Senior Design Assurance Engineer

2 weeks ago

Galway, Galway, Ireland beBeeDesign Full time €90,000 - €123,456

Key Roles and Responsibilities:

  • Develop new technologies within the quality system, ensuring compliance with Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820, FDA GLP Regulation 21 CFR § 58, FDA Labelling Regulation 21 CFR § 801, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169.
  • Spearhead Design Control, Risk Management, and related systems for new product development technologies.
  • Provide Design Assurance input to R&D project teams, understanding regulatory requirements and incorporating them into projects.
  • Lead specification development and participate in generating Design Input/Output documents.
  • Lead risk management activities for projects and design changes.
  • Design, develop, and validate test methods to support development programs.
  • Develop and maintain design verification and validation plans, protocols, and reports.
  • Support R&D in preparing and delivering Design Reviews and checklists.
  • Support execution of non-clinical studies at third-party facilities.
  • Establish and maintain the Design History File and related documents.
  • Provide QA support for equipment management in R&D.
  • Execute assigned project aspects.
  • Mentor and support Design Assurance engineers.
  • Evaluate readiness for audits and act as a design assurance representative during audits.
  • Address and close non-conformances effectively.
  • Support sustaining activities as assigned.

Requirements:

  • Bachelor's degree in Engineering, Science, or related field.
  • Over 5 years of relevant experience in the medical device or pharmaceutical industry, preferably with Stent and Stent Coating technology.
  • Understanding of ISO 13485, ISO 14971, and FDA QSRs.
  • Familiarity with statistics, validation, and physical testing.
  • Excellent communication and organizational skills, with the ability to present reports clearly and accurately.

  • 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...

  • 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...

  • 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...

  • Design Assurance Director

    2 weeks ago

    Galway, Galway, Ireland beBeeDesignAssurance Full time €80,000 - €100,000

    Design Assurance Program ManagerA Senior Quality Assurance Leader is required to oversee design assurance programs, ensuring accurate documentation and adherence to regulations throughout product development.Lead a team of professionals to ensure the Design History File / Device Master Record is accurately documented.Develop and implement quality systems...

  • Design Quality Assurance Engineer

    4 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 inGalway, Irelandas aDesign...

  • 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 ResponsibilitiesManage design changes, ensuring continued compliance with risk management and design control requirementsSupport complaint investigations to uphold the safety and effectiveness of...

  • 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 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...