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2 дня назад

Product Engineer (Medical Devices)

50 000 - 60 000GBP
Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
UK
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
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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