We are looking for an experienced Principal SaMD Developer with expertise in developing SaMD and DiGA solutions. In this role, you’ll be the expert on the technical requirements that derive from regulatory standards of the DiGA market. As both a hands-on developer and technical leader, you will play a key role in making an impact on our mission to drive innovation in digital health. Acting as a technical expert on DIGA and medical device development standards, you’ll ensure our products remain compliant, secure, and scalable.

Your profile

• A BSc degree in Computer Science, Software Engineering or equivalent.
• 10+ Years Experience in Software Development: Proven experience as a senior developer or tech lead, ideally in a regulated industry (e.g. health tech, medtech, fintech, automotive), with a solid track record in software architecture and development best practices.
• Direct Experience with Medical Device and QMS regulations and standards: Ideally, experience navigating German medtech regulations, working with regulatory bodies, or contributing to product development for the DiGA market or similar.
• Technical proficiency in software development including strong coding skills
• Experience in Software Architecture and System Design
• Familiarity with DiGA, Software life cycle processes (IEC 62304) and Quality management for medical device development (ISO 13485)
• Leadership and Mentorship: Ability to guide and inspire cross-functional teams, fostering a culture of technical excellence and continuous improvement.
• Strong Communication: Clear, proactive communication skills to effectively bridge complex technical concepts with regulatory requirements, while engaging both technical and non-technical stakeholders.
• Analytical Thinking and Problem-Solving: Proficiency in breaking down complex regulatory and technical challenges, identifying practical solutions that align with business goals.
• Adaptability and Proactiveness: Flexibility to adapt to evolving DiGA regulations and a proactive mindset to anticipate future technical and compliance needs.
• Collaboration and Team Orientation: Comfortable working closely within teams, across departments, and in a consulting capacity, fostering a supportive and cohesive team environment.
• Fluent in both German and English (at least level C2)

What you can expect from us

• Technical Expertise and Guidance: Stay on top of technological requirements, industry best practices, and architectural design within the DiGA framework. This includes translating and implementing regulatory requirements into development standards and educating teams on how to comply.
• Hands-on Development: Join one of the core cross-functional development teams to contribute code, model technical best practices, and provide mentorship from within.
• Architecture and Design Leadership: Lead the architectural design for new and existing DiGA products, ensuring solutions are scalable, secure, and sustainable. Drive cross-team technical discussions and promote the adoption of best practices for our software development lifecycle.
• Regulatory Liaison: Act as a point of contact for understanding and integrating DiGA regulatory changes into our technical roadmap. This includes proactive communication with external stakeholders, participating in audits, and ensuring our products align with certification requirements.
• Team Coaching and Development: Coach and mentor developers across the business unit to enhance their technical skills, foster a culture of learning, and drive the adoption of coding and design best practices that align with DiGA requirements.

Why us

• Highly motivated team: Be part of our international team of experts who want to shape the future of healthcare together and improve patient care globally
• Working in cross-functional teams: Our innovative way of working with flat hierarchies allows you to work autonomously and take on end-to-end responsibility. Our organizational structure creates the basis for efficient internal processes that are needed to make a unique contribution to the development of medical product.
• Personal development: Through our feedback-orientated culture and our focus on individual development opportunities, we want to continuously promote your personal growth.
• Attractive entry-level package: Competitive remuneration and the provision of MacBooks and ergonomic office workstations are just as much a matter for us as flexible working hours and unlimited home office options
• Employee benefits: We support your work-life balance and promote your health by subsidizing the Egym Wellpass and Urban Sports Club. You also benefit from our contribution to the Deutschland-Ticket and the company pension scheme
• Relaxed working atmosphere: We take care of your well-being in our office in the heart of Hamburg - both physically and with great offers such as corporate benefits, regular sports activities and company events.