Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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€81к-122к/год
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Чётко очерченная ведущая роль в крупной medtech-компании даёт серьёзную ответственность в разработке медицинских устройств, но обязательное присутствие в офисе четыре дня в неделю ограничивает гибкость.
Четыре дня в офисе
Понятная зона ответственности
Крупная medtech-компания
Наставничество и лидерство
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
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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