Embedded MedTech Software Verification Engineer

Cubane Solutions AB

Malmö kommun

On-site

SEK 550,000 - 750,000

Full time

7 days ago

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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

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.

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