Job Description

Job Requirements

Role Purpose

Support New Product Development (NPD) and lifecycle management of medical devices by performing Verification & Validation (V&V) activities, Design Control, and Change Management in compliance with ISO 13485 and client-specific quality standards.

Key Responsibilities

  • New Product Development Support
  • Collaborate with NPD teams to validate prototypes and ensure manufacturability.
  • Use CAD Software like CREO or SolidWorks for the design and development of test fixtures.
  • Verification Testing
  • Create Test Protocol and Final Report for Function testing.
  • Test method validation.
  • Conduct Verification testing activities for medical device components in accordance with internal study protocols.
  • Utilize standard laboratory equipment and measurement tools to perform functional tests on medical disposable components.
  • Change Control Management
  • ...

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