(Advanced) Project Engineer Neurosurgical Treatment Planning Systems

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

Remote Work :

No

Employment Type :

Full-time