R&D Catheter Development Engineer- County Galway.
In this role you will work as part of the R&D team tasked with the development of new medical device products in compliance with applicable regulations including EU and FDA regulations.
• Develop products and corresponding processes which meet the customer requirements throughout the design phase.
• Ensuring the product & processes are designed efficiently to ensure commercial success.
• Generate technical documentation for the Product Design History File and Device Master Records.
• Establish and maintain appropriate Manufacturing documentation including Equipment documentation, Bills of Materials, Product routings, Manufacturing procedures and Logs.
• Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
• Develop test methods for product evaluation and validation. Develop and execute test method validations.
• Liaise with project leads to understand product development requirements and processes associated with new product design.
• Partner with Manufacturing Engineering, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
• As part of the R&D team, contribute effectively to the broader technical and resource needs of the team while ensuring specific technical expertise is continually developed and strengthened.
Qualifications and Experience Sought:
An Engineering or Science Degree.
A minimum of 4 years' post-qualification experience within a Medical Device environment, with at least two spent in R&D.
Catheter knowledge an advantage for this role
Ideally agood knowledge of catheter development.
A good knowledge of design life cycles requirements.
An analytical approach to problem solving.