Design Assurance Engineer

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.

Key Responsibilities:

1. Oversee design assurance activities to ensure compliance with regulatory and quality standards
2. Manage design control documentation, technical files, and risk management processes
3. Support design verification and validation activities, including test planning and analysis
4. Work closely with regulatory and quality teams to ensure successful product registration and compliance with ISO 13485 and other relevant standards
5. Assist in process validation and manufacturing transfer to ensure product quality and performance
6. Participate in internal and external audits, addressing corrective actions where necessary

The ideal candidate will have:

1. A degree in engineering, science, or a related technical field
2. Experience in medical device design assurance, quality engineering, or regulatory compliance
3. Strong knowledge of design control processes and documentation requirements
4. Familiarity with ISO 13485 and other relevant medical device regulations
5. Experience in risk management, verification and validation, and technical documentation
6. Strong analytical skills with the ability to interpret complex data and ensure compliance

If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!