Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie

Senior R&D Engineer – Product Development

Job ID: JOB-11404

Senior R&D Engineer – Product Development

My MNC Medical Device Client are ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies and are searching for a Senior R&D Engineer to lead and be an integral part of a team developing the company’s portfolio of platform delivery system products.

This role requires you to have significant product development experience in the medical device arena and be be comfortable leading and developing a team to develop Creganna’s products. You will report to the Group Leader and be based at HQ in Galway. 

As a part of the R&D/Product Development Engineering Team you will conceive original ideas for new products and introduce them into practice. You will be responsible for product development, and qualification from market definition through production and release; assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes; conduct feasibility studies, testing on new and modified designs; direct and support detailed design, testing, prototype fabrication and manufacturing ramp.

 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 

Qualifications & Requirements

 

  • Level 8 Engineering, science or equivalent degree
  • 5 to 8 Year’s 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 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 modelling experience
  • Working knowledge of biocompatible metal and/or polymer materials

Company Benefits

  • Annual bonus
  • Health insurance 
  • Life Assurance
  • Pension
  • Christmas bonus voucher
  • Paid holidays
  • Free parking & overflow carpark
  • Subsidised canteen
  • Laptop
  • Sports & Social membership
  • Training & development opportunities
  • Educational Assistance

 

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

 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

 

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Amanda Reynolds

JOB-11404

Senior R&D Engineer – Product Development

Amanda Reynolds

Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie
mobile +353 86 046 88 58
linkedIn profile click here

Senior Quality Engineer – Process Validation

Galway

Job ID: JOB-11736 Senior Quality Engineer – Process Validation A leading medical device manufacturer in Galway is recruiting for a…

 

Read More

Senior Operations Manager

Galway

Job ID: JOB-11735 Senior Operations Manager Our client a medical device MNC is recruiting for a leadership role in Galway….

 

Read More

Planner/Buyer

Galway

Job ID: JOB-11731 Planner/Buyer Our client in South County Galway is recruiting for a planner/buyer to join their team, you…

 

Read More