Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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£56к-66к/год
£53к£66кмедиана£110к
По похожим ролям (50) ~ £66к/год
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У роли чёткая зона ответственности для старшего инженера в медтехе: улучшение продукта, производство и регуляторные задачи; при этом важно учитывать работу на месте и поездки примерно в 25% рабочего времени.
?Частые поездки
Вклад в медтех
Понятная роль
Крупный работодатель
Мэтч & Сопровод
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
Senior Product Engineer (Medical Devices): Managing the transfer and sustaining of surgical guidance and implantable products from R&D through manufacturing, with an accent on product quality, regulatory compliance, and supplier collaboration. Focus on resolving manufacturing and field-performance issues, improving manufacturability and repair processes, and supporting post-market surveillance and regulatory documentation.
Location: Cambridge, UK; UK and international travel required at approximately 25%.
Salary: GBP 55,500–65,500 gross per year, plus pension and insurance benefits.
Company
Endomag, a hirify.global company, develops medical technology for cancer treatment, including surgical guidance and implantable products.
What you will do
Lead sustaining activities for current surgical guidance and implantable products, resolving manufacturing, quality, and field-performance issues with suppliers.
Improve product design for manufacturability, serviceability, and cost-efficiency, including repair processes.
Support change control, product transfers to manufacturing partners, and quality-system documentation.
Collaborate with Quality, Regulatory, Operations, R&D, supply chain, and manufacturing partners.
Participate in supplier audits, validations, technical reviews, and product performance monitoring.
Support post-market surveillance, failure-mode resolution, regulatory submissions, Design History Files, and device manufacturing records.
Requirements
Technical or scientific background in engineering.
Experience in high-tech engineering to exacting standards, ideally in the medical device industry.
Understanding of quality and regulatory requirements, including ISO 13485, MDSAP, MDD/MDR, and FDA 21 CFR Part 820.
Experience working with international manufacturing or supply partners.
Experience with Statistical Process Control techniques for monitoring and improving manufacturing processes.
Excellent problem-solving, written and verbal communication, and attention to detail.
Experience leading process and continuous-improvement projects through successful implementation within set timelines.
Comfort working in a high-compliance, fast-paced environment.
Nice to have
Automation experience.
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 include pension and insurance coverage.
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