Software Verification Engineer

Cubane Solutions AB; Malmö kommun; On-site; SEK 550,000 - 750,000; Full time

Job summary

Cubane Solutions AB in Sweden seeks an experienced embedded software engineer to contribute to MedTech product design and development within a cross-functional project team.

You will define software requirements, verify embedded software, and support manufacturing and QA while ensuring compliance with IEC 62304 and ISO 60601-1 standards.

The ideal candidate has a BSc or MSc in a related field and hands-on RTOS, testing, diagnostics, and risk management experience.

Qualifications

• Experience with embedded software in electromechanical systems.
• Familiarity with RTOS and real-time diagnostics/testing.
• Understanding of software verification in regulated medical environments.
• Knowledge of IEC 62304 and IEC 60601-1 standards.
• Ability to perform risk analysis and support product verification.

Responsibilities

• Contribute to design and development of new MedTech products in a cross-functional team.
• Define software requirements and specifications based on standards, requirements, and risk analysis.
• Plan, execute, document, and report software verification activities.
• Test and evaluate embedded software for functionality, performance, and reliability.
• Integrate and verify software from other engineers.
• Contribute to system-level risk analysis and product verification activities.
• Ensure compliance with FDA, MDR, and ISO requirements.
• Participate in design reviews and maintain project documentation.
• Provide technical support to Manufacturing, QA, and Operations as needed.

Skills

Embedded software

RTOS

Test automation

Diagnostics

Regulated envs

IEC 62304

IEC 60601-1

Risk management

Scripting

Medical standards

Education

BSc or MSc in related field

Job description

Responsibilities

• Contribute to the design and development of new MedTech products as part of a cross-functional project team.
• Define software requirements and specifications based on product standards, requirements, and risk analysis.
• Plan, execute, document, and report software verification activities.
• Test and evaluate embedded software to ensure functionality, performance, reliability, and compliance with applicable standards.
• Integrate and verify software developed by other engineers.
• Contribute to system-level risk analysis and product verification activities.
• Ensure compliance with relevant medical device regulations and standards, including FDA, MDR, and ISO requirements.
• Participate in technical design reviews and maintain required product and project documentation.
• Provide technical support to Manufacturing, Quality Assurance, and Operations when needed.

Requirements

• BSc or MSc in Electrical Engineering, Computer Science, Software Engineering, or a related field.
• Experience with embedded software and testing in electromechanical systems.
• Experience with real-time operating systems (RTOS).
• Experience with test automation and scripting.
• Hands-on experience with diagnostics and debugging of embedded software.
• Understanding of software verification in regulated product environments.
• Knowledge of medical device standards such as IEC 62304 and IEC 60601-1.
• Familiarity with modern software testing strategies, tools, and practices.
• Good understanding of product risk management.