Your mission Support in documenting Standard Operating Procedures (SOPs) for the Quality Management System (QMS) of an innovative software as a medical device that enables precise decision-making of physicians treating severe lung diseases in intensive care and beyond (e.g. COVID-19, ARDS, ILDs). On our journey towards certifying our innovative medical device, we are continuously improving our Quality Management System (QMS) in alignment with ISO 13485, IEC 62304, and other relevant standards for medical device development. As a working student, you will play an active role in shaping and maintaining the processes that ensure the quality and compliance of our products.

• Contributing to the development and revision of Standard Operating Procedures (SOPs), templates, and related documentation for medical device development in accordance with international standards (e.g., ISO 13485, IEC 62304).
• Supporting the maintenance and improvement of our digital QMS by reviewing, structuring, and validating new and existing documents for accuracy, completeness, and consistency.
• Assisting in computer system validation (CSV) and other validation-related tasks to ensure compliance with regulatory requirements.
• Collaborating closely with cross-functional teams (Engineering, Clinical, Regulatory Affairs) to align process documentation with operational workflows.

Your profile We are looking for a structured, motivated student who

• enjoys working with regulated processes and documentation in a fast-growing MedTech environment,
• is currently enrolled in a Bachelor’s or Master’s program, ideally in Management in Healthcare Industry, Medical Device Engineering, Medical Informatics, Computer Science, Medicine, Law, or a related field.
• has very good English reading and writing skills (German is a plus).
• brings interest or first experience in topics such as quality management, regulatory compliance, or medical device development.
• has a structured way of working, an eye for detail, and enjoys precise, accurate writing.
• likes defining, documenting, and improving processes.
• (Nice to have) has prior knowledge of ISO 13485 or similar standards.

Why us?

• Start date: ASAP
• Contract: Fixed-term (6 months), 12–20 hours per week (taking into account the mini-job exemption limit), flexible working hours
• Work model: Hybrid – partially remote and on-site in our modern central office at Holzstraße, Munich
• A chance to gain hands-on experience in quality management for medical devices, working directly with experienced professionals in a collaborative and supportive environment.
• Insights into QMS implementation, regulatory affairs, and software development processes for medical devices.

About Us We are a Munich-based startup building a digital twin platform for respiratory diseases – a monolithic digital toolset that elevates the actions of decision makers in healthcare and life sciences through physics-based simulation, AI, and data science. In the hands of industrial users, it fosters their understanding of pulmonary drug delivery to inform, accelerate and de-risk trial design and execution. In the hands of physicians, it will offer personalized treatment perspectives to improve the odds of survival and recovery in millions of cases of respiratory complication each year, such as Acute Respiratory Distress Syndrome (ARDS). Anywhere at any time.