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Systems Engineer for Medical Technology

2 months ago


Ballerup, Ballerup Kommune, Denmark Ambu Full time

Are you eager to leverage your expertise within a global MedTech organization that is transforming the endoscopy sector? Do you aspire to contribute to the creation of groundbreaking products that have a profound effect on patients' well-being? If you are prepared to elevate systems engineering at Ambu, this opportunity may be the right fit for you.

In this dynamic role, you will play a vital part in R&D as a Systems Engineer. Join us in a career that is #ForeverForward.

A position that influences countless lives

You will engage in the development of features for our display unit products, ensuring the ongoing success of Ambu and benefiting our end users. If you possess the skills to navigate systems and integration across various technologies and are passionate about facilitating the swift introduction of new technologies 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 concept design through to product validation and ongoing product support, including managing design modifications.

We expect you to work autonomously and demonstrate strong organizational and structural skills, effectively coordinating with both internal and external stakeholders to ensure progress aligns with established plans.

You will be instrumental in our projects, responsible for creating essential product documentation such as requirements, design outputs, and submission materials. Additionally, you will contribute to defining new features for our users while ensuring our internal processes remain current to support the integration of new technologies into our products. You thrive in project teams and can identify practical solutions to technical challenges while promoting appropriate documentation standards to stakeholders.

Key Responsibilities

  • Establish and maintain comprehensive project documentation.
  • Drive the implementation and documentation of new features in Display Unit Products.
  • Manage 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 set for specific products and systems adheres to Ambu's procedures and meets the expectations for FDA and MDR submissions.

Your role will involve a broad network of contacts, collaborating with Ambu's global organization, all departments engaged in product development projects, as well as external technical partners and suppliers.

Experience Our Culture

At our headquarters, where we develop many of our innovative medical devices, we foster a strong culture of innovation with a clear emphasis on rapid time to market. We are committed to creating the right products to meet customer and user needs, ultimately making a positive impact on patients' lives. 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 join a team of four dedicated and highly engaged engineering professionals who embody the principles of #TakeCharge and #TeamUp to achieve meaningful results.

Qualifications

To set you up for success, we envision that you possess:

  • A solid engineering background with an understanding of what it takes to produce high-quality products.
  • Proven experience in systems engineering, including integration, configuration, requirements, and documentation under design control.
  • Familiarity with standards applicable to medical devices.
  • Interest and experience with IEC standards.
  • Excellent communication and collaboration abilities.
  • Strong team player skills, with a structured and analytical approach to prioritizing, planning, and completing tasks.

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

Application Process

We encourage interested candidates to apply without hesitation. Your application will be handled with confidentiality.