qamanufacturingregulatory complianceproduct engineeringiso 13485spcmedical devices8d problem solving
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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£50к-60к/год
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Обязанности инженера по продукту в регулируемой сфере медтехнологий описаны достаточно четко и связаны с важной работой, хотя предусмотрены поездки примерно в 25% случаев и много документации по соответствию требованиям.
Частые командировки
Понятные обязанности
Вклад в медтех
Пакет льгот
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Product Engineer (Medical Devices): Supporting released medical products and transferring new innovations from R&D to manufacturing partners with an accent on product quality, regulatory compliance, and post-market performance. Focus on investigating emerging failures, improving manufacturing and repair processes, and coordinating supplier audits, validations, and technical documentation.
Location: Cambridge, Cambridgeshire, United Kingdom; UK and international travel required approximately 25%.
Salary: GBP 50,000–60,000 gross per year, plus pension and insurance benefits.
Company
hirify.global, through Endomag, develops innovative medical solutions for cancer treatment and care.
What you will do
Support the transfer of new products from R&D to manufacturing partners while maintaining quality standards.
Investigate emerging product issues, customer feedback, failure modes, and performance trends, working with manufacturers on corrective actions.
Support change control processes and quality-system documentation.
Collaborate with Quality, Regulatory, Operations, R&D, supply chain, and Repair Centre teams.
Develop and improve repair processes and participate in supplier audits, validations, and technical reviews.
Support post-market surveillance and regulatory submissions, including Design History Files, device manufacturing records, and related documentation.
Requirements
Technical or scientific engineering background.
Experience in high-tech engineering to exacting standards.
Strong problem-solving skills, attention to detail, and knowledge of methods such as 8D and 5 Whys.
Excellent written and verbal communication skills.
Ability to work in a high-compliance, fast-paced environment.
Experience with Statistical Process Control techniques for monitoring and improving manufacturing processes.
Nice to have
Experience in the medical device industry.
Understanding of quality and regulatory requirements including ISO 13485, MDSAP, MDD/MDR, and FDA 21 CFR Part 820.
Culture & Benefits
Work at the forefront of life-changing medical technology.
Collaborative and supportive working environment.
Opportunities for personal growth in a fast-growing global company.
Benefits package including pension and insurance coverage.
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