation / or Computer Science with 3 to 6 years of Medical Device Development / Testing experience
Extensive knowledge and experience on test discipline, test strategy, test authoring, reviews
Knowhow of design control processes for medical device design
Experience in X-ray, MRi, CT is preferred. Medical device testing knowledge is mandatory.
Good application knowledge within project's scope and good understanding of development processes (software/HW/mechanical/Electrical) in general
Hazard and norm compliance knowledge
Testing and problem isolation skills
Knowledge of the test lifecycle and test function
Good team player and ability to work independently & act pro-actively
Knowledge of IEC 60601 standards and Knowhow of design control processes for medical device design
Be structured and self-organized with good ability to communicate (both written and verbal) at different levels
Mindset to simplify and reach to solutions with speed
Working knowledge of Microsoft Project, Excel, Power Point, and Word required
Strong English written and verbal communication skills required
--
You must verify your mobile number to apply to this job.