Du führst ein agiles Team und stellst sicher, dass die Software-Lebenszyklen eingehalten werden. Zu deinem Arbeitsalltag gehören das Risikomanagement, die Koordination von Entwicklungsaktivitäten und die Erstellung notwendiger Dokumentationen.
Anforderungen
- •Degree in Computer Science
- •Several years of experience leading software teams
- •Experience in Software Development
- •Experience in Software Development under LabVIEW
- •Strong knowledge of IEC 62304
- •Strong knowledge of ISO 14971
- •Strong knowledge of ISO 13485
- •Strong communication skills
- •Team-oriented personality
- •Experience with technical documentation for medical devices
- •High documentation quality standards
- •Well-organized working style
- •Fluent written and spoken German
- •Fluent written and spoken English
Deine Aufgaben
- •Agile Entwicklungsteam mit Scrum leiten
- •Projektmanager für Entwicklungsprojekte sein
- •Einhaltung des Software-Lebenszyklus sicherstellen
- •Risiko-Management-Datei gemäß ISO 14971 erstellen und pflegen
- •Cybersecurity-Best Practices und Vorschriften einhalten
- •Koordination der Produktentwicklung für intraoperative Neuromonitoring
- •Requirements Engineering mit Produktmanagement und Experten durchführen
- •Interne QM-Prozesse zur kontinuierlichen Verbesserung voranbringen
- •Erstellung der Produktdokumentation für Medizinprodukte
- •Kommunikation mit R&D, Herstellern und anderen Abteilungen
Deine Vorteile
Internationale Teamunterstützung
Sinnvolle Arbeit mit Einfluss
30 Urlaubstage plus Feiertage
Flexible Arbeitszeiten
Regelmäßige Team- und Unternehmensveranstaltungen
Internes Fitnessprogramm
Umfassende Schulungs- und Weiterbildungsmöglichkeiten
TOP 100 Innovator und Arbeitgeber 2022
Original Beschreibung
## Job Description
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:
* Leading an agile development team using Scrum principles
* Act as a project manager/lead for ongoing development tasks and new software development projects
* Ensuring compliance with the software lifecycle according to IEC 62304
* 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.
* Ensure compliance with cybersecurity best practices, vulnerability assessments, and regulatory adherence
* Coordination of internal and external product development activities of intraoperative Neuromonitoring
* Requirements Engineering with Product Management, Surgeons and Technical Experts
* Advance internal QM processes within the framework of continuous improvement
* Creation of the medical device product documentation (e.g. technical files, risk management and clinical documentation)
* Communication with R&D departments, manufacturers, and other internal teams (QM, Manufacturing, Purchasing)
## Qualifications
* Degree in Computer Science, Medical Technology, or a related field
* Several years of experience leading software teams, ideally in an agile environment
* Experience in Software Development
* Experience in Software Development under LabVIEW is a plus
* Strong knowledge of IEC 62304, ISO 14971, and ISO 13485 standards
* Strong communication skills and a team-oriented personality
* Experience with technical documentation for medical devices under MDR and/or FDA
* High documentation quality standards
* Well-organized and clearly structured working style
* Fluent written and spoken German and English
## Additional Information
* A mutually-supportive, international team
* Meaningful work with a lasting impact on medical technology
* 30 vacation days, plus December 24th and December 31st
* Flexible working hours
* Regular team, and company events
* Internal company fitness program
* Comprehensive training and continuing education opportunities offered by Brainlab
* TOP 100 innovator and employer of the future 2022