Senior Design Assurance Engineer

4 days ago

Galway, Ireland Barrington James Full time

Overview
We are partnering with a growing medical device company to appoint a Senior Design Assurance Engineer in Galway.
This role will give you the chance to take ownership of QA activities across the full product lifecycle, from design and development through to commercialisation.
Responsibilities
Lead risk assessments, design verification/validation, and DHF management.
Review and approve technical documentation in line with ISO 13485 and FDA 21 CFR Part 820.
Act as SME for audits and regulatory inspections.
Partner with R&D and Manufacturing Engineering to translate design requirements into manufacturing processes.
Support CAPA, audits, and continuous improvement activities.
Mentor junior staff and provide QA guidance across teams.
Qualifications
Bachelor's degree in Engineering, Science, or related field.
5+ years' QA/RA experience in the medical device industry.
Strong background in design assurance and product development.
In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR.
Experience supporting notified body/FDA inspections.
Strong communicator, problem solver, and team player.
Additional details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Medical Equipment Manufacturing
#J-18808-Ljbffr

  • Senior Design Assurance Engineer

    7 days ago

    Galway, Ireland Wallace Myers International Full time

    Position: Senior Design Assurance Engineer The Senior Design Assurance Engineer will act as the QA technical and compliance expert within a cross-functional team, supporting the design and development of sterile and non-sterile medical devices, as well as subsequent modifications, in line with regulatory requirements (ISO 13485, 21 CFR 820/QMSR, and other...

  • Senior Design Assurance Engineer

    7 days ago

    Galway, Ireland Wallace Myers International Full time

    Position: Senior Design Assurance EngineerRole Overview The Senior Design Assurance Engineer will act as the QA technical and compliance expert within a cross-functional team, supporting the design and development of sterile and non-sterile medical devices, as well as subsequent modifications, in line with regulatory requirements (ISO 13485, 21 CFR 820/QMSR,...

  • Senior Design Assurance Engineer

    2 days ago

    Galway, Ireland Medtronic Full time

    OverviewAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.Within our Structural Heart Design Assurance Group in Medtronic, plc, we focus on providing Quality support...

  • Senior Design Assurance Engineer

    6 days ago

    Galway, Ireland Versono Medical Ltd Full time

    Position:Senior Design Assurance EngineerThe role of Senior Design Assurance Engineer is to be the QA technical and compliance expert as part of a cross functional team for the design and development of sterile and non sterile medical devices and /or subsequent modifications thereafter in compliance to current Regulatory requirements i.e. ISO 13485, CFR 820...

  • Design Assurance Engineer

    2 weeks ago

    Galway, Galway, Ireland AMA Consulting Group LLC Full time

    Neurent Medical is seeking a highly motivated and experienced Design Assurance Engineer to join our team. This individual will play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and...

  • Design Assurance Engineer

    2 weeks ago

    Galway, Galway, Ireland AMA Consulting Group LLC Full time

    Neurent Medical is seeking a highly motivated and experienced Design Assurance Engineer to join our team. This individual will play a key role in supporting the lifecycle of our commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and...

  • Senior Design Assurance Engineer

    3 weeks ago

    Galway, Galway, Ireland Medtronic Vascular Galway UC Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life Medtronic At Medtronic, we value what makes you unique.Be part of a company that thinks differently...

  • Senior Design Assurance Engineer

    2 weeks ago

    Galway, Galway, Ireland Medtronic Vascular Galway Uc Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life Medtronic At Medtronic, we value what makes you unique.Be part of a company that thinks differently...

  • Senior Design Assurance Engineer

    6 days ago

    Galway, Ireland Medtronic Vascular Galway Uc Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life Medtronic At Medtronic, we value what makes you unique.Be part of a company that thinks differently...

  • Senior Design Assurance Engineer

    2 days ago

    Galway, Ireland Medtronic Vascular Galway Uc Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life Medtronic At Medtronic, we value what makes you unique.Be part of a company that thinks differently...