Senior System Verification Engineer, Medical Devices
Hybrid (Stockholm)Full-timePosted 7mo ago
About the role
Senior system verification engineer leading verification strategy for medical device instruments, coordinating across hardware, firmware, software, and manufacturing to ensure testable requirements, regulatory compliance, and smooth design transfer from development to production.
Responsibilities
- Own the system-level verification strategy for our instruments, including the ME system where devices combine, from concept through industrialization and market release
- Develop verification methods, protocols, and workflows for end-to-end and regression testing against a controlled requirement baseline, execute them and sign the report, documenting results, defects, and compliance status to support regulatory submissions, inspections and audits
- Shape product requirements early with cross-functional teams so they're testable and traceable, and keep the traceability matrices that prove every requirement has verification behind it
- Contribute to risk identification and assessment, define adequate risk controls, and verify their implementation
- Apply a risk-based approach to verification strategy that keeps pace with agile development, prioritizing what gets tested and when so problems surface without waiting for a finished build
- Coordinate specialized testing with external test houses (EMC, electrical safety, environmental), owning the interface between our internal requirements and their verification activities
- Work with manufacturing to carry test requirements through design transfer, so quality, safety, and compliance hold as products move from development into manufacturing
- Support controlled device updates with the verification and risk-assessment evidence needed for regulatory sign-off
Qualifications
- 5+ years in system verification of medical devices, including devices governed by the IEC 60601-1 series (for example IEC 60601-1-2 EMC)
- Proven work experience with testing and verification of complex embedded systems (electronics, firmware, software, integrated sensors...)
- Track record designing verification test methods from scratch, defining test setups and acceptance criteria, especially where no existing standard method covers the requirement
- Experience contributing to risk assessment under ISO 14971 as a continuous part of product development
- Comfortable working across hardware, firmware, software, quality, regulatory, manufacturing, and external partner teams
- Bachelor's or Master's degree in engineering or a related technical field
- Documentation another engineer can follow: protocols and reports that hold up without you in the room. Professional English.
Skills
Required:System verification strategyVerification method designRegulatory submission supportRisk assessment (ISO 14971)Cross-functional collaborationDocumentation
Nice to have:Regulatory frameworks familiarity (Nice to have)
Last updated Aug 28, 2026. Interested? Apply on the company site.
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