Design Assurance Engineer Job Saxmundham England UK,Engineering

Location: Saxmundham

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.

Key Responsibilities:

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

Participate in internal and external audits, addressing corrective actions where necessary

The ideal candidate will have:

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

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!

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance and Design

Industries

Medical Equipment Manufacturing

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