We seek an experienced Lead Engineer to lead the software verification and validation activities which arepart of the overall software development process for medical diagnostics instruments.

Main responsibilities:

- Testing planning, coordination, and resource management
- Preparing test plans, reports, or estimates
- Designing, developing, and executing software tests to verify that the design meets the requirements documented
- Planning and implementing the configuration of the physical setup of equipment
- Reviewing the Test Cases document
- Selecting hardware and software tools and consumables to support testing, and ensuring that any requirements of tool training and validation are met
- Scheduling tasks for all members of the Test Team
- Tracking and reporting testing activities including testing results, test case coverage, required resources, discovered defects and their status, performance baselines, etc. as needed by the Project
- Implementing, monitoring, and enforcing all testing processes and procedures as per the standards defined by the organization
- Identifying the training requirements for the project, and forwarding them to the SETL
- Organizing and chairing the meetings of the Software Incident Review Board
- Improving the processes of testing based on the suggestions made by others and personal judgment
- Traveling to domestic and international locations

Requirements:

- A B.E, B.Tech, MCA, M.Tech, or M.Sc in Computer Science
- A minimum of 8 years’ experience in SW Verification and Validation
- Knowledge of how software verification or validation activities are integrated within a process of software development
- Ability to perform black-box, performance, stress and load testing as needed by the project
- Ability to design and develop software tests from the requirements of the software and specification documentation
- Ability to provide documented evidence of the test execution
- Participating inactivities of risk management including project, technical, and hazard
- Ability to comprehend documents of software specification
- Ability to peer-review the requirements of software and specification documents
- Ability to create manual tests for complex software modules from the requirements of software and specification documents
- Ability to define the estimate and track progress of tasks and communicate the status of projects
- Ability to create documentation of Requirements Trace
- Ability to perform reviews of manual tests and automated, if possible, tests
- Ability to determine the utilization of resource
- Strong skills in writing, presentation, and general communication
Possession of the following skills is a plus:
- Regulations of FDA Design Control, and the associated standards and guidance
- A Microsoft Team Foundation Server scripting
- Automated testing tools
- Medical device testing experience
- Experience working with an Agile or Scrum team
- A Testing certificateis desirable, such as ISTQB, CSTE, or any equivalent
- The fundamentals of database
- Communication protocols
- Network monitoring
- Monitoringof a Computer system performance
- Knowledge of various programming languages, such as C#, C +, C or Visual Basic
- Communication protocols, including LIS 3, HL7, POCT1A
- Calculated Parameters for reported analytes
- Statistical Data Analysis
- Experience in Project management
- excellent organizational and administrative skills