Back to Job Search

Design Assurance Quality Engineer

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 20939

Our client, a world leading medical device manufacturer based in Galway who are designing, developing and manufacturing their range of neurovascular devices are looking to hire a Design Assurance Engineer (HYBRID) as they embark on the expansion of their team and facility. The Design Assurance Engineer will be tasked with demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality. Understanding and complying with our clients quality, business, health & safety systems and market/legal regulations and removing or mitigating against risks associated with the design, use and manufacture of our clients devices.

Key Responsibilities

  • Lead the Design Review process in compliance to internal procedures including EU and FDA requirements.

  • Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records.

  • Work with product development to establish design specifications and product requirements

  • Ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements including MDD 93/42 EEC and FDA requirements.

  • Lead risk management process and preparation of risk management files including Use and Design FMEAs as required.

  • In conjunction with the design teams identify product testing required and write design verification and validation plans, protocols and reports including specifically advising on sample sizing; including but not limited to sterilization, Biocompatibility, Stability and Transportation testing

  • Liaise with external vendors for product testing 

  • Preparation of Standard Checklists for all the applicable main harmonized standards

  • Generation and/or review of quality and technical documentation / change requests to support design activities.

  • Routinely provides design assurance guidance and direction to engineers and/or technicians.

  • Assist Regulatory with the compilation of design dossiers, technical files, essential requirements, and regulatory submissions documentation as required

  • Support various QA/RA activities including quality management, system reviews, internal & vendor audits, etc.


  • Proven success in the following job competencies:

  • Application of standard regulatory requirements

  • Change control management; design, process and system.

  • Communication, Presentation and meeting chairing

  • Customer Focus

  • Medical Device Industry and/or Profession Expertise

  • Problem Solving and Decision Making

  • Proficiency in Design & Development processes including planning and reporting test requirements for each phase of the process.

  • Quality of Work; maintains high standards despite pressing deadlines

  • Risk Management

  • Design Verification including Ethylene Oxide sterilization, Biocompatibility, Stability and Transportation testing

Skills, Qualifications & Experience

  • Minimum 3 years’ experience as Design Assurance Engineer or similar role in a medical device company.

  • Primary and/or a postgraduate degree BS, MS, or PhD (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field).

  • Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.

  • Working knowledge of the Medical Device Directive (93/42/EEC) and FDA requirements including Quality System Regulation (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.

  • Previous experience in Ethylene Oxide sterilization, biocompatibility & transportation testing an advantage.

For more information on this position and a confidential discussion on the company please contact Chris O Toole

091 706713