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(Advanced) Project Engineer - Neurosurgical Treatment Planning Systems

Brainlab -
München

Direkt bewerben

Details zur Stelle

Vollzeit

Leistungen

Firmenfahrrad-Leasing
Firmenevents
Flexible Arbeitszeiten

Qualifikationen

Informatik
Kommunikationsfähigkeit
Python

Vollständige Stellenbeschreibung

Company Description

At the forefront of health technology for over 35 years, Munich-based Brainlab digitizes medical workflows, from diagnosis to therapy, to offer clinicians and patients better treatment possibilities. Our innovative digital ecosystem forms the basis for modern healthcare technology in 4000 hospitals in 120 countries.

Our key to success is our creative, talented and hard-working team, which consists of around 2000 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.

Job Description

To strengthen our development team, we are looking for a dedicated (Advanced) Project Engineer for the development of our treatment planning medical device systems. The focus of this position is on medical device documentation, system validation, risk management and regulatory compliance throughout the entire development process & product lifecycle incl. post market surveillance.

Your responsibilities include:

Leading regulatory and quality-related activities within development projects to ensure compliance with applicable standards and regulations (e.g., MDR, ISO 13485, IEC 62304, IEC 62366, ISO 14971)
Managing and driving verification and validation (V&V) activities, ensuring completeness, traceability, and audit readiness
Ownership for technical documentation, including design history files, risk management files and clinical evaluation
Establishing and maintaining documentation processes and templates aligned with internal and external requirements
Acting as a subject matter expert for regulatory and documentation topics within cross-functional project teams
Coordination with Regulatory Affairs and Quality Assurance to support submissions, audits, and inspections
Management of post market surveillance (PMS) activities
Ensuring end-to-end traceability from requirements through design, verification, validation, and release
Driving continuous improvement of development and documentation processes, including tool chains and workflows
Collaborating closely with internal teams, clinical partners, and external stakeholders

Qualifications

You are an independent and enthusiastic individual who enjoys working in a dynamic, international and cross-functional team and you:

Have graduated from academic studies like sciences, engineering, computer science or mathematics
Have several years of experience in medical device development, ideally in software (SaMD) or complex systems
Have strong experience in FDA or MDR compliant documentation (e.g. ISO 14971, IEC 62304, ISO 13485) and post market surveillance of medical devices
Are a team worker, fluent verbal and written English communication skills, German knowledge is a plus
Have strong stakeholder management and communication skills
Have a detail-oriented, analytical mindset with an ability to take ownership and work independently
Have well-organized and clearly structured work style and a “can do” mentality with a strong focus on quality and compliance
Have first practical experience in using e.g. Python or other tools for scripting, data analysis, or usage of AI tools for task or process automation
Have experience in handling of radiological medical images like MRI/CT in DICOM format
Are fluent in English; German is a strong plus

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 as well as hybrid work model within Germany
Bike leasing via cooperation partner "BikeLeasing"
Parking garage and safe underground bike storage
Award-winning subsidized company restaurant and in-house cafes
Variety-rich fitness program in our ultra-modern 360m2 company gym
Regular after work, team, and company events
Comprehensive training and continuing education opportunities

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary.

Contact person: Elisabeth Karro

Direkt bewerben

Erweiterte Suche

engineer | focus data science & data management Jobs in münchen, by

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Ich möchte aktuelle Job-E-Mails für Stellen als engineer | focus data science & data management in münchen, by erhalten

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