Software Team Lead / Project Manager (Medical Device)

Langer Medical, a Brainlab Company; Waldkirch; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Software Team Lead / Projektmanager, der ein hochqualifiziertes Team leitet und bedeutende Softwareprojekte im Bereich der intraoperativen Neuromonitoring-Technologie verantwortet. Diese Rolle erfordert die Anwendung agiler Methoden und die Einhaltung strenger Normen, um sicherzustellen, dass Produkte den höchsten Qualitätsstandards entsprechen. Sie werden eng mit verschiedenen Abteilungen zusammenarbeiten, um sicherzustellen, dass Projekte termingerecht und gemäß den technischen Anforderungen abgeschlossen werden. Das Unternehmen bietet ein unterstützendes internationales Team und sinnvolle Arbeit, die einen bleibenden Einfluss auf die Medizintechnologie hat.

Leistungen

30 Urlaubstage

Flexible Arbeitszeiten

Regelmäßige Team- und Unternehmensveranstaltungen

Interne Fitnessprogramme

Umfassende Schulungs- und Weiterbildungsmöglichkeiten

Qualifikationen

• Mehrjährige Erfahrung in der Führung von Softwareteams, idealerweise in einem agilen Umfeld.
• Kenntnisse in IEC 62304, ISO 14971 und ISO 13485 sind erforderlich.

Aufgaben

• Leitung eines agilen Entwicklungsteams unter Verwendung von Scrum-Prinzipien.
• Koordination interner und externer Produktentwicklungsaktivitäten.

Kenntnisse

Führung von Softwareteams

Agile Entwicklung

Kommunikationsfähigkeiten

Technische Dokumentation

Requirements Engineering

Risikomanagement

Softwareentwicklung

Kenntnisse in LabVIEW

Kenntnisse der Normen IEC 62304, ISO 14971, ISO 13485

Fließend in Deutsch und Englisch

Ausbildung

Abschluss in Informatik

Abschluss in Medizintechnik

Abschluss in verwandtem Bereich

Tools

LabVIEW

Jobbeschreibung

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.