Job Description
We are seeking a highly skilled Senior Design Engineer to support and provide guidance for device development programs throughout the design and development lifecycle.
This role involves ensuring compliance with design control requirements outlined in Quality Management System, and relevant Regulations. The successful candidate will establish, maintain and provide guidance on the contents of Design History Files for development programs.
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Main Responsibilities
* Device Development and Manufacturing Operations Activities: Provide expertise in Device or Drug/Device Systems in a GMP Environment.
* Design Control Implementation: Ensure adherence to ISO/FDA Requirements.
* Risk Management: Implement ISO 14971:2019 guidelines.