At a Glance
- Tasks: Lead design control and risk management for innovative medical devices.
- Company: Join a world-renowned biopharma organisation in a hybrid work environment.
- Benefits: Competitive rate of £28.20 per hour plus holiday entitlement.
- Other info: Dynamic role with opportunities for professional growth and development.
- Why this job: Make a real impact on healthcare by ensuring product quality and compliance.
- Qualifications: Degree in Engineering or Life Sciences with experience in medical devices.
The predicted salary is between 55000 - 60000 £ per year.
Atrium (EMEA) is partnering with a leading global biopharma organisation to hire a Quality Engineer. The candidate will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle.
- Lead design control and risk management activities for product development programmes
- Ensure compliance with regulatory and quality standards (ISO, FDA, EU MDR)
- Prepare and review design history files and risk management documentation
- Support design validation activities, including human factors engineering
- Contribute to regulatory submissions and audit readiness
- Assist with device investigations for clinical and commercial products
Requirements:
- Degree (BSc/MSc/PhD) in Engineering, Life Sciences, or related discipline
- Experience in medical devices or combination products
- Experience of writing regulatory submissions, specifically BLA, NDA and NbOP
- Extensive knowledge of device design controls, human factors and risk management
- Strong knowledge of design controls & risk management
- EU Medical Devices Regulation
- Understanding of Human Factors / Usability Engineering
- Knowledge of GMP and quality systems
Work with a world-renowned pharmaceutical organisation.
Technisch engineer. employer: Atrium
As a Quality Engineer at our leading global biopharma organisation in Cambridge, you will thrive in a dynamic hybrid work environment that fosters innovation and collaboration. We prioritise employee growth through continuous learning opportunities and a supportive culture that values compliance and quality standards. Join us to make a meaningful impact in the medical device sector while enjoying competitive pay and holiday entitlement.
StudySmarter Expert Advice🤫
We think this is how you could land Technisch engineer.
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharma and medical device sectors on LinkedIn. Join relevant groups and engage in discussions to get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO, FDA, and EU MDR standards. We want you to be able to speak confidently about design controls and risk management during those crucial conversations.
✨Tip Number 3
Don’t just apply; follow up! After submitting your application through our website, drop a quick email to express your enthusiasm. It shows initiative and keeps you on their radar.
✨Tip Number 4
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers, especially around human factors engineering and regulatory submissions. The more comfortable you are, the better you'll perform!
We think you need these skills to ace Technisch engineer.
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience in medical devices and any relevant projects you've worked on. We want to see how your skills match what we're looking for!
Showcase Your Expertise:In your cover letter, showcase your expertise in design control and risk management. Give us examples of how you've contributed to product development programmes and ensured compliance with regulatory standards.
Be Clear and Concise:Keep your application clear and concise. Use bullet points where possible to make it easy for us to read. We appreciate a straightforward approach that gets to the point without unnecessary fluff!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Atrium
✨Know Your Stuff
Make sure you brush up on your knowledge of design controls, risk management, and regulatory standards like ISO and FDA. Being able to discuss these topics confidently will show that you're not just familiar with the theory but can apply it practically.
✨Showcase Relevant Experience
Prepare specific examples from your past work in medical devices or combination products. Highlight your experience with writing regulatory submissions and how you've contributed to design validation activities. This will help demonstrate your hands-on expertise.
✨Understand the Company
Do a bit of homework on the biopharma organisation you're interviewing with. Familiarise yourself with their products, values, and recent news. This will not only help you tailor your answers but also show your genuine interest in the role and the company.
✨Ask Smart Questions
Prepare thoughtful questions about the company's approach to quality engineering and how they handle compliance with EU MDR. This shows that you're engaged and thinking critically about the role, plus it gives you insight into whether the company is the right fit for you.
