R&D Software Development

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Join one of the most exciting tech companies in the medical device industry and make a real impact!In 3Shape we work to improve treatment and diagnostics for dental patients by providing innovative scanners and advanced software, tied together in collaborative workflows for the global community of dental professionals worldwide. We are using AI and machine learning methods for analyzing large amounts of medical (dentistry) data – pushing a field which traditionally has looked at 2D images towards 3D scan data.TRIOS Patient Monitoring software product allows the dentist to compare and analyze scans to identify morphological changes or to detect caries. This is used as a diagnostic aid and for evaluation and planning of dental procedures.The positionIn the TRIOS Patient Monitoring team, we are looking for a skilled Design Control Specialist with passion in AI and SW development.As a Design Control Specialist, you play a key role in overseeing and structuring our documentation package; ensuring we have a thorough and efficient documentation that complies to the state of art standards, regulations, and internal processes. You will collaborate closely with the development and testing team to form various technical design documentation including design requirements, specification, defect tracking, verification, and release of AI development.Together with the development team, you will apply your knowledge in planning and performing risk management activities during design and development of device and ensuring it is up to date throughout the device lifecycle. Additionally, you will participate in driving continuous improvement and optimization of design control processes and templates in collaboration with QA and RA team.Your profileWe are looking for candidates with a good understanding of the software product lifecycles. You may have experience from related positions, and you have a relevant education.
  • Knowledge of IEC 62304
  • Experience in working within ISO 13485.
  • Experience in design control and documentation management in a medical device and/or Pharma industry
  • Experience in design input and output documentation
  • ISO 14971 knowledge and Facilitating risk management activity.
  • Experience with cross functional project teamwork and collaboration with R&D, QA, RA, Marketing Usability, and clinical team
  • To have strong cooperation and communication skills
  • To be fluent in English (oral and written)
  • In our search for a new colleague, we always look for people with a cross-disciplinary and open mindset. Through cooperation with program manager, project managers, developers, testers, and Regulatory Affair specialists; you will get an in-depth understanding of all aspects of medical software development and use this to enable our further growth and success.We offer
  • A vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues - we are more than 40 nationalities in our DK based office
  • An attractive healthcare package to keep you fit and well.
  • Breakfast every day, and delicious and healthy lunch cooked by our private chefs.
  • We provide a great social work environment with many optional activities and social clubs, ranging from wine & beer, board games, running to bicycle clubs.
  • Good work/life balance e.g., work from home policy for up to 2 days per week.
  • Attractive offices and R&D lab spaces in downtown Copenhagen close to Kgs. Nytorv, Nyhavn, and the Copenhagen Canals.
  • Purpose: Help improve dental patients on a global scale.
  • Get in touch now!If you are interested in this exciting opportunity, apply already today. We will review the applications continuously. Deadline for application is 1st of March.We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.About us3Shape started with a simple idea - to make 3D scanning better. 3Shape has 2,000+ employees globally, with 500 employees in Copenhagen HQ. With the help of dental professionals and amazing colleagues we are creating award-winning scanning solutions. Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on Facebook and Instagram. Visit our website If you want to read more about our company, recruitment process, or why 3Shape is a great place to work.


    Information og data

    Denne ledige stilling har jobtypen "Softwareudvikler", og befinder sig i kategorien "Informationsteknologi".

    Arbejdsstedet er beliggende i København

    Jobbet er oprettet på vores service den 30.1.2023, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Softwareudvikler
    • København

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