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1 день назад

Senior Product Engineer (Medical Devices)

55 500 - 65 500GBP
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
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
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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