Design Assurance Engineer | Collins McNicholas

Design Assurance Engineer

  • Reference: GY45603EFx
  • Job Type: Permanent
  • Location: Galway, Galway City
  • Category: Engineering, Technical & Manufacturing

I am looking for talented Design Assurance Engineer with Medical Devices manufacturing experience.

Technical requirements:

  • Provides both quality and technical input to the design reviews, project development/ design change/recertification plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.

  • Experienced in validation techniques, risk management, statistical techniques and compliance to regulatory requirements. Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.

  • Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.

  • Excellent analytical and problem solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.

  • Updates Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group.

  • Is an active team member completing quality deliverables associated with product development and sustaining engineering projects.

  • Coaches others in areas of expertise. Gives technical guidance to Design Assurance Engineer I, Graduate Design Assurance Engineer and Design Assurance Technicians.

  • Is a good team member, fully motivated to achieve and demonstrate best practices in line with the project, department and site objectives.

  • Supervision and development of staff reporting to them in line with departmental and project goals.

  • Uses opportunities in project assignments to develop self & other team members.

  • Provides guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with Corporate SOP’s.

  • Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.

Minimum Qualifications:

  • HETCA Level 8 in a relevant area with a minimum of 5 years’ experience in a similar environment.


For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or email

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Edyta Fleming

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  • Edyta Fleming
  • Recruitment Consultant
  • 091 706721
  • Connect with Edyta
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