Design Assurance Engineer

The Design Assurance Engineer ensures project compliance to relevant regulations and to external and internal standards for design control activities and project documents. Your Key Responsibilities: Prepare medical device and drug/device combination product design and development documentation and compilation of Design History Files and/or Technical Files in collaboration with multi-disciplinary project teams. Interface with Quality Assurance functions to ensure compliance with company QMS and international standards and regulations. Guide and/or support project teams through design assurance and compliance activities and ensure best practices. Participate in and/or lead design reviews. Prepare medical device and drug/device combination product risk management documentation. What you’ll bring to the role: Masters, PhD, or university degree in the field of engineering, quality management, life sciences, or other relevant subject. Good working knowledge of medical device and drug-device combination product development processes including design verification. Proven track record (3+ years) as part of a medical device development team within a pharmaceutical, medical devices, and/or combination products setting. Experience working within the ISO13485 medical devices quality framework and in-depth knowledge of GMP, EU, and FDA regulatory requirements. Experience working with ISO14971 risk management for medical devices. Clear thinker, who can work independently and as part of a matrix team structure. Ability to take ownership of initiatives, deliver results and strive for continuous improvement. Results-orientated, enthusiastic, and driven by excellence. Excellent command of English (verbal and written). You’ll receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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