Mark is Director at Arrotek, a company he co-founded at the age of 24. He has an educational background in aerospace engineering, enabling him to bring to the medical device industry his expertise in reliability, quality, and fault-free engineering, three areas of focus that remains central to everything that Arrotek does today. Mark has over 15 years’ experience in medical device design, development, and manufacturing, with specific expertise in the development of minimally invasive medical devices. As Director, he has also helped lead Arrotek, growing and expanding the company to the strong position it is in today.

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With over 15 years’ experience in the medical device industry, Shane has worked in various roles, including research & development and manufacturing. His expertise includes Design for Manufacture (DfM) and ensuring a smooth transition as products move to scaled-up production. Previous projects Shane has worked on include electromechanical devices, such as a neonatal critical care ventilator, as well as urology devices, cardiac care devices, IV sets for perinatal nutrition/pain management, and various other delivery systems. His educational background is in mechanical engineering and biomedical engineering, and he has extensive experience in a range of manufacturing technologies.

Fidelma’s expertise includes ensuring the quality management systems (QMS) of new medical device products meet the required standards for quality, compliance, and accreditation. Fidelma has over 21 years’ experience in the pharmaceutical and medical device industries, and she manages a team of quality professionals at Arrotek. She is also responsible for managing Arrotek’s QMS, and ensuring adherence to company, external, and regulatory requirements. Fidelma’s responsibilities also include ensuring products are manufactured to required quality specifications, liaising with customers, managing quality metrics, and providing support on all quality assurance activities.

Adrian’s responsibilities at Arrotek include leading teams through the design and development process on various medical device product development projects. He has over 20 years’ experience in the engineering industry, including in design and development as well as processes of manufacture. Adrian has successfully transferred Class II and Class III medical device products from concept to CE mark approval. He has an excellent working knowledge of SolidWorks design, quality management systems, tool design, process validation, and more. Adrian has an honours degree in manufacturing technology/mechanical engineering.

Ciaran has a background in the food processing industry, working in roles that include design, production management, and project management. This experience includes working on large overseas projects for a global solutions company in the food processing industry. He has a BSc in Mechatronics. At Arrotek, Ciaran’s responsibilities include managing medical device design and development projects, varying from implantable grafts to electronic micro-injector devices. He has extensive knowledge of manufacturing processes, CAD, tool design and manufacture, and managing complex projects from the initial concept stage to completion.

Dermot is responsible for managing the manufacturing function at Arrotek, ensuring the accurate execution of production schedules and managing the supply chain. He also has extensive expertise identifying and implementing sustainable production improvements that enhance productivity and achieve lean manufacturing goals. Dermot has over seven years’ experience as a production manager, including in the medical device industry. His educational background is in electronic engineering. He is also trained to conduct internal audits and has experience in Six Sigma, achieving a green belt in manufacturing.

As a design engineer, Jake has been involved in a number of medical device design projects at Arrotek, using his skills and expanding his knowledge and experience. That experience covers various medical device products, including balloon catheter manufacture, urinary catheter systems, handheld delivery devices, and more. Jake also has prototyping and rendering expertise. He has an engineering background and a degree in product design and technology.

As a Quality Assurance Engineer at Arrotek, Aine’s responsibilities include overseeing manufacturing records, material specifications reviews, work instructions, and training records. Aine has a degree in pharmaceutical science and has knowledge and experience both as a quality engineer and validation engineer in the medical device industry. She has also enhanced her knowledge of validation through Irish MedTech Association training, and she has Six Sigma knowledge, having attained a LEAN white belt.

Working in the medical device industry, Laura has experience in a range of specialist areas, including sterile and non-sterile final product testing, nonconformity management, corrective action preventative action (CAPA), customer complaint management, risk management, product release processes, personal training, and the creation of design files for medical device products. Laura’s responsibilities at Arrotek include ensuring medical device design projects meet quality goals from prototypes to design input/output to design verification, and more. Laura has an educational background in applied biology and biopharmaceutical science.

Sean specialises in medical device design and development projects and has expertise in concept design, prototyping, and testing. He also has extensive experience creating detailed documentation for new medical devices to support manufacturing activities and ensure production processes successfully achieve the desired product specification. Sean’s areas of knowledge include long-term implantable devices, technological microcurrent devices used to treat cardiovascular diseases, and microcatheters to alleviate calcification in coronary arteries. Sean has an educational background in biomedical engineering.