1 месяц назад
Senior System Verification Engineer, Software (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior System Verification Engineer, Software (MedTech): Building system-level verification and test automation for regulated health software and SaMD products with an accent on end-to-end testing, requirements traceability, and regulatory compliance. Focus on designing test methods, integrating verification into CI and release pipelines, and producing audit-ready evidence for software that supports clinical decisions.
Location: Hybrid in Stockholm, Sweden
Company
develops preventative healthcare products that combine proprietary technology with direct clinical care to provide personalised, data-driven health insights.
What you will do
- Own and execute system-level verification for SaMD and regulated health software products, including complex interconnected systems.
- Design, implement, and automate regression and end-to-end test methods.
- Build verification automation and infrastructure integrated into development and release pipelines.
- Translate software and system requirements into verification strategies, test methods, and acceptance criteria.
- Maintain traceability matrices, V&V evidence, and automated audit-ready verification reports.
- Collaborate with software, data and AI, firmware, and verification teams to improve product quality and compliance.
Requirements
- 5+ years of system-level verification experience for SaMD or comparable regulated software products.
- Hands-on experience building test automation frameworks, scripts, and tooling for integration, regression, and end-to-end testing.
- Experience integrating automated verification into CI and release pipelines, such as Azure DevOps, GitLab CI, or Jenkins.
- Programming fluency sufficient to read and reason about the code being verified.
- Knowledge of IEC 62304 lifecycle processes, ISO 14971 software risk management, and system integration testing.
- Relevant degree in Software, Computer or Electrical Engineering, Physics, or a similar technical field; clear, structured English for audit documentation.
Nice to have
- Verification experience with machine-learning or algorithm-based software products.
- Experience verifying cloud services and mobile applications end to end.
- Experience contributing to FDA submissions, EU MDR technical files, or Notified Body audits.
- Experience using AI tools and agents, building verification dashboards, or working with embedded verification for hardware products.
Culture & Benefits
- Work in a small, growing, and fast-moving Verification & Validation team.
- Help shape engineering quality, verification strategy, and development practices as the regulated product portfolio scales.
- Contribute to software that supports clinical decisions, including mole, blood pressure, and heart-signal assessments.
- Work across SaMD, health software, and hardware medical devices.
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