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Responsible for the Test analysis, Test design ,Design of automation framework, Develop automation scripts, make design choices for new product development, sustenance activities, field issue resolution etc
Takes complete ownership of testing a product or release and ensures high quality deliverables. This covers both Manual testing & automation testing
Solid understanding and implementation of TDD & BDD
Proven experience in delivering medical devices to meet IEC/FDA/ISO standards and working closely with the regulatory bodies and affiliated labs
Develop automation strategy and framework for the Software and System level testing
Installation/Operational/Performance Qualification Protocols, Traceability Matrices and Final Reports
Pair up with design & development team to start the testing early in the design cycle (Sprints) to ensure the requirements testability, design traceability & test coverage
Identify and report any quality or compliance concerns and take immediate corrective/ preventive action as needed
Review work products and ensure the quality of deliverables
Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps
Lead the qualification of lab area, drive productivity improvement efforts, including testing, building fixtures, calibration, and data collection
Ensures good documentation and good manufacturing practices are followed in the Test Process
Leads the investigations by identifying the root cause and drive solutions
Mentor peers/engineers in the stream of their expertise and on the processes
Requirements
8-12 years of experience in Test / V&V Activities for a medical product
Bachelor's Degree in Software Engineering, Computer Science, Bio-Medical or related field
8-12 years of experience in testing of Software
Experience in design verification and validation of medical devices
and understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards
Deep hands on expertise in manual and automation testing using tools such as SQUISH, Java, Python
Experience in writing system, subsystem-level and module level verification and validation plans, procedures, test execution and test report generation
Familiarity with reliability theory and analysis
Experience in technically leading a team of test engineers
Excellent communication, inter-personal and leadership skills
Openness to collaborate in interest of project/organization
Proactive and self-driven, possesses due sense of urgency
Shall possess systems mindset and good problem-solving abilities
Working with multisite teams, Quality conscious and Process & customer Oriented