Design Assurance Engineer

2 weeks ago

Galway, Galway, Ireland Actalent Full time

We are seeking a highly motivated and experienced Design Assurance Engineer to join a Medical device company in Galway. This role involves supporting the lifecycle of medical device products, managing design changes, ensuring compliance with risk management and design control requirements, and supporting complaint investigations to ensure safety and effectiveness.

Responsibilities include:

  • Supporting commercial projects from a Design Assurance perspective, ensuring products meet global standards throughout their lifecycle.
  • Leading and executing product and material design changes in compliance with regulatory and internal quality systems, with expertise in assessing design, usability, sterilisation, biocompatibility, and clinical impact.
  • Providing technical direction on process changes in collaboration with R&D and Manufacturing Engineering.
  • Applying risk management concepts to meet FDA, ISO, and other regulatory requirements.
  • Maintaining the risk management file for post-market products, documenting and mitigating risks, and assessing product/process changes.
  • Generating and executing Design Verification plans, protocols, reports, and supporting regulatory submissions.
  • Ensuring design control compliance, including DHF maintenance, verification/validation planning, and traceability.
  • Supporting complaint investigations, root cause analysis, and CAPA activities.
  • Staying updated on regulatory requirements for product design and development.
  • Contributing to design and manufacturing documentation, including specifications and procedures, and managing change requests.
  • Assisting in regulatory submissions and audits with documentation and expertise.
  • Collaborating across departments to implement and document product changes and foster strong cross-functional relationships.
  • Driving continuous improvement in design assurance processes.
  • Mentoring junior engineers as needed.

Skills required:

  • Research & Development (R&D)
  • Design control and assurance
  • Validation processes
  • Proficiency in Microsoft Office
  • Testing methods
  • Regulatory knowledge (FDA, ISO)
  • Biocompatibility
  • Mechanical engineering

Employee Value Proposition:

Opportunity to work across multiple departments with a manager committed to professional development. The company is expected to grow significantly over the next three years, having recently received FDA approval as of June.

Details:

  • Job Title: Design Assurance Engineer
  • Location: Galway, Ireland
  • Type: Permanent
#J-18808-Ljbffr

  • Design Quality Assurance Engineer

    1 week ago

    Galway, Galway, Ireland Nordson Medical Ireland Limited Full time

    Design Quality Assurance Engineer page is loadedDesign Quality Assurance EngineerApply locations Ireland - Galway time type Full time posted on Posted 30+ Days Ago job requisition id REQ45745Nordson Medical, a global leader in the medical device industry, is seeking an experienced and highly motivated individual to join our team inGalway, Irelandas aDesign...

  • Design Quality Assurance Engineer

    2 weeks ago

    Galway, Galway, Ireland Nordson MEDICAL Ireland Limited Full time

    Design Quality Assurance Engineer page is loadedDesign Quality Assurance EngineerApply locations Ireland - Galway time type Full time posted on Posted 30+ Days Ago job requisition id REQ45745Nordson Medical, a global leader in the medical device industry, is seeking an experienced and highly motivated individual to join our team in Galway, Ireland as a...

  • Design Quality Assurance Engineer

    2 weeks ago

    Galway, Galway, Ireland Nordson MEDICAL Ireland Limited Full time

    Design Quality Assurance Engineer page is loadedDesign Quality Assurance EngineerApply locations Ireland - Galway time type Full time posted on Posted 30+ Days Ago job requisition id REQ45745Nordson Medical, a global leader in the medical device industry, is seeking an experienced and highly motivated individual to join our team in Galway, Ireland as a...

  • Design Quality Assurance Engineer Ii

    4 weeks ago

    Galway, Galway, Ireland Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the...

  • Design Quality Assurance Engineer II

    4 weeks ago

    Galway, Galway, Ireland Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the...

  • Design Quality Assurance Engineer II

    4 weeks ago

    Galway, Galway, Ireland Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the...

  • Design Quality Assurance Engineer Ii

    1 week ago

    Galway, Galway, Ireland Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the...

  • Senior Design Quality Assurance Engineer

    1 week ago

    Galway, Galway, Ireland Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertSenior Design Quality Assurance EngineerOnsite Location(s):Galway, G, IEDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working...

  • Design Quality Assurance Engineer Ii

    2 weeks ago

    Galway, Galway, Ireland Boston Scientific Full time

    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.With access to the latest tools, information and training,...

  • Senior Design Quality Assurance Engineer

    4 weeks ago

    Galway, Galway, Ireland Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert: Create AlertSenior Design Quality Assurance EngineerOnsite Location(s):Galway, G, IEDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working...