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BRBrainlab

(Advanced) Project Engineer – Cranial Navigation (R&D) Risk Management(m/w/x)

München
Vollzeitmit HomeofficeBerufserfahren

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

  • Englischverhandlungssicher
  • DeutschGrundkenntnisse

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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