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- Tasks: Lead design control and risk management for medical device development.
- Company: Join a top biopharmaceutical company improving lives with innovative medicines.
- Benefits: Competitive pay rates and the chance to work on impactful projects.
- Why this job: Be part of a mission-driven team making a difference in healthcare.
- Qualifications: Relevant scientific degree or equivalent experience required.
- Other info: Location: Cambridge; must have UK work entitlement.
CK Group are recruiting for a Design Control Engineer, to join a company in the pharmaceutical industry, on a contract basis for 12 months.
Salary: From £16.76 to £20.79 per hour PAYE or £18.78 to £23.30 per hour UMB.
Design Control Engineer Role:
- Lead design control and risk management activities for medical device combination product development programmes.
- Support and facilitation of effective design control and risk management activities internally, at external design companies, and at the clients manufacturing facilities/CMOs.
- Ensure medical device combination product design control and risk management activities are compliant with quality and regulatory standards, both internal and external.
- Provide input and support to design validation including, but not limited to, use-related risk assessments.
- Support the generation of all regulatory submission data and content for assigned medical device combination product projects.
Your Background:
- Hold a relevant scientific degree or have equivalent working experience.
- Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Experience in design control and risk management for medical device combination products and/or medical devices.
- Familiar with Human Factors Engineering - Usability Engineering.
- Familiar with device assembling manufacturing processes.
Company: Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
Location: This role is based at our clients site in Cambridge.
Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 141 245 in all correspondence. Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
If this position isn’t suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.
Design Control Engineer employer: New Scientist
Contact Detail:
New Scientist Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Control Engineer
✨Tip Number 1
Familiarise yourself with the specific ISO standards mentioned in the job description, such as ISO 9001 and ISO 13485. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance in design control.
✨Tip Number 2
Network with professionals in the pharmaceutical and medical device industries. Attend relevant conferences or webinars where you can meet people who work in design control. This could lead to valuable insights and potential referrals for the role.
✨Tip Number 3
Brush up on your knowledge of Human Factors Engineering and Usability Engineering. Being able to discuss how these concepts apply to design control will set you apart from other candidates and show your depth of understanding.
✨Tip Number 4
Prepare to discuss your previous experience with risk management activities in detail. Be ready to provide examples of how you've successfully led design control projects, as this will highlight your practical skills and suitability for the role.
We think you need these skills to ace Design Control Engineer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the responsibilities and requirements of the Design Control Engineer position. Tailor your application to highlight relevant experience in design control and risk management for medical devices.
Highlight Relevant Experience: In your CV and cover letter, emphasise your working knowledge of ISO standards and any specific experience you have with medical device combination products. Use concrete examples to demonstrate your expertise in design validation and risk assessments.
Craft a Strong Cover Letter: Write a compelling 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 of improving lives through innovative biopharmaceuticals.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role in design control.
How to prepare for a job interview at New Scientist
✨Know Your Standards
Familiarise yourself with ISO 9001, ISO 13485, and ISO 14971. Being able to discuss these standards confidently will show that you understand the regulatory landscape of the pharmaceutical industry.
✨Demonstrate Risk Management Skills
Prepare examples of how you've successfully led design control and risk management activities in previous roles. Highlight specific challenges you faced and how you overcame them.
✨Showcase Your Technical Knowledge
Be ready to discuss your experience with medical device combination products and Human Factors Engineering. This will demonstrate your technical expertise and relevance to the role.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's design validation processes and their approach to compliance. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
