Collins McNicholas

Primary Objectives of Position:

As part of the Design Engineering team at our Parkmore facility the Senior Research & Design Engineer will lead and be an integral part of a team developing our clients 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, and the position will be based in our Parkmore facility.  
 
Major Accountabilities:

  • 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:

  • An engineering, science or equivalent degree. 
  • 5 year’s industry experience in a medical product development environment with a proven track record of leading teams in device development. 
  • Experience of 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 of minimally invasive Medical Device design, development and manufacturing.
  • Proven experience in leading teams performing FMEA’s, verifications and validations for medical devices products and processes. Knowledge and experience with Medical Device sterilisation processes, specifically gamma and EtO sterilisation.
  • Proven experience of work 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 a confidential discussion and more information on the role/company please email your CV to: christopher.otoole@collinsmcnicholas.ie or give me a call on 091706713

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