q.beyond AG
Lead AI Governance & Platform Engineer(m/w/x)
Full-timeWith HomeofficeManagement
Oberhausen, Hamburg, Leipzig, Köln, Darmstadt, Ulm, Augsburg
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AMAmbu A/S
Release Engineer / Technical Lead, Software & Electronics(m/w/x)
Augsburg
Full-timeWith Home OfficeExperienced
AI/ML
Nejo AI Summary
Technical direction for AI/ML initiatives in single-use endoscopy, ensuring alignment across software, algorithms, systems, and regulatory requirements. Leading role in bringing regulated AI solutions to market required. Hybrid working model, informal professional work environment.
Requirements
- Engineering skills in global MedTech company
- Leading role in bringing regulated AI solutions
- Part of global Software & Electronics organization
- Ensuring safe, compliant, scalable AI technology release
- Work at intersection of technology, design control, regulation
- Involved in all product lifecycle phases
- Combine deep technical understanding with design control
- Driving technical clarity, risk awareness, release readiness
- Educational background in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or similar
- Solid experience with software-intensive medical devices or regulated products
- Strong hands-on experience with design control, requirements management, risk management, traceability
- Proven ability to apply IEC 62304, ISO 14971, MDR / FDA guidance
- Experience working with or close to AI/ML development
- Understanding of AI-specific challenges in regulated products
- Experience with system integration and complex hardware/software interactions
- Strong analytical skills and ability to balance technical depth with product decisions
- Ability to work independently, structure complex work, proactively drive progress
- Excellent collaboration and communication skills in global, cross-functional environment
- Experience as software or algorithm developer is advantageous
- Fluent communication in English, written and spoken
Tasks
- Provide technical direction for AI/ML initiatives
- Ensure alignment across software, algorithms, systems, and regulatory requirements
- Drive technical maturation, integration, and release of AI-powered software features
- Maintain design control deliverables
- Define and trace requirements
- Create system and software documentation
- Translate clinical, business, and regulatory needs into technical requirements
- Ensure compliance with standards and regulations
- Establish technical and documentation overview
- Support regulatory submissions and audits
- Drive lifecycle management activities
- Manage design changes, product updates, NCRs, and CAPAs
- Collaborate with project, release, and product managers
- Work with AI/ML developers, testers, UX, and external partners
- Contribute to process and template improvements
- Support continuous improvement in AI and software development
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
Tools & Technologies
- AI
- Machine Learning
- IEC 62304
- ISO 14971
- MDR
- FDA
Benefits
Flexible Working
- Hybrid working model
Informal Culture
- Informal professional work environment
Learning & Development
- Personal development opportunities
- Professional development opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ambu A/S 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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AMAmbu A/S
Release Engineer / Technical Lead, Software & Electronics(m/w/x)
Augsburg
Full-timeWith Home OfficeExperienced
AI/ML
Nejo AI Summary
Technical direction for AI/ML initiatives in single-use endoscopy, ensuring alignment across software, algorithms, systems, and regulatory requirements. Leading role in bringing regulated AI solutions to market required. Hybrid working model, informal professional work environment.
Requirements
- Engineering skills in global MedTech company
- Leading role in bringing regulated AI solutions
- Part of global Software & Electronics organization
- Ensuring safe, compliant, scalable AI technology release
- Work at intersection of technology, design control, regulation
- Involved in all product lifecycle phases
- Combine deep technical understanding with design control
- Driving technical clarity, risk awareness, release readiness
- Educational background in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or similar
- Solid experience with software-intensive medical devices or regulated products
- Strong hands-on experience with design control, requirements management, risk management, traceability
- Proven ability to apply IEC 62304, ISO 14971, MDR / FDA guidance
- Experience working with or close to AI/ML development
- Understanding of AI-specific challenges in regulated products
- Experience with system integration and complex hardware/software interactions
- Strong analytical skills and ability to balance technical depth with product decisions
- Ability to work independently, structure complex work, proactively drive progress
- Excellent collaboration and communication skills in global, cross-functional environment
- Experience as software or algorithm developer is advantageous
- Fluent communication in English, written and spoken
Tasks
- Provide technical direction for AI/ML initiatives
- Ensure alignment across software, algorithms, systems, and regulatory requirements
- Drive technical maturation, integration, and release of AI-powered software features
- Maintain design control deliverables
- Define and trace requirements
- Create system and software documentation
- Translate clinical, business, and regulatory needs into technical requirements
- Ensure compliance with standards and regulations
- Establish technical and documentation overview
- Support regulatory submissions and audits
- Drive lifecycle management activities
- Manage design changes, product updates, NCRs, and CAPAs
- Collaborate with project, release, and product managers
- Work with AI/ML developers, testers, UX, and external partners
- Contribute to process and template improvements
- Support continuous improvement in AI and software development
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
Tools & Technologies
- AI
- Machine Learning
- IEC 62304
- ISO 14971
- MDR
- FDA
Benefits
Flexible Working
- Hybrid working model
Informal Culture
- Informal professional work environment
Learning & Development
- Personal development opportunities
- Professional development opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ambu A/S 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Ambu A/S
Industry
Healthcare
Description
Ambu ist ein international führendes Medizintechnikunternehmen, das sich auf die Verbesserung der Patientensicherheit und Effizienz im klinischen Alltag konzentriert.
Not a perfect match?
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