Senior R&D Engineer

My client are searching for a Senior R&D Engineer to join their Athlone site. You will be focusing on the development of cutting-edge medical devices in the Airway Management space and be directly involved in the development of innovative products for use in medical procedures in line with Global Marketing product pipelines & Customer needs.

Responsibilities:

• You’ll be responsible for R&D Engineering with respect to developing device designs, testing methods, problem resolution, and analysis of customer feedback
• May assist customer in device usage problems or customer testing of complex designs
• As part of the EU MDR Compliance project, work with Manufacturing team in terms of design and manufacturability of Airways Management devices to MDR requirements
• Design or specify Manufacturing inspection and testing mechanisms and equipment
• Work with line supervisor and process validation team in terms of establishing gaps in the Project Validation Master Plans, creating schedules/timelines to address same and regularly reviewing the Master Validation Plans for adequacy
• As part of a team, support the completion of Risk Management to include the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis etc. to all product groups
• Suggest relevant changes to procedures and update to standard operating procedures as necessary
• Liaise with cross functional team members, developing strong partnering relationships with these to establish inspection methods which ensure effective product acceptance actives

Skills and Experience:

• Bachelor / Master’s Degree level in Mechanical, Polymer, Biomedical or related Engineering /Science discipline and desirably with 6-7 years relevant experience
• Experience in the design and development of new products in the Medical Device Industry
• Good knowledge of Design for Six Sigma (DFSS) / Design Reliability Manufacturability (DRM) and CAD (Solidworks)
• Familiar with problem solving techniques and methodologies
• Broad biomedical materials knowledge, with knowledge of processing and joining technologies also
• Basic knowledge of quality and regulatory requirements, e.g regulatory requirements from agencies or outside professional groups (e.g. FDA, ISO, ANSI,) and knowledge of EU MDR
• Ability to adjust or recommend enhancements to systems and processes to solve problems or improve effectiveness of job area
• Experience interfacing with clinicians and reducing feedback to device concepts
• Experience with testing methods, procedures, and problems; device specification and yield problems; analysis of customer returns; supplier related engineering changes and optimizing device production relative to cost constraints
• Can work independently with general supervision on larger, moderately complex projects
• A dynamic player and can work effectively on cross-functional teams

For further information on this Senior R&D role in Athlone please contact Amanda Reynolds on 0860468858/ technical@hero.ie

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Amanda Reynolds

JOB-11360