At a Glance
- 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, contract role, and the chance to work on impactful projects.
- Other info: Location in Cambridge; DBS check required.
- Why this job: Be part of a mission-driven team making a difference in healthcare.
- Qualifications: Relevant scientific degree or equivalent experience in medical device design control.
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.
INDKA
Design Control Engineer in Huntingdon employer: CK Group
As a leading biopharmaceutical company, our client offers a dynamic work environment in Cambridge, where innovation and collaboration thrive. Employees benefit from competitive pay, comprehensive training, and opportunities for professional growth, all while contributing to the development of life-changing medicines and healthcare products that impact millions globally. Join a culture that values integrity, excellence, and teamwork, making it an exceptional place for passionate individuals seeking meaningful careers in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Design Control Engineer in Huntingdon
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 9001, ISO 13485, and 21 CFR 820. Being able to discuss these in detail during your interview will show that you have the necessary knowledge and are serious about the role.
✨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 and risk management. This could lead to valuable connections and insights that may help you stand out.
✨Tip Number 3
Prepare to discuss your experience with design validation and risk assessments in detail. Think of specific examples from your past work that demonstrate your ability to manage these processes effectively, as this is a key part of the role.
✨Tip Number 4
Research the company thoroughly before your interview. Understand their products, values, and recent developments in the biopharmaceutical field. This will not only help you tailor your responses but also show your genuine interest in joining their team.
We think you need these skills to ace Design Control Engineer in Huntingdon
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights relevant experience in design control and risk management, particularly in the pharmaceutical or medical device sectors. Use keywords from the job description to demonstrate your fit for the role.
Craft a Strong Cover Letter:Write a cover letter that specifically addresses the requirements listed in the job description. Mention your familiarity with ISO standards and any relevant projects you've worked on that align with the responsibilities of the Design Control Engineer role.
Showcase Relevant Skills:In your application, emphasise your knowledge of Human Factors Engineering and usability engineering. Provide examples of how you've applied these skills in past roles, especially in relation to medical devices.
Follow Application Instructions:Ensure you quote the job reference 141 245 in all correspondence and confirm your entitlement to work in the UK. Double-check that all required documents are included before submitting your application through our website.
How to prepare for a job interview at CK Group
✨Know Your Standards
Familiarise yourself with ISO 9001, ISO 13485, ISO 14971, and the relevant CFRs. Being able to discuss these standards confidently will show your understanding of the regulatory landscape in the pharmaceutical industry.
✨Demonstrate Design Control Experience
Prepare specific examples from your past work where you led design control and risk management activities. Highlight your role in ensuring compliance and how you contributed to successful project outcomes.
✨Understand Human Factors Engineering
Brush up on usability engineering principles and be ready to discuss how they apply to medical device development. This knowledge is crucial for addressing user-related risks effectively.
✨Showcase Your Teamwork Skills
Since the role involves collaboration with external design companies and manufacturing facilities, be prepared to share experiences that demonstrate your ability to work well in a team and facilitate effective communication.
