(Advanced) Project Engineer – Cranial Navigation (R&D) Risk Management
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Join Brainlabs R&D team for Cranial Navigation and help ensure the safety and reliability of cutting-edge technologies used in cranial surgery worldwide.
As a Risk Management Consultant you will play a key role in integrating risk management into the development of complex medical systems. Working closely with multidisciplinary development teams you will support the identification evaluation and mitigation of risks across our cranial navigation portfolio. Your work will combine systems thinking with regulatory and clinical perspectives ensuring that safety considerations are embedded throughout the entire product lifecycle.
You will collaborate with engineers clinical experts and product teams to maintain a holistic view of our navigation ecosystem including platforms instruments and connected this role you will act as a trusted advisor for development teams and contribute to building efficient and robust risk management processes within the organization.
Alongside your risk management responsibilities the role includes additional R&D project engineering tasks depending on your interests and strengths.
Responsibilities as Risk Management Consultant
Risk Management & Systems Engineering
- Act as a central contact for risk-related topics within the Cranial Navigation R&D organization
- Support development teams in identifying analyzing and mitigating risks throughout the medical device lifecycle
- Contribute to the development and execution of risk management strategies for complex medical systems and their interfaces
- Apply systems thinking to evaluate interactions between devices accessories clinical workflows and users
- Support human factors engineering bringing the risk management perspective
- Support the creation review and maintenance of risk management documentation in accordance with regulatory requirements
- Coordinate use casedriven risk analyses together with domain experts and use case owners
- Drive the Polarion transition of Cranial Navigation risk management portfolio from concept to implementation together with domain and clinical experts.
Collaboration & Consulting
- Provide consulting and guidance to development teams on risk analysis approaches and best practices
- Review and support harmonize risk documentation across projects to ensure consistency and high quality standards
- Collaborate with internal stakeholders across R&D Quality Management Regulatory Affairs and Product Management
- Contribute to cross-portfolio alignment of risk management topics with other Brainlab product areas
- Support the continuous improvement of risk management structures tools and documentation processes
Product Lifecycle Support
- Support the maintenance of risk documentation for released products including updates driven by Post Market Surveillance or compatibility changes
- Contribute to ensuring compliance with relevant standards and regulations including ISO 14971 and related frameworks
Responsibilities as (Advanced) Project Engineer
- Medical device development and documentation on system level
- Contribute to medical device development and system-level documentation within the Cranial Navigation product line.
Qualifications :
- Degree in a technical or scientific field such as biomedical engineering medical technology mechanical engineering electrical engineering computer science physics or a comparable discipline
- Experience in medical device development and familiarity with risk analysis or safety-related processes
- Strong analytical mindset and ability to understand complex technical systems and their interactions
- Interest in systems engineering and safety-driven product development
- Structured working style with high standards for documentation quality
- Strong communication skills and ability to collaborate in interdisciplinary teams
- Curiosity and willingness to expand expertise in the field of medical device risk management
- Affinity for hardware-related topics such as surgical platforms or instruments is a plus
- Experience with risk management standards (e.g. ISO 14971) is beneficial
- Fluent written and spoken English German is a 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
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Brainlab revolutionized digital medical technology with the introduction of software for radiosurgery and surgical navigation. Today, Brainlab is an industry leader in digital surgery, radiotherapy and integrated operating rooms.Serving physicians, medical professionals and patients i ... View more
