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Systems Engineer for Medical Technology Innovations

2 months ago

Ballerup, Ballerup Kommune, Denmark Ambu Full time

Are you eager to leverage your expertise in a leading MedTech organization that is transforming the endoscopy sector? Do you aspire to contribute to the creation of groundbreaking products that profoundly influence patient care? If you are prepared to elevate systems engineering at Ambu, this opportunity may be for you.

In this dynamic role, you will play a vital part in Research and Development as a Systems Engineer. Join us in a journey towards a fulfilling career.

A position that makes a difference

You will engage in the development of features for our display unit products, ensuring the ongoing success of Ambu and enhancing the experience for our end users. If you possess the skills to navigate systems and integration across various technologies and are passionate about expediting the introduction of new innovations to the market, Ambu could be the ideal workplace for you.

As a Systems Engineer, your involvement will span all stages of the product development lifecycle—from initial design concepts to product validation and ongoing support, including managing design modifications.

We expect you to work autonomously while demonstrating strong organizational and structural skills, ensuring effective follow-up with both internal and external stakeholders to maintain project momentum.

You will be instrumental in our projects, responsible for creating essential product documentation such as requirements, design outputs, and submission materials. Additionally, you will help define new features for our users while ensuring our internal processes remain current to support the integration of new technologies into our products. Your collaborative spirit will shine as you work within project teams, identifying practical solutions to technical challenges and promoting appropriate documentation practices among stakeholders.

Key Responsibilities

  • Establish and maintain comprehensive project documentation.
  • Drive the implementation and documentation of new features in Display Unit Products.
  • Oversee Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs) for our marketed Display Units.
  • Participate in process updates and optimizations to ensure our procedures are efficient and compliant with regulatory requirements.
  • Work, document, and test in accordance with FDA and ISO standards.
  • Collaborate with cross-functional stakeholders to ensure that the documentation for specific products and systems adheres to Ambu's procedures and meets expectations for regulatory submissions.

Your role will involve extensive collaboration with Ambu's global teams, engaging with all departments involved in product development projects, as well as external technical partners and suppliers.

Embrace our innovative culture

At our headquarters, where we design many of our new medical devices, we foster a vibrant innovation culture with a strong emphasis on rapid market entry. We are committed to developing the right products to meet customer and user needs while positively impacting patient outcomes. This commitment demands a deep understanding of medical device development and the integration of complex systems.

You will report to the Systems Engineering Manager, Software & Electronics, and become part of a team of four dedicated and engaged engineering professionals who work collaboratively to achieve impactful results.

Your qualifications as a medical device engineer

Our commitment to your success is paramount. To support this, we envision that you possess:

  • A solid engineering background with an understanding of high-quality product development.
  • Proven experience in systems engineering, including integration, configuration, requirements, and documentation under design control.
  • Familiarity with medical device standards.
  • Interest and experience with IEC standards.
  • Strong communication and collaboration skills.
  • A team-oriented mindset, with a structured and analytical approach to prioritizing, planning, and completing tasks.

As Ambu operates on a global scale, proficiency in English is essential for effective communication.

Application Process

We encourage interested candidates to apply, as we will be conducting interviews on an ongoing basis.

Your application will be handled with the utmost confidentiality.