Senior R&D/Product Design Engineer

HERO Recruitment
Employment Type
Not disclosed
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Senior R&D/Product Design Engineer

Our client is a $12 billion global technology leader. Their connectivity and sensor solutions are essential in today’s increasingly connected world. They collaborate with engineers to transform their concepts into creations by redefining what’s possible using intelligent, efficient, and high-performing products and solutions proven in harsh environments. Their 72,000 people, including over 7,000 engineers, partner with customers in over 150 countries across a wide range of industries. They believe EVERY CONNECTION COUNTS.
As part of the R&D Engineering team, the Senior R&D Engineer will lead and be an integral part of a team developing our client’s portfolio of platform delivery system products. This position requires a candidate with significant product development experience in the medical device arena and one who will be comfortable leading and developing a team to develop our client’s products. She/he will report to the Group Leader.

Job 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 the team to develop devices in accordance with planned activities, budget, and time lines.

What your background should look like:

  • Level 8 engineering, science, or equivalent degree.
  • 5 to 8 years of industry experience in a medical product development environment with a proven track record of leading teams in device development.
  • Experience in coordinating and leading Design Reviews and the compilation of associated documentation.
  • Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities.
  • Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
  • Proven experience in minimally invasive Medical Device design, development and manufacturing.
  • Proven experience in leading teams performing FMEAs, verifications, and validations for medical devices products and processes.
  • Knowledge and experience with Medical Device sterilization processes, specifically gamma and EtO sterilization.
  • Proven experience in working with catheter technology, catheter design and testing, and catheter manufacturing a distinct advantage.
  • Experience with engineering tools such as DOE, SPC, and using Minitab 3D modeling experience.
  • Working knowledge of biocompatible metal and/or polymer materials. Demonstrate a working knowledge of the required activities and deliverables from each of the development phases.
  • Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.

For further information on this Senior R&D/Product Design Engineer role in Galway please contact Shannon McCrossan on 086 8168273/

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