System Engineer

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.

The product

TRIOS Dx offers AI-assisted dental diagnostic aid tools for monitoring oral health conditions and assessing changes in teeth and gingiva. By analyzing a 3D scan TRIOS Dx assists in diagnosing Caries, Tooth Wear, Gingival recession, and Plaque.

TRIOS Dx has recently been made public. It is approved in EU and will soon be deployed to end users. We will therefore enter a phase where we listen to market feedback and improve the product. We will also add new and existing functionality to it over the next many years; and get the product approved in more markets beyond EU.

The position

You will play a key role in ensuring we have thorough and efficient documentation that complies with state-of-the-art standards, regulations, and internal processes.  
In the TRIOS Dx team, we are looking for a skilled System Engineer with passion for AI, Cybersecurity, and SW development process. You will be collaborating with various professionals such as application developers, AI developers, QA, RA, Product Management, and a Clinical Research team of dental professionals. 

Your main tasks include:

• Drive cybersecurity activities to ensure 3Shape software systems are secure and meet the relevant Cybersecurity requirements.
• Manage the software architectural design, interfaces with other systems, and software design specifications, ensuring relevant regulatory and quality requirements are met.
• Collaborate with test engineers to ensure adequate test management and test strategies are in place to demonstrate that 3Shape software systems are safe and effective.
• In collaboration with other functions like RA/QA, ensure that 3Shape software systems meet the relevant regulatory requirements.
• When required, support RA/QA during audits and/or compilation of regulatory submissions.

Additionally, you will participate in continuous improvement and optimization of design control processes and templates in collaboration with QA and RA teams.

Your profile

We 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.

• Background in Engineering/IT/Computer Science or relevant Life Science field.
• Experience in a regulated environment such as medical devices or Pharma.
• Experience in software development, in particular of Medical Software Development Lifecycle, including IEC/EN 62304 and EN 82304.
• Experience in Cybersecurity, preferably for Medical Devices (SaMD/SiMD).
• Experience in authoring and reviewing technical documentation such as software requirements specifications, software architectural design, and software design specifications.
• Knowledge and experience with relevant Medical Devices regulations and standards, such as EU MDR 2017/745, FDA 21 CFR 820.30, and ISO

In our search for a new colleague, we always look for people with a cross-disciplinary and open mindset. Through cooperation with program managers, 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 further growth and success.

We offer

Join one of the most exciting tech companies in the medical device industry and make a real impact. With us, you will be able to work on solutions used by thousands of dental professionals worldwide Moreover, we offer you:

• An opportunity to improve the comfort and treatment of patients by creating the technology of tomorrow.
• A rare opportunity to participate in something radically new, both scientifically and commercially
• An attractive work environment in an informal atmosphere, among best-in-class colleagues
• Competitive employment terms and benefits and a good work-life balance includes remote work for up to 2 days per week.

With us you will be part of the success that 3Shape has created over the past 25 years.

Join 3Shape and make a difference by changing dentistry together with dental professionals across the world by developing innovative solutions that provide excellent patient care in a rapidly growing industry. 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 as soon for this exciting opportunity at one of Denmark's most successful and fastest-growing high-tech companies, as applications will be processed continuously. The deadline for application is 1. September. We look forward to hearing from you.

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.