Design Assurance Expert

4 days ago

Galway, Galway, Ireland beBeeDesign Full time €72,000 - €93,600

We are seeking an experienced Design Assurance Engineer to play a pivotal role in supporting the lifecycle of our commercially released medical device products.

Key Responsibilities
  • Manage design changes, ensuring continued compliance with risk management and design control requirements
  • Support complaint investigations to uphold the safety and effectiveness of our devices
  • Direct involvement in sustaining commercial projects from a Design Assurance perspective, ensuring products comply with global standards
  • Lead and execute product / material design changes for commercially released products, aligning with regulatory and internal quality system requirements
  • Provide DA technical direction / input to process changes for commercially released products, collaborating with R&D and Manufacturing Engineering
Requirements
  • Bachelor's degree in a relevant technical discipline (e.g., Engineering, Science)
  • Minimum 2-3 years of experience in design assurance, quality engineering, or product development in the medical device industry
  • Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and relevant guidance documents
  • Experience with design control and risk management throughout the product lifecycle, including design verification execution, biocompatibility, human factors, and usability
Benefits
  • Opportunity to work independently on larger, moderately complex projects and assignments
  • Dynamic team player who can work effectively and proactively on cross-functional teams
  • Excellent analytical, communication, and documentation skills

  • Design Assurance Expert

    2 weeks ago

    Galway, Galway, Ireland beBeeDesign Full time €60,000 - €80,000

    We are seeking a skilled Design Assurance Engineer to join our team in Galway. This is an exciting opportunity for a talented professional to contribute to the development of high-quality medical devices.Key Responsibilities:Ensure product compliance throughout the product lifecycle.Implement design/material changes aligned with regulatory and internal...

  • Strategic Product Design Assurance Expert

    4 days ago

    Galway, Galway, Ireland beBeeDesign Full time €80,000 - €97,000

    Job PurposeWe are seeking a highly skilled and experienced Product Design Assurance Expert to join our team. As a key member of our cross-functional teams, you will be responsible for ensuring that new products and product changes meet the highest standards of quality, safety, and regulatory compliance.About the RoleYou will maintain expert knowledge of...

  • Design Assurance Professional

    1 week ago

    Galway, Galway, Ireland beBeeDesignAssurance Full time €73,100 - €98,100

    Job Title: Design Assurance Engineer">About the Role:">We are seeking a skilled and experienced Design Assurance Engineer to support 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 supporting complaint...

  • Design Assurance Engineer

    7 days 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...

  • Design Quality Assurance Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeQuality Full time €100,000 - €130,000

    Job Title: Senior Design Assurance Engineer">We are seeking a highly skilled Design Assurance Engineer to join our team. As a key member of our group, you will play a vital role in ensuring the performance and safety of our structural heart devices.In this exciting opportunity, you will lead strategies for risk management, test method validations, design...

  • Senior Quality Assurance Expert

    7 days ago

    Galway, Galway, Ireland beBeeAutomation Full time €95,000 - €110,000

    Senior Quality Assurance ExpertOverviewJob DescriptionWe are seeking a highly skilled Senior Quality Assurance Expert to join our agile squad. As a key member of the team, you will be responsible for ensuring quality is embedded throughout the development lifecycle.You will contribute to the squad's automation strategy, implement test solutions, and support...

  • 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

    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 Specialist

    2 weeks ago

    Galway, Galway, Ireland beBeeDesign Full time €90,000 - €120,000

    Job Overview">As a seasoned design assurance engineer, you will play a pivotal role in ensuring the performance and safety of structural heart devices. You will collaborate with cross-functional teams to develop quality protocols and validate test methods.Key ResponsibilitiesLead strategies for risk management, design verification, and shelf-life...