Senior Systems Engineer

1 week ago


Ballerup, Ballerup Kommune, Denmark Ambu Full time
About the Role

We are seeking an experienced Systems Engineer to join our team at Ambu, a global MedTech company disrupting the endoscopy market. As a key member of our R&D team, you will play a crucial role in developing innovative products that significantly impact patients' lives.

Key Responsibilities
  • Establish and maintain project documentation, ensuring compliance with FDA and ISO requirements.
  • Drive the implementation and documentation of new features in display unit products, ensuring seamless integration and user experience.
  • Secure and manage Non-Conformance Reports (NCRs) and Corrective Action Preventive Action (CAPA) handling for marketed display units.
  • Involvement in process updates and optimizations to ensure efficient and compliant procedures.
  • Collaborate with cross-functional stakeholders to ensure document sets for products and systems meet Ambu procedures and regulatory requirements.
Requirements
  • 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.
  • Team player skills, with a proactive approach to prioritizing, planning, and finalizing tasks.
About Ambu

Ambu is a global company with a strong focus on innovation and fast time-to-market. We develop high-quality medical devices that positively impact patients' lives. Our culture is built on collaboration, creativity, and a passion for making a difference.

What We Offer
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive compensation package.


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