Approvals Specialist for Electronic Medical Products

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Job description

In 3Shape we always strive to make the best products for the benefits of our users and their patients.

To help us we need a skillful engineer who can take on the responsibility to drive our products across the portfolio to a state of technical compliance and secure the documentation needed. In the job you will have a foot both in the product development projects as well as the product and systems program team, cooperating with both.

Your primary mission:

  • Understanding the technical requirements described by relevant product standards and legislation
  • Help HW developers understand the requirements, and contribute to design discussions
  • Be part of R&D projects from concept to EOL, helping make the right design choices and compromises in our designs that both ensures compliance and results in superior solutions for the customers
  • Interacting with approvals agencies worldwide for product approvals and certifications
  • Gather and present required information for product approvals
  • Cooperate with R&D RA team on technical requirements in worldwide legislation
  • As we believe a strong technical background is an advantage for the position, we are open for discussing additional tasks within R&D which you believe will keep your technical competences sharp. You will work in our R&D headquarter in Copenhagen with 5-20 travel days per year, mostly to our production site in Poland and to our test house partners.

    Your Profile

  • Relevant education in Engineering or Physics
  • Experience with hardware and electronics products
  • Experience with safety and EMC aspects of electronics design
  • Knowledge of certification frameworks, technical standards and test houses are an advantage but willingness and ability to learn fast can do
  • Fluent in English (oral and written)
  • You are a good communicator who can work both independently, with your team, other departments, and external contacts. You are structured, pragmatic and can handle many balls in the air. You can plan and drive tasks and be on the forefront of matters to ensure an effective flow.

    We offer

    3Shape is a world leading technology company headquartered in Copenhagen. Our aim is to lead digital dentistry in the global market creating value for our customers and improving the lives of patients like you and me.

    Working for 3Shape means that you will experience:

  • An informal and inclusive workplace as part of an enthusiastic, skilled, international development team
  • Working on medical applications that will revolutionize dentistry and help improve peoples lives
  • Influence over own tasks, good work-life balance, and a friendly environment with room for fun
  • Headquarters with nice office and lab spaces in central Copenhagen
  • Fresh and delicious lunch and breakfast
  • A good healthcare packages
  • Visit our if you want to read more about our company, mission, or why 3Shape is a great place to work!

    Get in touch now!

    Please do not hesitate to apply for this exciting opportunity at one of Denmarks most successful and fastest-growing high-tech companies, as applications will be processed continuously. We do expect to close our search for this position as soon as possible. Please include education transcripts in your application.

    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 us

    3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,700+ employees globally. With the help of dental professionals and amazing colleagues were creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world.

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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    Approvals Specialist for Electronic Medical Products

    Job description

    In 3Shape we always strive to make the best products for the benefits of our users and their patients.

    To help us we need a skillful engineer who can take on the responsibility to drive our products across the portfolio to a state of technical compliance and secure the documentation needed. In the job you will have a foot both in the product development projects as well as the product and systems program team, cooperating with both.

    Your primary mission:

  • Understanding the technical requirements described by relevant product standards and legislation
  • Help HW developers understand the requirements, and contribute to design discussions
  • Be part of R&D projects from concept to EOL, helping make the right design choices and compromises in our designs that both ensures compliance and results in superior solutions for the customers
  • Interacting with approvals agencies worldwide for product approvals and certifications
  • Gather and present required information for product approvals
  • Cooperate with R&D RA team on technical requirements in worldwide legislation
  • As we believe a strong technical background is an advantage for the position, we are open for discussing additional tasks within R&D which you believe will keep your technical competences sharp. You will work in our R&D headquarter in Copenhagen with 5-20 travel days per year, mostly to our production site in Poland and to our test house partners.

    Your Profile

  • Relevant education in Engineering or Physics
  • Experience with hardware and electronics products
  • Experience with safety and EMC aspects of electronics design
  • Knowledge of certification frameworks, technical standards and test houses are an advantage but willingness and ability to learn fast can do
  • Fluent in English (oral and written)
  • You are a good communicator who can work both independently, with your team, other departments, and external contacts. You are structured, pragmatic and can handle many balls in the air. You can plan and drive tasks and be on the forefront of matters to ensure an effective flow.

    We offer

    3Shape is a world leading technology company headquartered in Copenhagen. Our aim is to lead digital dentistry in the global market creating value for our customers and improving the lives of patients like you and me.

    Working for 3Shape means that you will experience:

  • An informal and inclusive workplace as part of an enthusiastic, skilled, international development team
  • Working on medical applications that will revolutionize dentistry and help improve peoples lives
  • Influence over own tasks, good work-life balance, and a friendly environment with room for fun
  • Headquarters with nice office and lab spaces in central Copenhagen
  • Fresh and delicious lunch and breakfast
  • A good healthcare packages
  • Visit our if you want to read more about our company, mission, or why 3Shape is a great place to work!

    Get in touch now!

    Please do not hesitate to apply for this exciting opportunity at one of Denmarks most successful and fastest-growing high-tech companies, as applications will be processed continuously. We do expect to close our search for this position as soon as possible. Please include education transcripts in your application.

    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 us

    3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,700+ employees globally. With the help of dental professionals and amazing colleagues were creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world.

    Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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