Senior Design Assurance Engineer

Shape the Future of Medical Device InnovationWe''re seeking a talented and detail-oriented Design Assurance Engineer to join an innovative Medical Device organisation based in Cambridge.This is an exciting opportunity to play a pivotal role in the development of next-generation drug delivery devices and combination products, ensuring products are designed and developed in compliance with global regulatory requirements, industry standards, and quality expectations.Working alongside multidisciplinary engineering, quality, and regulatory teams, you will provide design assurance expertise throughout the product development lifecycle, helping bring safe, effective, and compliant products to market.The RoleAs a Senior Design Assurance Engineer, you will be responsible for supporting product development activities while ensuring compliance with medical device regulations, design control requirements, and risk management processes.Key ResponsibilitiesDesign Assurance and Product DevelopmentSupport and review design control activities throughout the product development lifecycle.Participate in risk management activities in accordance with ISO 14971.Review engineering changes, impact assessments, and design modifications.Ensure Design History Files (DHFs) are maintained to a high standard.Support stage-gate reviews and provide design assurance oversight across projects.Contribute to design decisions through technical analysis and risk-based evaluation.Quality and Regulatory ..... full job details .....