VandV Engineer

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
• Manage Change Control activities from Initiation to Implementation Phase.
• Ensure compliance with regulatory and quality requirements during change control activities.
• Design Control Activities
• Update and maintain Traceability Matrix, Design History File (DHF) Index, and other design control documentation.
• Support audits and inspections by ensuring documentation accuracy and completeness.
  
  

• Strong knowledge of V&V methodologies and medical device testing protocols.
• Proficiency in CAD Software such as Creo and SolidWorks.
• Proficiency in MS Office Suite (Word, Excel & PowerPoint).
• Proficiency in any PLM tools such as Teamcenter.
• Familiarity with ISO 13485 and medical device regulatory requirements.
• Excellent documentation, analytical, and problem-solving skills.
• Hands-on experience with mechanical testing equipment.
• Hands-on experience with Engineering Change Management/Change Control.