Essential Duties and Responsibilities:
Review, Author, Execute, perform, summarize, report out verification & validation test activities of components to 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.
Support compliance/ closure of Regulatory and Quality requirements before completing Design Outputs/ Program Deliverables.
Clear understanding of the elements of Risk Management, FMEA, critical / Essential parts identification, System reliability, Life / limits testing and related V&V tasks.
Participate in the development of Verification & Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices.
Participate in Lab area Setup for the division.
Lead qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection.
Diagnose, isolate and investigate problem reports. Drive product improvements and/or bug fixes.
Works with external test houses (such as EMI, EMC tests for electrical boards and full device) to define the test scope, author the test plans, test procedures, execute & consolidate the reports.
Ensure good documentation and Good Manufacturing practices are followed in the Verification and Validation Process.
Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives.
Deep knowledge in test automation tools and realizing test automation suite.
Experience in IEC basic safety, EMI-EMC standards.
Work closely with the auditees to understand the details and support with all relevant objective evidence.
Adheres to Baxter Quality Management system & supports quality audits.
Support on-going regulatory agency inspection readiness through the self-assessment program to include mock inspections and compliance with revised and emerging regulations.
Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Identify issues early to fix them. Refine the test plans and procedures through pre-verifications / Dry runs.
Interacts with design team to resolve tests-related technical issues.
Presents the findings / objective evidence and able to present with rationale with applicability / exclusions.
Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed.
What You’ll Bring:
Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
7 to 10 yrs of experience in Verification and validation testing of Software, hardware and System.
Relevant technical testing/reliability experience in electro-mechanical, electrical, or software testing.
An understanding of test methods and processes as well as the methods used to verify products in the realms of software, mechanical, electrical, functional and environmental testing environments.
Experience in - writing system, subsystem-level and module level verification and validation plans, procedures, Test Execution and Test report generation.
Understanding of hardware and software product design methodologies and test practices.
Familiarity with reliability theory and analysis as it pertains to test quantities derived from reliability.
Experience in medical device or similar product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation and Quality systems.
Deep domain knowledge in design verification and validation of medical devices is a plus.
Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.
Demonstrated experience in accomplishingobjectives. Able to deliver on multiple projects simultaneously.
Self-motivated with good interpersonal skills.
Good team player to achieve team goals and guide new joiners or junior team members.
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