Possible locations
  • Bialystok
  • Bydgoszcz
  • Czestochowa
  • Gdansk
  • Gliwice
  • Katowice
  • Kielce
  • Cracow
  • Lublin
  • Lodz
  • Pila
  • Poznan
  • Rzeszow
  • Szczecin
  • Torun
  • Warsaw
  • Wroclaw
  • Remote work

Join an international team of highly skilled colleagues responsible for driving the maintenance of life-saving medical devices. Become our Design Control Engineer!

Your primary responsibility will be to ensure the Design Control documentation for our products remains up-to-date, of high quality, and compliant with internal procedures and external requirements, such as those set by the EU, FDA, and ISO standards.

Your role

  • Updating and creating device specification documentation for our assigned products, incorporating technical input from colleagues
  • Planning, leading, and executing Engineering Change Orders (ECOs) pertaining to product documentation and labeling
  • Maintaining product labeling specifications
  • Generating labels for the products using provided input data
  • Collaborating with various departments within the organization, including close cooperation with Radiometer Medical in Denmark and Switzerland
  • Preparing and presenting documentation for product registration, as well as during audits and inspections

Your skills
  • Minimum of 2-3 years of relevant experience
  • Bachelor's or Master's degree in Engineering, Pharmacy, or a related field
  • Experience in handling technical documentation, such as specifications, drawings, labeling, instructions, and/or risk management files
  • Fluency in both written and spoken Polish and English
  • Readiness to undertake business trips of up to 10-15 days per year (primarily to Denmark for coordination with colleagues)
  • Analytical mindset with attention to detail
  • Proactivity, self-organization, and capability of meeting deadlines
  • Strong team-oriented mindset with experience in cross-functional collaborations

Optional:

  • Knowledge of design control for medical devices
  • Experience in conducting product verification testing

Job no. 230519-GB6G7

Why Sii

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Fantastic atmosphere

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Attractive benefits package

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