Design Assurance Engineer

We are looking for a Design Assurance/Design Control/Quality Engineer to join our team and work on major medical technology development projects, applying knowledge of standards and regulations to realise novel medical technologies for our clients around the world.

Requirements

• A degree in a scientific field or a related technical discipline
• A thorough knowledge and understanding of the requirements of medical device quality systems (e.g., MDR, ISO 13485 and FDA QSR)
• Appreciate working in multi-disciplinary device design teams, leading key development activities such as requirements writing and risk management to ISO 14971
• Experience of writing and reviewing design documentation for inclusion in Design History/Technical Files
• Excellent communication skills, allowing you to communicate with all levels with Cambridge Consultants and client organisations
• Working knowledge of Design Verification activities
• Ability to independently plan, organise and prioritise own time to achieve a high level of productivity

Benefits

• Competitive salary and benefits package