Gareth Wynne

Director of Medical Device Physical Testing Operations in United Kingdom

An experienced leader with a demonstrated history of working in the Pharmaceutical and Medical Device industry for over 14 years. Gareth is responsible for the Medical Device Physical Testing business based with the Smithers Shawbury site, as well as the site's Health and Safety lead.

Expertise

Gareth is the Operations Director for the Medical Device Testing team at our Shawbury site, overseeing all aspects of the business. During his time in industry, as a qualified engineer and a senior manager, he has developed his skills across both manufacturing and research and development. He has a working knowledge of the development process and design controls / regulatory requirements for device submissions, specific expertise in development of combinational products – injection delivery systems.

Qualifications

Following Gareth attaining his Mechanical Engineering degree, he has also benefited from formal training programs in design and development for medical devices such as AMMI Design Control - 21 CFR 820.30,  ISO 13485 & ISO14971, Medical Device Risk Management and Human Factors Engineering courses. While working in manufacture engineering for 8 years he’s also attained a green belt in Six Sigma, and is well practiced in process validation requirements for production.

Contact Gareth

Call: +44 (0)1939 252 486

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