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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.
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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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