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 hourly pay and the chance to work on impactful projects.
- Other info: Location: Cambridge; must have UK work entitlement.
- Why this job: Be part of a mission-driven team in a dynamic industry with growth opportunities.
- Qualifications: Relevant scientific degree or equivalent experience; knowledge of regulatory standards required.
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. This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
Design Control Engineer in Cambridge employer: CK Group
As a leading biopharmaceutical company, we offer a dynamic work environment in Cambridge that fosters innovation and collaboration. Our commitment to employee growth is reflected in our comprehensive training programmes and opportunities for career advancement, while our supportive culture prioritises work-life balance and employee well-being. Join us to be part of a mission-driven team dedicated to improving lives through cutting-edge medical solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Design Control Engineer in Cambridge
✨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 boost your confidence during interviews but also demonstrate your commitment to compliance in design control.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in medical device development. Engaging with them on platforms like LinkedIn can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with risk management and design control in detail. Be ready to share specific examples of how you've applied these principles in past projects, as this will showcase your expertise and problem-solving skills.
✨Tip Number 4
Research the company’s recent projects and innovations in the biopharmaceutical field. Being knowledgeable about their work will help you tailor your conversation during interviews and show your genuine interest in contributing to their mission.
We think you need these skills to ace Design Control Engineer in Cambridge
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. Highlight key skills such as design control, risk management, and knowledge of relevant regulations.
Tailor Your CV:Customise your CV to reflect your experience in design control and risk management for medical devices. Include specific examples that demonstrate your familiarity with ISO standards and any relevant projects you've worked on.
Craft a Compelling Cover Letter:Write a cover letter that connects your background to the job requirements. Emphasise your scientific degree or equivalent experience, and mention your understanding of Human Factors Engineering and usability engineering.
Follow Application Instructions:Ensure you include the job reference number (141 245) in your application. Double-check that you meet the eligibility criteria to work in the UK and that all documents are complete 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, and ISO 14971. Be prepared to discuss how these standards apply to design control and risk management in medical devices, as this knowledge will demonstrate your expertise in the field.
✨Showcase Your Experience
Be ready to share specific examples from your past work that highlight your experience in design control and risk management for medical device combination products. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Understand Human Factors Engineering
Brush up on Human Factors Engineering and Usability Engineering principles. Be prepared to explain how you have applied these concepts in previous projects, as they are crucial for ensuring user safety and product effectiveness.
✨Prepare for Regulatory Questions
Expect questions about regulatory submission processes and compliance. Review the EU Medical Devices Regulation and be ready to discuss how you would ensure that design control activities meet both internal and external quality standards.
