Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Ensure accuracy and compliance of technical documentation for innovative cancer care products.
- Company: Join Endomag, a Hologic company, redefining cancer treatment.
- Benefits: Collaborative culture, personal growth opportunities, and meaningful work.
- Other info: Dynamic team environment with opportunities for continuous improvement.
- Why this job: Make a real impact in life-changing medical technology.
- Qualifications: Engineering or scientific background with strong documentation skills.
The predicted salary is between 40000 - 50000 £ per year.
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).
- Educational background in engineering or a scientific field (physics, biomedical, 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 or IVD 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.
Design Assurance Engineer employer: Hologic
Contact Detail:
Hologic Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Assurance Engineer
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their mission and values, especially how they relate to cancer care. This will help you tailor your answers and show that you're genuinely interested in making an impact.
✨Tip Number 3
Practice your responses to common interview questions, but keep it natural. Use the STAR method (Situation, Task, Action, Result) to structure your answers, especially when discussing your experience in design assurance and technical documentation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about joining our team at Endomag.
We think you need these skills to ace Design Assurance Engineer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Design Assurance Engineer role. Highlight your experience in creating technical documentation and any relevant engineering background. We want to see how your skills align with our mission at Endomag!
Showcase Your Attention to Detail: Since this role requires exceptional accuracy, don’t shy away from demonstrating your meticulous nature. Include examples of past projects where your attention to detail made a difference. We love seeing candidates who take pride in their work!
Highlight Collaboration Skills: As a Design Assurance Engineer, you’ll be working with various teams. Share experiences that showcase your ability to collaborate effectively with cross-functional teams. We value teamwork and want to know how you can contribute to our dynamic environment.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. We can’t wait to hear from you!
How to prepare for a job interview at Hologic
✨Know Your Stuff
Make sure you brush up on the technical aspects of design assurance and the specific regulations like ISO 13485 and FDA guidelines. Familiarise yourself with Endomag’s products and their impact on cancer care, as this will show your genuine interest in the role.
✨Showcase Your Collaboration Skills
Since the role involves working with various teams, prepare examples of how you've successfully collaborated in the past. Think about times when you acted as a liaison between different departments and how you ensured smooth communication and integration of inputs.
✨Attention to Detail is Key
Highlight your meticulous approach to documentation. Bring examples of technical documents you've created or edited, and be ready to discuss how you ensure accuracy and compliance. This will demonstrate your fit for the role's requirements.
✨Prepare for Regulatory Questions
Expect questions about regulatory compliance and audits. Brush up on your knowledge of CAPAs and how you've handled audits in previous roles. Being able to discuss these topics confidently will set you apart from other candidates.