Design Assurance Engineer Cambridge, Cambridgeshire, United Kingdom Design Assurance Engineer Role location : Cambridge, UK Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by shaping the future of cancer care. At Endomag, a Hologic company, we're redefining cancer treatment and empowering clinicians worldwide with innovative medical solutions. We're now looking for a Design Assurance Engineer to join our dynamic Implantables Engineering team in Cambridge. As a Design Assurance Engineer you will play a pivotal role in ensuring the accuracy, consistency and compliance of technical documentation for our products. You will collaborate with multi-disciplinary engineers, clinical trial managers, regulatory affairs specialists and quality assurance experts to create and maintain audit-ready documentation. Your efforts will directly support to deliver innovative, high-quality medical technologies that transform cancer care and improve patient outcomes worldwide. KEY RESPONSIBILITIES Oversee the creation and maintenance of technical documentation for Endomag's products, including user needs, design inputs, design outputs, verification and validation testing plans and reports, test reports, technical files and design history files, engineering drawings and manufacturing specifications Lead Cross-Functional Collaboration: act as the primary liaison between R&D, Regulatory Affairs, Clinical Affairs, Product Engineering and Quality Assurance, ensuring seamless integration of their inputs into the technical documentation Champion Good Documentation Practices: adopt a meticulous approach to creating and editing content, driving efforts to improve documentation practices and ensure consistency and audit readiness Support Regulatory Compliance: review technical documents to ensure compliance with Endomag's Quality Management System, FDA, MDR regulations, and applicable international standards (e.g., ISO 13485, ISO 14971) Participate in Regulatory Submissions and Audits: facilitate reviews by internal and external auditors, interact with regulatory agencies as needed, and lead efforts to implement Corrective and Preventive Actions (CAPAs) KNOWLEDGE, SKILLS & EXPERIENCE Educational background in engineering or a scientific field (mechanical engineering preferred) Experience in creating and editing technical reports and documentation Exceptional attention to detail and high levels of accuracy Demonstrated ability to take ownership of initiatives, deliver results and drive continuous improvement Excellent content creation and editing skills Excellent written and verbal communication skills, with the ability to communicate effectively with cross-functional teams and regulatory agencies. Good organizational and time management skills to handle conflicting priorities and meet tight deadlines Experience in design assurance, quality or technical documentation roles in the medical device industry is highly desirable Ready to Make an Impact? If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you! Innovate with Purpose: Work at the forefront of life-changing medical technology. Collaborative Culture: Join a friendly, supportive team where your contributions matter. Personal Growth: Expand your skills in a fast-growing, global company. \LI-KP1 \associate