You are responsible for
Efficient V&V test strategy formulation for the System release
Member of the Problem Report Management Team as of Release for Verification and validation activities
Creating end to end V&V strategy, planning, estimation and WBS and responsible for execution till end
Defining end to end Test automation strategy, scope and approach
Conducting end to end Verification and Validation of the product(s) / product line(s)
Testability review of the user needs, intended uses and system requirements
The architecture of the test environment and test infrastructure
Defining the entry, suspension, and exit criteria for System Verification
Maintaining the System V&V Test Traceability Matrix (TTM)
System Verification Specifications quality and completeness
Assessing the Verification Baseline change impact and updating the System Verification Specification as appropriate
Gathering Risk Assessment test Verification Evidence
Complete design release V&V test evidence
Defect analysis post reporting and conducting reviews
Framing and execution of end to end automation strategy and approach
Regression testing, HALT or HAST
Pro-active contributions to V&V process and efficiency improvements.
Training the development and testing organization in testing discipline
Representing the testing organization in the architectural community
To succeed in this role, you should have the following skills and experience
Bachelor/Master degree in Electrical/ Electronic with 14+ 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 CT/AMI is preferred. Medical device testing knowledge is mandatory.
Knowledge of IEC 60601 standards and Knowhow of design control processes for medical device design
Understanding of healthcare regulatory procedures and conformities
Good application knowledge within project's scope and good understanding of development processes (software/HW/mechanical) in general
Hazard and norm compliance knowledge and has a testing and problem isolation skills
Knowledge of the test lifecycle and test function
Good team player and ability to work independently & act pro-actively
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
Has a thorough understanding of test techniques, domain expert and understands test tooling issues, can organize test automation, also able to do statistical analysis
--
You must verify your mobile number to apply to this job.