Approvals Specialist for Electronic Medical Devices
Join 3Shape as Approvals Specialist!
Do you know what it takes to bring an electronic medical device to market by ensuring its technical compliance in an efficient and smart way? Then please read on!
Job description
In 3Shape we always strive to make the best products for the benefit 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 work with multiple projects in hardware development across all lifecycle phases, from concept to end-of-life and with relevant functions across the organization.
Your primary mission:
- Understand the technical requirements in product standards and legislation in corporation with RA and development teams
- Help our engineers design the right solutions that both ensure compliance and results in superior solutions for the customers
- Interact with approvals agencies worldwide for product approvals and certifications, defining test scope and aid in coordinating test execution
- Gather required information for product approvals and keep it up to date in our technical files
- Be part of our risk management group ensuring technical compliance is evaluated and help formulate and review labelling and instructions for users
We believe a technical background is an advantage for the position. You will work in our R&D headquarter in Copenhagen with approximately 5-15 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, EMC and Radio/wireless aspects of electronics design
- Knowledge of certification frameworks, technical standards and test houses are a big 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 other departments, and external contacts. You are structured, pragmatic and can handle many balls in the air. You can plan and drive tasks and like keeping relevant information at hand in an easy structured format.
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 website 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 Denmark’s most successful and fastest-growing high-tech companies. Applications will be processed continuously, and position closed when the right candidate is found.
Please include education transcripts in your application.
- Department
- R&D Scanner Development
- Role
- Intraoral Scanners
- Locations
- DK - Copenhagen
DK - Copenhagen
Our biggest assets are our people and culture 💗
Life at 3Shape is great! We bring passion and talent to work every day to innovate for superior patient care. 3Shape is built on a culture of thinking differently and being innovative when solving challenges. We embrace new ways to exchange ideas with colleagues across departments and think and work in an agile way. Experience the everyday #lifeat3Shape across the globe on Facebook.
About 3Shape
3Shape develops 3D scanners and software solutions that enable dental and hearing professionals to treat more people, more effectively and with superior care. We are a global market-leading provider of dental and audio technology for laboratories and clinics.
Our growing talent pool of over 2,000 employees spans 50+ nationalities and is energized by knowing that together, we contribute to a better world.
Two graduate students founded 3Shape in Denmark’s capital, Copenhagen in the year 2000. Today, 3Shape employees serve customers in over 100 countries. As a privately-owned company, decisions are made fast, and we remain agile.
3Shape is headquartered in Copenhagen, with development teams in Denmark, Ukraine and Macedonia with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.
Approvals Specialist for Electronic Medical Devices
Join 3Shape as Approvals Specialist!
Loading application form
Already working at 3Shape?
Let’s recruit together and find your next colleague.