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- Tasks: Manage design assurance activities and ensure compliance with quality standards.
- Company: Join a leading medical device manufacturer known for innovation and excellence.
- Benefits: Enjoy opportunities for growth, collaboration, and making a real impact in healthcare.
- Why this job: Be part of a dynamic team shaping the future of health technology.
- Qualifications: Degree in engineering or related field; experience in medical device design assurance preferred.
- Other info: Ideal for those passionate about quality and regulatory compliance in healthcare.
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.
As their new Design Assurance Engineer, you will be responsible for managing design assurance activities, compiling technical documentation, conducting test analysis, and ensuring design control compliance. This role will involve working closely with quality, regulatory, and engineering teams to support successful product development and transfer into manufacturing.
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
- 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!
Locations
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 and compliance, which is crucial for a Design Assurance Engineer.
✨Tip Number 2
Network with professionals in the medical device industry. Attend relevant conferences or webinars where you can meet people who work in design assurance or related fields. This can lead to valuable connections and insights that may help you land the job.
✨Tip Number 3
Prepare to discuss specific examples of your experience with design control processes and risk management. Be ready to explain how you've successfully managed documentation and compliance in past roles, as this will showcase your expertise and fit for the position.
✨Tip Number 4
Research the company’s recent projects and innovations in medical devices. Being knowledgeable about their products and challenges will allow you to tailor your conversation during interviews, showing that you're genuinely interested in contributing to their success.
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 qualifications required for the Design Assurance Engineer position. Tailor your application to highlight relevant experiences that align with these requirements.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in medical device design assurance, quality engineering, or regulatory compliance. Provide specific examples of projects where you managed design control documentation or conducted test analysis.
Showcase Technical Knowledge: Demonstrate your understanding of ISO 13485 and other relevant medical device regulations in your application. Mention any specific training or certifications you have that relate to design control processes and risk management.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role and the company. Explain why you are passionate about contributing to health technology innovation and how your skills can support their product development team.
How to prepare for a job interview at Cure Talent
✨Understand Regulatory Standards
Familiarise yourself with ISO 13485 and other relevant medical device regulations. Being able to discuss these standards confidently will show your commitment to compliance and quality assurance.
✨Showcase Your Technical Skills
Prepare to discuss your experience with design control processes, risk management, and technical documentation. Highlight specific projects where you successfully managed these aspects to demonstrate your expertise.
✨Collaborate Effectively
Emphasise your ability to work closely with cross-functional teams, such as regulatory and quality teams. Share examples of how you've facilitated collaboration in past roles to ensure successful product development.
✨Prepare for Scenario-Based Questions
Anticipate questions that may ask how you would handle specific challenges in design assurance. Think through scenarios involving design verification, validation, or audits, and be ready to articulate your approach.
