Design Control Lead - Haybury Limited : Job Details

Join a global leader in developing medical devices designed to improve the lives of patients. Their flagship product is a game-changer within their field.

With a strong commitment to innovation and patient care, they continuously conduct clinical studies to validate the effectiveness of their products.

They are seeking an expert within Design Control, to play a key role by leading and enhancing the Design Control, Useability Engineering and Risk Management activities within Product Development projects.

Key Responsibilities:

• Create and uphold Design Control from project inception through to regulatory approval, ensuring high standards in Design Control documentation, e.g. DHF
• Develop and implement Risk Management and Useability Engineering strategies, and the RM/UE plans
• Lead and coach project teams through Risk Management and Useability activities, whilst utilising Useability Agencies for simulation studies
• Collaborate cross-functionally with international project teams, supporting with design transfer to other departments, as well as for requirements management

The ideal candidate will have:

• Advanced degree in Engineering, Biotechnology, Pharmacy, MedTech etc.
• Proven experience within Design Control (ISO 13485 and 21CFR820.3) for Medical Devices
• Experience compiling the Design History File (DHF), including the files for Risk Management and Human Factors
• Good understanding of ISO 62366 and ISO 14971
• Strong communication skills, enjoys working as part of a multi-cultural team