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(Advanced) Project Engineer – Cranial Navigation (R&D) Risk Management(m/w/x)
Managing risk for digital medical workflows, evaluating device-user interactions at medical technology provider with 4000+ hospital installations worldwide. Medical device development experience or risk analysis familiarity required. 6 weeks vacation, December 24th/31st off, bike leasing.
Anforderungen
- Degree in technical/scientific field (biomedical, medical technology, mechanical, electrical, computer science, physics, or comparable)
- Medical device development experience, risk analysis or safety process familiarity
- Strong analytical mindset, understanding complex technical systems
- Interest in systems engineering and safety-driven product development
- Structured working style, high documentation quality standards
- Strong communication skills, interdisciplinary teamwork ability
- Curiosity, willingness to expand medical device risk management expertise
- Affinity for hardware-related topics (surgical platforms/instruments) (plus)
- Experience with risk management standards (e.g., ISO 14971) (beneficial)
- Fluent written and spoken English, German (plus)
Aufgaben
- Serve as central contact for Cranial Navigation R&D risk topics.
- Assist teams with risk identification, analysis, and mitigation.
- Contribute to developing risk strategies for complex systems and interfaces.
- Contribute to executing risk strategies for complex systems and interfaces.
- Evaluate interactions between devices, accessories, workflows, and users.
- Support human factors engineering from a risk perspective.
- Support creation of risk management documentation per regulations.
- Support review of risk management documentation per regulations.
- Support maintenance of risk management documentation per regulations.
- Coordinate use case-driven risk analyses with experts and owners.
- Lead Polarion transition for Cranial Navigation risk portfolio.
- Advise development teams on risk analysis methods.
- Advise development teams on risk analysis best practices.
- Review and harmonize risk documentation across projects.
- Collaborate with R&D, Quality, Regulatory, and Product Management.
- Help align cross-portfolio risk management topics.
- Improve risk management structures, tools, and processes continuously.
- Support maintenance of risk documentation for released products.
- Update risk documentation from Post Market Surveillance.
- Update risk documentation for compatibility changes.
- Ensure compliance with ISO 14971 and related frameworks.
- Contribute to medical device development for Cranial Navigation.
- Contribute to system-level documentation for Cranial Navigation.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- ISO 14971
Benefits
Mehr Urlaubstage
- 30 vacation days
- December 24th and 31st off
Firmenfahrrad
- Bike leasing
Parkplatz & Pendelvorteile
- Parking garage
- Underground bike storage
Gratis oder Vergünstigte Mahlzeiten
- Subsidized company restaurant
Snacks & Getränke
- In-house cafes
Gesundheits- & Fitnessangebote
- Fitness program
- Company gym
Team Events & Ausflüge
- After-work events
- Team events
- Company events
Weiterbildungsangebote
- Training opportunities
- Continuing education opportunities
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(Advanced) Project Engineer – Cranial Navigation (R&D) Risk Management(m/w/x)
Managing risk for digital medical workflows, evaluating device-user interactions at medical technology provider with 4000+ hospital installations worldwide. Medical device development experience or risk analysis familiarity required. 6 weeks vacation, December 24th/31st off, bike leasing.
Anforderungen
- Degree in technical/scientific field (biomedical, medical technology, mechanical, electrical, computer science, physics, or comparable)
- Medical device development experience, risk analysis or safety process familiarity
- Strong analytical mindset, understanding complex technical systems
- Interest in systems engineering and safety-driven product development
- Structured working style, high documentation quality standards
- Strong communication skills, interdisciplinary teamwork ability
- Curiosity, willingness to expand medical device risk management expertise
- Affinity for hardware-related topics (surgical platforms/instruments) (plus)
- Experience with risk management standards (e.g., ISO 14971) (beneficial)
- Fluent written and spoken English, German (plus)
Aufgaben
- Serve as central contact for Cranial Navigation R&D risk topics.
- Assist teams with risk identification, analysis, and mitigation.
- Contribute to developing risk strategies for complex systems and interfaces.
- Contribute to executing risk strategies for complex systems and interfaces.
- Evaluate interactions between devices, accessories, workflows, and users.
- Support human factors engineering from a risk perspective.
- Support creation of risk management documentation per regulations.
- Support review of risk management documentation per regulations.
- Support maintenance of risk management documentation per regulations.
- Coordinate use case-driven risk analyses with experts and owners.
- Lead Polarion transition for Cranial Navigation risk portfolio.
- Advise development teams on risk analysis methods.
- Advise development teams on risk analysis best practices.
- Review and harmonize risk documentation across projects.
- Collaborate with R&D, Quality, Regulatory, and Product Management.
- Help align cross-portfolio risk management topics.
- Improve risk management structures, tools, and processes continuously.
- Support maintenance of risk documentation for released products.
- Update risk documentation from Post Market Surveillance.
- Update risk documentation for compatibility changes.
- Ensure compliance with ISO 14971 and related frameworks.
- Contribute to medical device development for Cranial Navigation.
- Contribute to system-level documentation for Cranial Navigation.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- ISO 14971
Benefits
Mehr Urlaubstage
- 30 vacation days
- December 24th and 31st off
Firmenfahrrad
- Bike leasing
Parkplatz & Pendelvorteile
- Parking garage
- Underground bike storage
Gratis oder Vergünstigte Mahlzeiten
- Subsidized company restaurant
Snacks & Getränke
- In-house cafes
Gesundheits- & Fitnessangebote
- Fitness program
- Company gym
Team Events & Ausflüge
- After-work events
- Team events
- Company events
Weiterbildungsangebote
- Training opportunities
- Continuing education opportunities
Über das Unternehmen
Brainlab
Branche
Healthcare
Beschreibung
The company develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments.
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