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11 дней назад

Technical Project Manager (Medical Devices)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Norway
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Текст:
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TL;DR
Technical Project Manager (Medical Devices): Leading multidisciplinary medical device development across hardware, embedded software, cloud services, and analytics from approved requirements through manufacturing readiness with an accent on system architecture, regulatory evidence, and design transfer. Focus on coordinating ISO 13485 development, MDR CE marking, V&V, outsourced partners, and integration across distributed engineering teams.

Location: Oslo Science Park (Forskningsparken), Oslo, Norway; primarily on-site with some flexibility and travel to other sites.

Company

hirify.global develops LYNG, a contactless monitoring mat for hospitals, nursing homes, and home care, combining medical device engineering, software, and clinical understanding.

What you will do

  • Lead project scope, milestones, resources, budget, dependencies, technical risks, and R&D capacity.
  • Drive system architecture, multidisciplinary integration, and traceability from product requirements to test evidence across hardware, embedded software, cloud, and analytics.
  • Manage design control, risk management, design reviews, engineering changes, configuration control, and V&V.
  • Deliver engineering evidence for MDR CE marking and collaborate with QARA on regulatory approvals.
  • Lead design transfer with Operations, including manufacturing documentation, test methods, software releases, and readiness acceptance.
  • Coordinate developers across geographical sites and manage outsourced development partners through work packages, controlled interfaces, and technical acceptance.

Requirements

  • 8+ years of experience in similar roles.
  • Documented successful completion of ISO 13485-governed development projects for physical products with integrated software, including V&V and design transfer.
  • Hands-on CE marking experience under EU MDR 2017/745, including technical documentation, conformity assessment support, and QARA collaboration.
  • Strong technical project management covering scope, schedule, budget, resources, risks, and outsourced partners.
  • Strong system architecture and systems engineering across hardware, embedded software, cloud, and analytics, including interface control and integration.
  • Practical competence in design control, traceability, medical device risk management, configuration and change control, and cybersecurity.
  • Relevant technical degree or equivalent documented professional competence.
  • Spoken and written English at A-level, or equivalent documented language skills, is required.

Nice to have

  • Spoken and written Norwegian at a similar level.
  • Formal project management qualification.
  • Experience in technology strategy, overall R&D leadership, and people management.
  • Relevant Engineering MSc.

Culture & Benefits

  • Join at an early stage as LYNG moves from clinical pilots toward commercial scale.
  • Work in a small, dedicated team with a flat Scandinavian structure and direct influence on the product and R&D delivery.
  • Collaborate across engineering, quality, clinical, manufacturing, Product Management, Operations, and the management team.
  • Work primarily on-site with some flexibility and travel to other sites.

Hiring process

  • Submit a CV and brief, non-confidential examples of medical device projects delivered through the application form.
  • Describe your role, technical challenges, outcomes, ISO 13485 development experience, MDR CE marking contribution, architecture responsibilities, design transfer experience, and English and Norwegian language skills.
  • Application deadline: 16 November 2026.

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