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- Tasks: Ensure medical device designs meet quality and regulatory standards while managing documentation and risk processes.
- Company: Join a leading medical device manufacturer known for innovation and quality in health technology.
- Benefits: Enjoy a full-time role with opportunities for growth in a dynamic and supportive environment.
- Why this job: Be part of a team that shapes the future of healthcare through cutting-edge technology and compliance.
- Qualifications: Degree in engineering or science; experience in design assurance and knowledge of ISO 13485 required.
- Other info: Ideal for those passionate about making a difference in health technology.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent is delighted to be working with an innovative and well-established medical device manufacturer who is seeking a Design Assurance Engineer to support its growing product development team.
This is an exciting opportunity to contribute to the development and introduction of new medical devices, ensuring compliance with regulatory and quality standards.
Key Responsibilities:
- Oversee design assurance activities to ensure compliance with regulatory and quality standards
- Manage design control documentation, technical files, and risk management processes
- Support design verification and validation activities, including test planning and analysis
- Work closely with regulatory and quality teams to ensure successful product registration and compliance with ISO 13485 and other relevant standards
- Assist in process validation and manufacturing transfer to ensure product quality and performance
- Participate in internal and external audits, addressing corrective actions where necessary
The ideal candidate will have:
- A degree in engineering, science, or a related technical field
- Experience in medical device design assurance, quality engineering, or regulatory compliance
- Strong knowledge of design control processes and documentation requirements
- Familiarity with ISO 13485 and other relevant medical device regulations
- Experience in risk management, verification and validation, and technical documentation
- Strong analytical skills with the ability to interpret complex data and ensure compliance
If you\’re looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance and Design
Industries
Medical Equipment Manufacturing
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Design Assurance Engineer employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Assurance Engineer
✨Tip Number 1
Familiarise yourself with ISO 13485 and other relevant medical device regulations. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical device field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those involved in design assurance. Attend industry conferences or webinars to make connections and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific examples of your experience with design control documentation and risk management processes. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Research the company’s recent projects and innovations in medical devices. Showing that you are informed about their work can help you stand out during interviews and demonstrate your genuine interest in joining their team.
We think you need these skills to ace Design Assurance Engineer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and required qualifications for the Design Assurance Engineer position. Tailor your application to highlight relevant experience and skills.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in medical device design assurance, quality engineering, or regulatory compliance. Use specific examples to demonstrate your knowledge of ISO 13485 and design control processes.
Showcase Analytical Skills: Since strong analytical skills are crucial for this role, include instances where you successfully interpreted complex data or contributed to risk management and verification activities. This will help illustrate your capability to meet the job's demands.
Craft a Compelling Cover Letter: Write a tailored cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role and the company. Mention how your background aligns with their mission in health technology innovation.
How to prepare for a job interview at Cure Talent
✨Know Your Regulations
Familiarise yourself with ISO 13485 and other relevant medical device regulations. Be prepared to discuss how your experience aligns with these standards, as this will demonstrate your understanding of the compliance landscape.
✨Showcase Your Technical Skills
Be ready to talk about your experience with design control documentation and risk management processes. Highlight specific projects where you successfully managed these aspects, as it will show your practical knowledge in the field.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills, especially in design verification and validation activities. Think of examples where you faced challenges and how you overcame them, as this will illustrate your analytical abilities.
✨Engage with the Team
Since collaboration is key in this role, be prepared to discuss how you've worked with regulatory and quality teams in the past. Show enthusiasm for teamwork and how you can contribute to a positive working environment.
