Principal 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 team is passionate and highly engaged, working together to achieve impactful results.



  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Principal Scientific Software Engineer to lead the development of cutting-edge digital solutions in the pharmaceutical industry. As a key member of our Scientific Software Engineering team, you will be responsible for creating, implementing, and continuously refining a sound solution architecture for our future...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    Job SummaryWe are seeking a highly skilled Principal Scientific Software Engineer to lead the development of cutting-edge digital solutions in the pharmaceutical industry. As a key member of our Scientific Software Engineering department, you will be responsible for creating, implementing, and continuously refining a sound solution architecture for our...


  • 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...


  • 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...


  • Ballerup, Ballerup Kommune, Denmark Schneider Electric Full time

    About the RoleWe are seeking a highly skilled Power System Solution Architect Engineer to join our team at Schneider Electric. As a key member of our organization, you will be responsible for designing and engineering electrical MV power products and solutions for the Danish market.Key ResponsibilitiesConfigure and design MV equipment and products for the DK...


  • Ballerup, Ballerup Kommune, Denmark Ambu Full time

    About the RoleWe 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 ResponsibilitiesEstablish and maintain project documentation, ensuring...

  • Project Manager

    1 week ago


    Ballerup, Ballerup Kommune, Denmark ABB Schweiz AG Full time

    Project Manager - Automation and Control SystemsA challenging opportunity has arisen for a Project Manager to join our team at ABB Schweiz AG. As a Project Manager, you will be responsible for leading and managing projects related to automation and control systems in the pharma industry.Key Responsibilities:Lead and manage projects from initiation to...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleIn this position, you will be responsible for designing, implementing, and refining a robust solution architecture for our research entity registration solutions. You will work closely with an interdisciplinary product team, consisting of colleagues from R&ED, DSI, and global IT, to ensure the successful realization of the solution...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Quality Management System Professional to join our team at Novo Nordisk A/S. As a Quality Management System Professional, you will play a crucial role in driving quality initiatives and projects that will maintain and optimize our high standards of operation.Key ResponsibilitiesLead and implement GMP projects...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleAs a Quality Management System (QMS) Professional, you will play a crucial role in driving quality initiatives and projects that will maintain and optimize our high standards of operation.Key ResponsibilitiesLead and implement GMP projects across ET to improve processes and enhance project management skills.Guide the maintenance, updates, and...


  • Ballerup, Ballerup Kommune, Denmark ABB AS Full time

    About the RoleWe are seeking a highly motivated and experienced Production Excellence Leader to join our Operations team at ABB Robotics. As a key member of our team, you will be responsible for leading the implementation of our Robotics Production System (RPS) in our Swedish factory.Key ResponsibilitiesDevelop and lead the factory's RPS implementation plan,...


  • Ballerup, Ballerup Kommune, Denmark GN Group Full time

    About the RoleWe are seeking an experienced Integration Manager to join our Systems Integration and Verification team in Development Center Hearing, part of the R&D department at GN Group. As an Integration Manager, you will play a crucial role in ensuring technical maturity and facilitating early and iterative system level integration activities during the...

  • Audio DSP Architect

    1 week ago


    Ballerup, Ballerup Kommune, Denmark GN Group Full time

    About the RoleWe are seeking an experienced Audio DSP Software Architect to join our team at GN Group. As an Audio DSP Software Architect, you will play a critical role in designing and developing audio solutions for our innovative Headsets products.Key ResponsibilitiesFacilitate the audio DSP software architecture and development of audio DSP software...


  • Ballerup, Ballerup Kommune, Denmark GN Group Full time

    About the RoleWe are seeking an experienced Integration Manager to join our Systems Integration and Verification team in Development Center Hearing, part of the R&D department at GN Group. As an Integration Manager, you will play a crucial role in ensuring the technical maturity of our advanced hearing aid systems.Key ResponsibilitiesDevelop and implement...


  • Ballerup, Ballerup Kommune, Denmark Siemens AS Full time

    About Siemens Smart InfrastructureSiemens Smart Infrastructure (SI) is a global leader in intelligent infrastructure solutions, shaping the future of urban challenges. As part of Siemens, SI connects energy systems, buildings, and industries to create sustainable and innovative solutions.The Electrification & Automation UnitThe Electrification & Automation...

  • IT Validation Lead

    1 week ago


    Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking an experienced IT Validation Lead to join our team at Novo Nordisk A/S. As an IT Validation Lead, you will play a key role in ensuring the integrity of our IT systems through rigorous validation processes.Key ResponsibilitiesDevelop and execute validation and qualification strategies for GxP and non-GxP Computerized...


  • Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking an experienced Advanced Business Analyst to join our Planning4Future team at Novo Nordisk. As a key member of our team, you will play a crucial role in driving planning-related changes within SAP PP/PI, MM, SD, GBT, and APO.ResponsibilitiesParticipate in design and enhancement activities to ensure compatibility between new and...

  • IT Solution Manager

    1 week ago


    Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking an experienced IT Solution Manager to join our team at Novo Nordisk A/S. As an IT Solution Manager, you will be responsible for the lifecycle management of several critical IT systems used across departments, as well as the implementation of smaller IT projects.Key ResponsibilitiesSupervise and identify new requirements to the...

  • SAP Planning Expert

    7 days ago


    Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled SAP Planning Expert to join our Planning4Future team in Digital, Data & IT Product Supply (DD&IT PS) Supply Chain at Novo Nordisk A/S.Key ResponsibilitiesParticipate in design and enhancement activities, ensuring compatibility between new and existing solutions.Act as the point of contact for infrastructure setup...


  • Ballerup, Ballerup Kommune, Denmark Bloom Full time

    Product Architect to global market leading network companyAre you fascinated by the unleashed compute power in FPGA's and the technological opportunities in IoT, 5G and Cloud? Would you like to have an impact on network products optimizing Cloud datacenter infrastructure and cybersecurity network infrastructure in huge telecom, enterprises and finance...