Software Team Lead / Project Manager (Medical Device)

As a Software Team Lead / Project Manager in the R&D department, you will be part of an interdisciplinary and highly skilled team. You will be responsible to lead a team of software developers for intraoperative neuromonitoring and related applications.

Your responsibilities include supporting ongoing software development projects, as well as planning, coordinating, and executing technical software projects within the company. You will work closely with various departments to ensure that projects are completed on time and meet technical requirements.

Typical areas of your responsibility are:

1. Leading an agile development team using Scrum principles.
2. Act as a project manager/lead for ongoing development tasks and new software development projects.
3. Ensuring compliance with the software lifecycle according to IEC 62304.
4. Responsibility for creating and maintaining the Risk Management File in accordance with ISO 14971, including risk analysis, evaluation, and mitigation strategies for the software-related requirements.
5. Ensure compliance with cybersecurity best practices, vulnerability assessments, and regulatory adherence.
6. Coordination of internal and external product development activities of intraoperative neuromonitoring.
7. Requirements Engineering with Product Management, Surgeons, and Technical Experts.
8. Advance internal QM processes within the framework of continuous improvement.
9. Creation of the medical device product documentation (e.g., technical files, risk management, and clinical documentation).
10. Communication with R&D departments, manufacturers, and other internal teams (QM, Manufacturing, Purchasing).

Qualifications:

1. Degree in Computer Science, Medical Technology, or a related field.
2. Several years of experience leading software teams, ideally in an agile environment.
3. Experience in Software Development.
4. Experience in Software Development under LabVIEW is a plus.
5. Strong knowledge of IEC 62304, ISO 14971, and ISO 13485 standards.
6. Strong communication skills and a team-oriented personality.
7. Experience with technical documentation for medical devices under MDR and/or FDA.
8. High documentation quality standards.
9. Well-organized and clearly structured working style.
10. Fluent written and spoken German and English.

Additional Information:

1. A mutually-supportive, international team.
2. Meaningful work with a lasting impact on medical technology.
3. 30 vacation days, plus December 24th and December 31st.
4. Flexible working hours.
5. Regular team and company events.
6. Internal company fitness program.
7. Comprehensive training and continuing education opportunities offered by Brainlab.
8. Langer Medical is TOP 100 Innovator 2022 and Employer of the Future 2022 and 2024.