System Developer DK - Copenhagen
3Shape
Do you want to work in a MedTech company within superior dental care? Do you want to work directly in development projects designing new medical devices?
About the team and role
We are looking for a colleague to join our team as System Developer with a focus on design verification and validation. In this position you will work with the development of 3Shape scanner systems, a combination of hardware and software in the medical device domain. The devices are used in the dental industry.
For this role, we are looking for an experienced profile. You will in your daily work be allocated to development projects but will also work on general system development and systems integration tasks such as streamlining processes within the department.
In a normal workday you will collaborate with a variety of different colleagues to develop optical scanner systems.
You will be part of the System Integration group covering design verification and validation, usability, risk management and life cycle management. The team currently has 7 people.
Your Responsibilities
The role is a broad Systems Engineer role with focus on design verification and validation and how these disciplines connects with risk management.
Your responsibilities include writing, or assisting in writing, protocols and reports for design verification and validation activities.
You will also have practical tasks in performing the tests required to verify and validate the design of our products. You will do this in close collaboration with your colleagues in the team as well as the members of the various projects you will be assigned to.
You will work closely with our Risk Manager to ensure traceability from the risk management process to the design verification and validation activities.
Requirements
- Experience working with design control per ISO 13485 and 21 CFR part 820
- Experience with design verification and validation
- Experience with ISO 14971
- Comfortable with the requirements for documenting design control, e.g. writing protocols and reports in accordance with FDA guidelines.
Join us in shaping a company culture that makes Monday mornings worth it.
We are an exciting, visionary, and international place to work. But most of all, we are a diverse group of over 50 different nationalities who all contribute to an awesome company culture. We partake in social clubs, monthly social activities and various in-team activities as well. If that’s not enough, then add on:
- An attractive healthcare package to keep you fit and well.
- Breakfast every day, and a delicious and healthy lunch cooked by our private chefs.
- Good work/life balance e.g., work from home policy for up to 2 days per week.
- A joint purpose: to enable dentists to provide superior dental care to every patient, every time.
Staying true to our values and DEI efforts, we encourage all relevant applicants to apply, and we ask you NOT to add any photos or sensitive information (age, marital status, nationality) during the application process.
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. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.
Locations
DK - Copenhagen
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