Senior Hardware Validation Specialist

1 week ago

Bengaluru, Karnataka, India beBeeMechanicalEngineer Full time ₹ 20,00,000 - ₹ 25,00,000
Job Overview

The Mechanical Test Engineer role requires an individual with proven expertise in testing medical products that combine both hardware and software. This person will work collaboratively with other members of the V&V team and other teams to ensure that the hardware subsystem and system are thoroughly verified and documented according to quality management principles.

Main Responsibilities

  • Develop, execute, and report out verification & validation test activities of components to a full system device: Including but not limited to:
  • Test Plans, Test Procedures, User and Functional Requirements testing,
  • Design Verification,
  • Installation/Operational/Performance Qualification Protocols,
  • Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables.
  • Support the qualification of lab area, productivity improvement efforts, including testing, building fixtures, calibration and data collection.
  • Detect, isolate and investigate problem reports. Drive product enhancements.
  • Collaborate with external test houses 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 enhancement initiatives
  • Participate in V&V development process improvement and test automation.
  • Maintain awareness of current regulatory trends and their impact on the Verification and validation status of equipment and processes.
  • Support SMEs on Regulatory responses and Audits as needed.
  • Adhere to client's Quality Management system & support quality audits.
  • Presents 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.

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