Title: Senior Product Development Engineer
• Work with Clinicians and end users to establish a detailed brief of the device
• Develop the concepts, detailed design and device spec.
• Perform continual testing both physical and mathematical.
• Manage the Design Project and the Design History File to conform to our ISO 13485 Controls
• Establish suppliers and manufacturing agents and develop the supply chain strategy for the product.
• Help to define the commercial road map for the product once it exits the EI funded Commercial Funding.
• Develop contacts in key clinical areas and focus on the discovery and need for innovative devices within that area.
After Paddy completed his Product Design degree his first 2 positions were in the design and development of large steel structures and machinery.
Paddy was immediately responsible for directly programming laser cutting machines, designing the fixtures and welding the assemblies.
Realising the need for lots of experience to increase his skill set lead Paddy to start his own small company and to take on contract projects. The clients that Paddy worked with were greatly varied from many different industries, these included Cook Ireland; Stryker; BAE systems; Logitech; Aerogen; BMR; Molex Ireland; ABB; to name only the large companies. He also worked very closely with small start-up companies, acting as their outsourced Design Department.
Title: Centre Director
Title: Support Engineer
• Industrial Design
• CAD technician
• 3D printer management
• Prototyping work shop management
• Assisting Design engineers with parts and assemblies
• Website design and management
Graduate of the National College of Art and Design with B. Des. in Industrial Design.
Since graduating John has gone on to work within the product design industry for many different multinational companies including consumer electronics and medical device design.
Specialising in concept design and development John has many years of experience working at every stage of the product development process, research, Ideate, prototype, test and eventual product launch.
John has also spent a number of years working within education teaching prototyping skills and creative thinking techniques to undergraduate students at NUI Maynooth.
Title: Senior QA/RA Specialist
• Development and maintenance of ISO 13485 certified quality system.
• Support design team in the creation of design history file and risk management file.
• Regulatory assessments and submissions.
Gayle spent 11 years in the medical device sector, working in a number of QA/RA positions. Some of Gayle’s most notable achievements during this time include
• Successfully managing the transition from ISO 9001 to ISO 13485 certification
• Providing regulatory support to new product development teams in bringing new medical devices to market
• Developing a number of QA/RA processes under FDA scrutiny, including Complaint handling, MDR reporting and Product Field Action and CAPA processes.
• Developing and implementing a new approach to risk management, across multiple medical device sites.
The MEDIC team is comprised of a group of talented, dedicated, hard working engineers, designers and quality specialists.
Each individual brings with them a unique set of skills and experience, allowing MEDIC to feed from a collective knowledge base providing true understanding and insight to every project.
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