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- Tasks: Ensure design control processes for medical devices meet quality standards and regulations.
- Company: Cytiva, a life sciences leader dedicated to saving lives through innovation.
- Benefits: Comprehensive benefits, including healthcare and paid time off, enhancing your work-life balance.
- Why this job: Make a real impact in healthcare while working with passionate professionals.
- Qualifications: Degree in Science or Engineering and experience in Medical Device Product Development.
- Other info: Join a culture of belonging and continuous improvement with excellent career growth opportunities.
The predicted salary is between 36000 - 60000 £ per year.
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher’s operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The Role
The Design Control Specialist is responsible for establishing and maintaining the Design Control process for devices, filters and associated separation systems for global Pall Medical applications within the guidelines of an ISO 13485 and ISO 9001 compliant Quality Management System, and where relevant FDA 21 CFR 820, MDSAP and the EU Medical Device Regulation (MDR)
This position reports to the Director Medical Technology and is part of the Pall Medical Technology Team in Portsmouth, UK and will be an on-site role.
Responsibilities
- Responsible for ensuring that all Pall Medical design activities conform to Cytiva Design Control procedures throughout the product lifecycle, within the guidelines of ISO 13485 and ISO 9001 compliant Quality Management System, and where relevant FDA 21 CFR 820, MDSAP, and the EU Medical Device Regulation (MDR)
- Provide guidance to the Pall Medical Research and Development and Product Engineering teams in the preparation of design control documentation throughout the product lifecycle, including the preparation of Design History Files (DHFs)
- Responsible for leading a cross functional team in conducting product risk analysis to ISO 14971 and implementation of risk management strategies throughout the product lifecycle of Pall Medical products
- Work with cross functional technical teams to develop protocols for the verification and validation (V&V) testing of prototypes and finished products
- Contribute to the development and improvement of design and development processes to enhance efficiency and ensure product quality
Requirements
- Degree in Science or Engineering related subject or equivalent experience
- A strong background and significant experience within the field of Medical Device Product Development/Quality/Regulatory is essential
- In-depth knowledge of regulations and standards, such as ISO 13485, ISO 14971, FDA 21 CFR 820, and the EU Medical Device Regulation (MDR)
- A strong understanding of the overall design control process, including design inputs, outputs, verification, and validation
- Excellent written and verbal communication skills are necessary for effective collaboration and documentation.
Travel and Other Requirements
- Ability to travel – Limited travel to other Cytiva sites within UK and Europe
Nice to Have
- Lotus Notes Database management of Design History Files and other design documentation
- Veeva Vault Quality Management Software
Cytiva offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.
Cytiva is an equal opportunities employer. We are committed to equality of opportunity for all employees and applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
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Design Control Specialist employer: Danaher - Global
Contact Detail:
Danaher - Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Control Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching Cytiva and their products. Understand their mission and values, and think about how your skills align with their goals. This will help you stand out as a candidate who truly gets what they’re about.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to design control and regulatory standards. Being articulate about your experience will show you’re ready to hit the ground running.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining the team at Cytiva.
We think you need these skills to ace Design Control Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Design Control Specialist role. Highlight your experience with ISO standards and any relevant projects you've worked on. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about life sciences and how you can contribute to our mission at Cytiva. Let us know what makes you unique and why you want to join our team.
Showcase Your Communication Skills: Since excellent written communication is key for this role, make sure your application is clear and concise. We appreciate well-structured documents that are easy to read, so take your time to proofread before hitting send!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Danaher - Global
✨Know Your Regulations
Make sure you brush up on ISO 13485, ISO 14971, and FDA 21 CFR 820 before the interview. Being able to discuss these regulations confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Experience
Prepare specific examples from your past work in medical device product development or quality assurance. Highlight how you've contributed to design control processes and any cross-functional teamwork you've been part of. This will demonstrate your hands-on experience and problem-solving skills.
✨Communicate Clearly
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 refine your verbal skills and ensure you can explain complex concepts simply.
✨Ask Insightful Questions
Prepare thoughtful questions about Cytiva's design control processes and how they align with their commitment to innovation. This not only shows your interest in the role but also your understanding of the company's mission and values.