Design Assurance Engineer - #2636769

We are seeking a Senior Design Assurance Engineer to support an expanding portfolio of medical devices as the organisation transitions from development to commercial scale. This role is central to ensuring product quality, regulatory compliance, and efficient design-to-manufacture transfer. You will work in a fast-paced environment, take ownership of key projects, and contribute directly to the development of life-changing healthcare products.

Key Responsibilities

• Support and lead design verification and validation activities
• Contribute to design controls, design reviews, and design change processes
• Support regulatory documentation and submissions
• Develop and improve test methods, work instructions, and validation protocols
• Support human factors and usability studies
• Drive corrective and preventive actions and root cause investigations
• Support design transfer from development to manufacturing

Experience & Qualifications

• Degree (Level 8 or equivalent) in Engineering, Science, or related discipline
• 3+ years’ relevant engineering experience
• Experience working within an ISO 13485 or similar regulated environment
• Strong knowledge of design controls, FMEA, and medical device quality systems
• Familiarity with FDA and ISO regulatory requirements
• Experience producing technical documentation and analysing data

Please attach a copy of your CV.