System Engineer – Software as a Medical Device (SaMD)

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 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.

About the Role

In the TRIOS Dx team, we are looking for a highly skilled System Engineer to join our R&D team developing next‑generation Software as a Medical Device (SaMD) solution. In this role, you will bridge software engineering, system architecture, clinical requirements, and regulatory expectations to ensure our products are safe, compliant, and impactful for patients and healthcare professionals. You will play a key part in shaping system architecture, defining requirements, and ensuring end‑to‑end traceability and risk control throughout the product lifecycle.

Key Responsibilities

• Define, maintain, and evolve system architecture for SaMD products, ensuring alignment with clinical and business needs.
• Translate user needs, clinical workflows, and product strategy into system‑level requirements and specifications.
• Collaborate with cross‑functional teams — software, QA, data science, design, risk management, and clinical stakeholders — to ensure a cohesive and compliant system design.
• Drive interface definitions, data flow specifications, and subsystem interactions.
• Ensure traceability, verification, and validation across the design control framework.
• Guide engineering teams in applying regulatory expectations such as IEC 62304, ISO 14971, IEC 82304‑1, and relevant cybersecurity guidance.
• Participate in risk analysis, safety architecture development, and hazard mitigation strategies.
• Support planning and execution of system‑level verification and validation activities.
• Contribute to continuous improvement of our system engineering practices and design control processes.

Your profile

We are looking for candidates with a good understanding of the software product lifecycles. You may have experience from related positions and bring a passion for innovation.

Required qualifications

• Bachelor’s or Master’s degree in Software Engineering, Electrical Engineering, Computer Science, Systems Engineering, or related field.
• Experience in complex system architecture or system engineering within regulated industries.
• Strong understanding of software lifecycle management, requirements engineering, and interface design.
• Experience working with risk management and design control principles.
• Ability to structure complex clinical and technical problems into clear, testable system requirements.
• Strong communication skills and comfort working in cross‑functional environments.

Preferred qualifications

• Experience in medical devices, SaMD, digital health, diagnostics, or healthcare technology.
• Familiarity with IEC 62304, ISO 14971, ISO 13485, IEC 82304‑1, or FDA SaMD guidelines.
• Experience with cybersecurity practices and standards (e.g., ISO/IEC 27001, FDA Cybersecurity guidance).
• Knowledge of cloud‑based and/or AI‑enabled medical software architectures.
• Experience with requirements management tools (e.g., Polarion, Jama, DOORS).

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 making 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 including 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 20 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. We look forward to hearing from you.

For more information please reach out to Asger Stoustrup asger.stoustrup@3shape.com

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.

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