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9 дней назад

Principal Design Assurance Engineer (PVH)

81 120 - 121 680€
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Ireland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Principal Design Assurance Engineer (PVH) (Medical Devices): Leading design assurance strategies for peripheral vascular health product development with an accent on risk management, reliability, design verification, shelf-life protocols, and regulatory compliance. Focus on guiding cross-functional teams, qualifying components through PPAP, resolving complex quality issues, and mentoring engineers while meeting FDA, ISO 14971, and ISO 13485 requirements.

Location: Galway, County Galway, Ireland; hybrid with a requirement to work onsite four days per week.

Salary: €81,120–€121,680 per year, plus eligibility for the short-term hirify.global Incentive Plan.

Company

hirify.global is a global healthcare technology company developing medical technologies and therapies used by more than 72 million patients annually across over 150 countries.

What you will do

  • Represent Design Assurance as an extended team member on a PDP project and report indirectly to the project quality lead.
  • Lead risk management, reliability, design verification, and shelf-life protocol and report strategies.
  • Maintain current knowledge of regulatory compliance for product design, development, transfer, and commercialisation.
  • Provide technical guidance on component qualification, including PPAP, and collaborate with internal and external stakeholders.
  • Apply risk management concepts to meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
  • Mentor junior engineers within the project and department.

Requirements

  • NFQ Level 8 degree in Engineering or another relevant discipline with at least 7 years of relevant experience, or an advanced degree with at least 5 years of relevant experience.
  • Advanced breadth and depth of knowledge in the relevant engineering area.
  • Experience in medical device design quality, design assurance, or reliability.
  • Practical knowledge of project management tools and practices.
  • Experience solving complex issues through collaboration with cross-functional groups.
  • Demonstrated critical thinking focused on improved system performance and positive business impact.
  • Excellent written and spoken English, communication skills, and ability to influence.

Nice to have

  • Design for Six Sigma certification, including DRM.

Culture & Benefits

  • Hybrid work arrangement with four days per week onsite in Galway.
  • Competitive salary and flexible benefits package.
  • Eligibility for the hirify.global Incentive Plan short-term incentive.
  • Benefits and compensation resources are designed to support employees across career and life stages.

Hiring process

  • Apply only through official hirify.global channels; legitimate recruiting communications use approved hirify.global platforms and official @hirify.global.com addresses.
  • hirify.global does not request payment or sensitive personal information during early recruitment stages.

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