Senior Medical Device Design Engineer with at least 5 years experience in medical device product design development required by market leading Medical Device multinational based in Galway.

Responsibilities:

  • Lead and be an integral part of the team tasked with the development process from concept generation through to design verification
  • Assist in the development of intellectual property generated by development activities
  • Ensure the application of new and existing technologies to provide the optimum delivery system design
  • Participate in trials with physicians to provide clinically relevant feedback on product designs
  • Provide technical feedback during frequent technical contact with customers to optimise product design
  • Support the maintenance of product files and other relevant documentation to comply with quality standards
  • Compile project plans and lead team to develop devices in accordance with planned activities, budget and timelines

Requirements:

  • Level 8 or Masters in Engineering/Science or similar technical field from an accredited college or university
  • 5+ years’ experience in medical device product design development
  • Strong ability to lead project teams through key milestones, from concept to transfer into manufacturing
  • Excellent knowledge and understanding of the Quality and Regulatory requirements associated with all phases of product design and development
  • Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirement
  • Strong ability to lead project teams through key milestones, from concept to transfer into manufacturing
  • Excellent knowledge and understanding of the Quality and Regulatory requirements associated with all phases of product design and development
  • Excellent communication and interpersonal skills, in particular focusing on working with customers and the leadership of teams. The person will have previous exposure to working with and meeting customer & sales expectations
  • Ability to maintain multiple projects simultaneously is essential

Please contact Emer Smith to discuss this urgent requirement in confidence

00353578638188

emer@emtechrecruitment.ie 

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