Required skills
- V&V
- Design Controls
- IEC 62304
- Medical Device Software Validation
- SaMD
- AI/ML Validation
- Traceability Matrix
- Requirements Engineering
- Risk Management
- Usability Engineering
- Clinical Validation
- English (C2)
Nice to have:Medical ImagingAnatomical DataClinical Workflow SoftwareCardiovascular Applications
Languages: German
Job description
A leading medical technology company is seeking a Senior Design Validation Engineer to lead the validation strategy and execution for their surgical planning software. The role involves defining and managing V&V plans, creating regulatory documentation, and validating AI/ML components.
Project overview
A leading medical technology company in the implant segment is further developing its software for surgical planning. A Senior Design Validation Engineer is sought to be responsible for the validation strategy and to independently manage the validation of the software.
Responsibilities
Absolutely required
Advantageous
- Definition and responsibility for the end-to-end validation strategy for the planning software
- Independent creation and management of V&V plans, protocols, traceability matrices, and reports
- Creation of validation-relevant evidence for regulatory submissions (SaMD)
- Validation of algorithm performance and definition of requirements for validation datasets for AI/ML components
- Evaluation of existing software and documentation, as well as identification of V&V gaps
- Pragmatic remediation of documentation and improvement of quality processes
- Coordination of internal teams during validation execution
- Several years of practical V&V experience for medical device software / SaMD
- Confident handling of IEC 62304 and design control processes for medical devices
- Experience in the validation of AI/ML-based medical devices
- Experience with requirements engineering, risk management, software verification, usability engineering, and clinical validation
- Business-fluent English (C2) as the team and documentation language
- Domain knowledge in medical imaging and anatomical data or models
- Experience with clinical workflow software
- Experience with cardiovascular applications
- Experience with software validation results for regulatory submissions
Project details
- Start: 11/2026
- Duration: 2 Monate+
- Remote: remote
- Location: Deutschland (remote), DE
- Languages: German
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