Senior System Verification Engineer, Medical Devices

About the role

We're looking for a Senior System Verification Engineer to join the Verification & Validation team. You'll own the system verification strategy for our instruments, including the ME system where it applies, from concept through industrialization, market release, and supporting controlled device updates. You'll work closely with our hardware team, coordinate with firmware and software teams, and work with the manufacturing team to enable an efficient design transfer.

You'll help shape requirements so they're testable and traceable, define the test methods that verify them, and keep the traceability record that shows every requirement holds up under regulatory scrutiny.

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

Requirements

Must have:

• 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.

Nice to have:

• Familiarity with regulatory frameworks such as FDA and MDR
• Experience developing automated tests
• Experience designing test rigs for reliable and repeatable testing

Why this role matters

Verification is what makes a scan trustworthy. Someone gets told about a mole, a blood pressure reading, a heart signal, and they act on it, so getting it right is the whole job. Here that's a discipline with its own strategy, not a checkbox, and as the senior voice in it you set the method rather than execute someone else's protocol.

You're in the room when requirements are written and sitting alongside optics, electronics, firmware and mechanics design engineers, manufacturing engineers, and clinical colleagues in one Stockholm office, so problems get caught and solved the same day, not months later.