Senior Design Assurance Engineer
SRG · Cambridge, England ·
Shape the Future of Medical Device Innovation We'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 Role As 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 Responsibilities Design Assurance & Product Development Support 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 & Regulatory Compliance Ensure compliance with internal Quality Management Systems and regulatory requirements. Support internal, customer, and external audits, including ISO 13485 audits.
Collaborate with Quality and Regulatory teams on technical documentation and submissions. Maintain awareness of evolving regulatory requirements and industry best practice. Verification, Validation & Risk Management Support design verification and validation activities.
Review verification evidence to ensure alignment with product requirements and risk controls. Support test method validation and usability engineering activities. Assist project teams in identifying and addressing compliance gaps.
Participate in risk-benefit analyses and residual risk assessments. Documentation & Continuous Improvement Maintain traceability between user needs, design inputs, risk controls, verification activities, and design outputs. Ensure documen...