Essential Duties and Responsibilities:
Formulate end to end system verification strategy for a product. Takes complete ownership of testing a product or release and ensures high quality deliverables.
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.
Author, execute, perform, summarize, report out verification & validation test activities of components of a full system device; which includes but not limited to: Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, 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 to ensure the requirements testability, design traceability & test coverage. Refine the test plans and procedures through pre-verification/dry runs.
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 Verification and Validation Process.
Leads the investigations by identifying the root cause and drive solutions.
Leads the regulatory responses and audits (internal and external) from the front. Adheres to Baxter Quality Management system & front ends the quality audits.
Participates in and contributes to the roadmap discussion.
Mentor peers/engineers in the stream of their expertise and on the processes.
Qualifications / Experience and/or Background
Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field.
12 to 15 years of experience in Verification and validation testing of Software, Hardware and System.
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 expertise in manual and automation testing. Well versed with software and system testing techniques.
Experience in writing system, subsystem-level and module level verification and validation plans, procedures, test execution and test report generation.
An understanding of test methods and processes as well as the methods used to verify product in the realms of software, mechanical, electrical, functional and environmental testing environments.
Familiarity with reliability theory and analysis.
Experience in technically leading a team of test engineers.
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