Cure Talent is delighted to be working with an innovative and well-established medical device manufacturer who is seeking a Design Assurance Engineer to support its growing product development team.
This is an exciting opportunity to contribute to the development and introduction of new medical devices, ensuring compliance with regulatory and quality standards.
As their new Design Assurance Engineer, you will be responsible for managing design assurance activities, compiling technical documentation, conducting test analysis, and ensuring design control compliance. This role will involve working closely with quality, regulatory, and engineering teams to support successful product development and transfer into manufacturing.
Oversee design assurance activities to ensure compliance with regulatory and quality standards
Manage design control documentation, technical files, and risk management processes
Support design verification and validation activities, including test planning and analysis
Work closely with regulatory and quality teams to ensure successful product registration and compliance with ISO 13485 and other relevant standards
Assist in process validation and manufacturing transfer to ensure product quality and performance
A degree in engineering, science, or a related technical field
Experience in medical device design assurance, quality engineering, or regulatory compliance
Strong knowledge of design control processes and documentation requirements
Familiarity with ISO 13485 and other relevant medical device regulations
Experience in risk management, verification and validation, and technical documentation
Strong analytical skills with the ability to interpret complex data and ensure compliance