Brainlab
(Advanced) Project Engineer - Orthopedics(m/w/x)
Full-timeWith HomeofficeExperienced
München
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BRBrainlab
(Advanced) Project Engineer – Cranial Navigation (R&D) Risk Management(m/w/x)
München
Full-timeWith Home OfficeExperienced
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- ISO 14971
Benefits
More Vacation Days
- 30 vacation days
- December 24th and 31st off
Company Bike
- Bike leasing
Parking & Commuter Benefits
- Parking garage
- Underground bike storage
Free or Subsidized Food
- Subsidized company restaurant
Snacks & Drinks
- In-house cafes
Healthcare & Fitness
- Fitness program
- Company gym
Team Events
- After-work events
- Team events
- Company events
Learning & Development
- Training opportunities
- Continuing education opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Brainlab and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BRBrainlab
(Advanced) Project Engineer – Cranial Navigation (R&D) Risk Management(m/w/x)
München
Full-timeWith Home OfficeExperienced
Nejo AI Summary
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.
Requirements
- 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)
Tasks
- 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.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- ISO 14971
Benefits
More Vacation Days
- 30 vacation days
- December 24th and 31st off
Company Bike
- Bike leasing
Parking & Commuter Benefits
- Parking garage
- Underground bike storage
Free or Subsidized Food
- Subsidized company restaurant
Snacks & Drinks
- In-house cafes
Healthcare & Fitness
- Fitness program
- Company gym
Team Events
- After-work events
- Team events
- Company events
Learning & Development
- Training opportunities
- Continuing education opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Brainlab and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Brainlab
Industry
Healthcare
Description
The company develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments.
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