Design Assurance Lead

Design Assurance /Quality Lead – Medical Devices

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• Greenfield Medical Device Development Programme
  
• Major New Product Introduction
  

This is an opportunity to join a medical device organisation at a truly pivotal stage in its growth. Having recently secured substantial funding, the company is now preparing to launch an innovative new product and is building out the core team that will take it from concept through to global commercialisation.

They are seeking an experienced Design Assurance / Design Quality Lead to take ownership of the design quality strategy for this next-generation medical device. It is a chance to build and shape quality frameworks from the ground up while working on a product that will have a real-world impact on patient outcomes.

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• Long-Term Opportunity with potential to transition into a permanent role
  
• Major New Product Introduction from concept through to global launch
  
• High-Impact Medical Device addressing real-world healthcare needs
  
• Collaborative, highly skilled team environment
  

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• Leading design assurance activities across the full product development lifecycle
  
• Owning Design Controls and ensuring compliance with medical device regulations and standards
  
• Establishing and developing SOPs, quality processes, and documentation frameworks from scratch
  
• Building and maintaining Design History Files (DHF) and Device Master Records (DMR)
  
• Driving traceability across requirements, risk management, verification and validation
  
• Supporting design reviews, risk management plans, and V&V activities
  
• Collaborating closely with regulatory teams to support global submissions
  
• Ensuring successful design transfer into manufacturing environments
  
• Acting as the quality representative across cross-functional program teams
  

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• 8–10 years’ hands‑on experience in medical device quality or design xcfaprz assurance
  
• Proven experience delivering New Product Introductions (NPI) from concept to commercialisation
  
• Strong knowledge of medical device quality systems and regulatory frameworks
  
• Hands‑on experience building processes, documentation, and quality frameworks – not just reviewing them
  
• Experience working with combination devices, wearable devices, or CGM technologies
  
• Expertise in design controls, risk management, and verification & validation processes
  
• A proactive mindset with the confidence to lead quality initiatives within a fast-moving product environment
  

Contact Declan Ferrao on or send your CV to