Systems Engineer

2 months ago


Ballerup, Ballerup Kommune, Denmark Ambu Full time
Transforming Medical Technology

Ambu is a global leader in medical technology, and we're seeking a skilled Systems Engineer to join our team. As a key member of our R&D department, you'll play a crucial role in developing innovative products that impact millions of lives.

Key Responsibilities
  • Establish and maintain project documentation, ensuring compliance with FDA and ISO requirements.
  • Drive the implementation and documentation of new features in our display unit products.
  • Secure and handle NCRs and CAPAs for our marketed display units.
  • Collaborate with cross-functional stakeholders to update and optimize processes, ensuring efficiency and compliance with authority requirements.
  • Work, document, and test according to FDA and ISO standards.
  • Ensure that the document set for each product and system meets Ambu's procedures and expectations for FDA and MDR submissions.
Requirements
  • A background in engineering, with experience in developing high-quality products.
  • Proven experience in systems engineering, including integration, configuration, requirements, and documentation under design control.
  • Knowledge of medical device standards, including IEC.
  • Excellent communication and collaboration skills, with a structured and analytical approach.
  • Ability to work proactively, prioritizing, planning, and finalizing tasks.
About Ambu

Ambu is a global company with a strong focus on innovation and fast time-to-market. We're dedicated to developing products that meet customer needs and positively impact patients' lives. Our headquarters in Ballerup is a hub for innovation, with a great culture and a clear focus on collaboration.

We're looking for a team player who is passionate about medical device engineering and has a strong understanding of systems integration. If you're a skilled engineer with a passion for innovation, we'd love to hear from you.


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