Working Student (m/w/d) Quality Management for a Software as a Medical Device

Working Student, Part-time · München

Your mission

Support in improving our Quality Management System (ISO 13485) and software development
processes (IEC 62304) of an innovative software as a medical device for clinical decision support.

On our journey towards certifying our medical device, we recently established and successfully passed
the audit of our Quality Management System (QMS) according to the ISO 13485, IEC 62304, and further
standards for medical device development. This includes, among other things, the comprehension and
documentation of existing product development and maintenance processes.

You are responsible for continuously improving company-wide standard operating procedures for medical device development.
You align with the team to keep processes lean and close to the current practice.
You support our team by reviewing new and existing QMS documents and records for accuracy.

Your profile

Current Bachelor or Master student in any subject, but with an interest in medical device and
software development.
Very good English reading and writing skills. No German skills required.
Prior knowledge of medical device development standards such as ISO 13485 is beneficial but not
required.
Interest in medical device development, quality management, and regulatory topics.
You enjoy defining and working along processes.
You have an eye for detail, you enjoy accurate and meticulous writing.

Why us?

Start date: ASAP
Fixed contract for 6 months, 8-10h/week. Working hours can be scheduled flexibly.
The work can be done partially remote and in our central modern office in the Glockenbach
area, right in the heart of Munich.

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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. Eventually, in the hands of patients, it will guide their therapy towards its personalized goal.

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Your application!

We appreciate your interest in Ebenbuild. Please fill in the following short form. Should you have any difficulties in uploading your files, please contact us by mail via jobs@ebenbuild.com.