At a Glance
- Tasks: Lead quality engineering for innovative medical devices and ensure compliance with industry standards.
- Company: Join a forward-thinking company dedicated to improving healthcare solutions.
- Benefits: Enjoy flexible working, private healthcare, and generous annual leave.
- Other info: Collaborative culture with opportunities for professional growth and team activities.
- Why this job: Make a real difference in healthcare while advancing your career in a supportive environment.
- Qualifications: Senior-level experience in quality engineering within medical devices or pharmaceuticals.
The predicted salary is between 51000 - 73954 £ per year.
We are currently seeking an experienced Senior Design Quality Engineer to join our talented team and contribute to delivering exceptional solutions for our clients.
Responsibilities
- You will partner with electromechanical and software engineering and design teams to deliver new products to market in compliance with required quality requirements and processes.
- You will guide project teams through consistent, compliant and lean delivery according to Design Control and Risk Management processes.
- You will provide clear updates to stakeholders across the business and give guidance on project readiness.
- You will develop, maintain complete and compliant Design History Files and support the development of regulatory submissions for new products including pre‑submissions, 510(k) and other product required regulatory submissions.
- You will interface with external regulatory experts and clients to drive collaborative delivery of Design History Files.
- You will support the continual improvement of Quality System processes and tools that support the product development process.
- You will provide coaching and training to other teams relating to Design Control processes and continuous improvement.
- You will support our quality and delivery teams with carrying out QMS and project audits when required, including participation as a subject‑matter expert when needed.
About you
You will be working already at a senior level either in Consultancy, or industry, or at a start‑up within the medical device and medicinal products sector. You will be comfortable taking the lead in large project teams in complex medical device development, ready to collaborate with Software, Electronic and Mechanical Engineers, Designers, and Manufacturing experts.
Skills and experience
- Either a degree in a relevant engineering, design or science discipline (or equivalent qualification – advanced degree preferred), or equivalent work experience.
- Demonstrable experience of progressive quality and hands‑on experience in a regulated environment, supporting medical devices or pharmaceuticals operations (generally 5–8 years of experience).
- Experience guiding teams through compliant development of medical software and complex electromechanical systems.
- Experience in interfacing with multiple internal and external stakeholders and driving high quality work to meet their needs.
- Experience contributing to the development of Quality Management Systems and the ability to interpret regulations.
- Experience ensuring a high level of compliance with MDR, ISO 13485, 21 CFR 820, and cGMP.
- Experience with Risk Management tools and techniques (ISO 14971).
- Experience in IEC 62304 and IEC 60601 would be desirable.
- Experience in auditing to ISO 13485 would be desirable.
- Able to review and understand hardware, firmware and software requirements and specifications.
- Excellent communication and interpersonal skills.
- Excellent presentation skills, including written and verbal communication skills.
Salary
The salary for this role is in line with our Senior band, from £51,000 up to £73,954. Please note we ask you to provide your expected salary within the band as part of your application, this helps us understand how you view your experience against the role's scope.
Benefits
- Performance‑related company‑wide bonus.
- Flexible hybrid working in line with our core hours (Mon‑Thu, 9:30 am‑12:00 pm & 2:00 pm‑4:00 pm; Fri, 9:30 am‑12:00 pm).
- Private healthcare for you and your family.
- Enhanced maternity and paternity leave.
- Salary‑exchange pension scheme.
- 25 days of annual leave, plus the option to purchase up to one working week and additional days for length of service.
- Access to our Employee Assistance Programme and digital wellbeing platform.
- Cycle‑to‑Work & Electric Vehicle Lease schemes.
- Death in service (x4 gross salary).
- Training and development opportunities, including dedicated learning days and regular knowledge‑sharing sessions.
- A free lunch on the first Monday of every month alongside our company‑wide meeting.
- Free breakfast every Wednesday, and plenty of opportunities to socialise, including team‑organised activities, summer and Christmas parties, and more.
If you would like to discuss the role or request reasonable adjustments, please email careers_uk@enseradesign.com.
Senior Design Quality Engineer in Bristol employer: Kinneir Dufort
Kinneir Dufort is an exceptional employer, offering a dynamic work culture in the heart of Bristol where innovation meets compliance in the MedTech industry. Employees benefit from flexible working arrangements, a competitive salary, and extensive training opportunities that foster professional growth, making it an ideal place for those looking to make a meaningful impact in medical device design.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Design Quality Engineer in Bristol
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device sector and let them know you're on the lookout for opportunities. A friendly chat can lead to insider info about openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of quality management systems and relevant regulations. We want you to feel confident discussing your experience with ISO 13485 and MDR, as these are hot topics in the industry.
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've guided teams through complex projects. Highlighting your ability to collaborate with engineers and designers will make you stand out.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Design Quality Engineer in Bristol
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experience mentioned in the job description. Highlight your relevant experience in quality engineering, especially in the medical device sector, to show us you're the right fit.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're passionate about this role. Share specific examples of how you've successfully guided teams through compliant development processes in the past.
Showcase Your Communication Skills:Since excellent communication is key for this role, ensure your application is clear and concise. Use straightforward language and structure your documents well to make it easy for us to see your qualifications.
Be Honest About Salary Expectations:When we ask for your expected salary, be upfront about what you think is fair based on your experience. This helps us understand your perspective and ensures we're on the same page from the start.
How to prepare for a job interview at Kinneir Dufort
✨Know Your Stuff
Make sure you brush up on the key regulations and standards mentioned in the job description, like ISO 13485 and MDR. Being able to discuss these confidently will show that you're not just familiar with them but can apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully guided teams through compliant development processes. Highlight your experience with medical devices and how you've interfaced with various stakeholders to drive quality work.
✨Ask Smart Questions
Come prepared with insightful questions about the company's quality management systems and their approach to design control. This shows your genuine interest in the role and helps you gauge if the company aligns with your values and work style.
✨Practice Your Presentation Skills
Since excellent communication is key for this role, practice articulating your thoughts clearly and concisely. You might even want to do a mock interview with a friend to get comfortable presenting your ideas and experiences.
