Software Test Engineer — Verification & Test Automation

Scandinavian Real Heart; Västerås kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

Scandinavian Real Heart in Västerås, Sweden, is seeking a Software Test Engineer to own software verification for a Class III medical device system across embedded firmware, desktop apps and interfaces. You will derive test cases from requirements, write verification protocols and audit-ready reports, and ensure traceability across the design history file.

You will also develop automation in a Python-based framework, integrate tests with GitHub Actions, and help turn regression testing into

Qualifications

• Experience of software testing in medical devices or another comparably regulated industry, such as aerospace, automotive, rail, nuclear, defence or regulated pharma/IVD.
• Understanding of formal design control or safety lifecycles, including the distinction between design verification and design validation.
• Demonstrated experience of requirements-driven test design, including defining objective acceptance criteria, maintaining traceability, and producing verification protocols and reports suitable for audit.
• Experience of building and maintaining automated test suites, including framework design, test data management and test fixtures.
• Experience of version control, change control and formal defect management.
• Strong technical documentation skills, with attention to detail and traceability.
• Strong spoken and written English.

Responsibilities

• Create verification plans, protocols and test cases, select and justify suitable verification methods, define expected results and pass/fail criteria, and maintain traceability from requirement through execution record to result.
• Execute protocols under configuration control, documenting objective evidence, managing deviations and amendments, investigating defects, and writing verification reports.
• Contribute to design reviews and audits by clearly explaining and defending the verification approach.
• On the automation side, design, build and maintain test frameworks and automated suites across unit, integration and system levels.
• This includes developing test harnesses, simulators, stubs and fixtures, as well as supporting hardware-in-the-loop testing where appropriate.
• You will integrate suites into GitHub Actions and help ensure that automated results can serve as reliable verification evidence.

Skills

Regulated software testing

English communication

Requirements-driven testing

Test automation

Documentation

Design control knowledge

Education

Bachelor's degree in engineering or related field

Tools

GitHub Actions

Python

pytest/unittest/Robot Framework

C/C++

NET/C#

IEC 62304

ISO 13485/14971 / EU MDR

Polarion/Jama/Codebeamer/DOORS/Azure DevOps

Hardware-in-the-loop testing

CAN bus / serial protocols

Static analysis / code coverage

FDA inspections / CE submissions

Job description

Would you like to help build the world’s best artificial heart – a technology that could save the lives of people suffering from severe heart failure? Scandinavian Real Heart (Realheart) is a Swedish company developing and manufacturing an artificial heart that mimics the anatomy and function of the human heart. In Västerås, where the company was originally founded, our team is working to take the technology from development to clinical reality. Realheart is listed on Nasdaq First North Growth and has recently announced its goal of being ready for implantation in its first patient in February 2028.

About the role

We are hiring a Software Test Engineer to own software verification for a Class III medical device system spanning embedded firmware, desktop applications and the communication between them. This is a verification role in the regulatory sense: you will derive test cases from approved software requirements, demonstrate objectively that the software meets them, and produce the traceable, auditable evidence that supports the design history file and technical documentation.

You will also develop and maintain the automation that makes verification repeatable. Using a Python-based test framework integrated with CI/CD, you will help turn regression testing from extensive manual work into reliable pipeline-driven execution.

You will analyse software requirements and design specifications for testability, ambiguity and measurable acceptance criteria. You will create verification plans, protocols and test cases, select and justify suitable verification methods, define expected results and pass/fail criteria, and maintain traceability from requirement through execution record to result.

The role also includes executing protocols under configuration control, documenting objective evidence, managing deviations and amendments, investigating defects, and writing verification reports. You will contribute to design reviews and audits by clearly explaining and defending the verification approach.

On the automation side, you will design, build and maintain test frameworks and automated suites across unit, integration and system levels. This includes developing test harnesses, simulators, stubs and fixtures, as well as supporting hardware-in-the-loop testing where appropriate. You will integrate suites into GitHub Actions and help ensure that automated results can serve as reliable verification evidence.

About you

You have experience of working with software testing in a regulated environment and understand the importance of disciplined design control, configuration management and technical documentation. You are comfortable moving between detailed test work and the broader verification argument, and you can distinguish between requirement, implementation and test defects.

To succeed in the role, you combine a rigorous, structured approach with practical engineering judgement. You communicate clearly in English and enjoy collaborating closely with software, firmware, systems and QA/RA colleagues to keep requirements, code and tests aligned.

What we offer

This role offers the opportunity to take ownership of verification in a complex medical device environment and to contribute to both the verification process and the automation infrastructure that supports it. You will work across embedded firmware, desktop applications and connected interfaces, with a clear opportunity to influence templates, tooling and workflows as verification needs evolve. We welcome you to be a central member of our highly skilled and engaged team.

Requirements

• Experience of software testing in medical devices or another comparably regulated industry, such as aerospace, automotive, rail, nuclear, defence or regulated pharma/IVD.
• Understanding of formal design control or safety lifecycles, including the distinction between design verification and design validation.
• Demonstrated experience of requirements-driven test design, including defining objective acceptance criteria, maintaining traceability, and producing verification protocols and reports suitable for audit.
• Experience of building and maintaining automated test suites, including framework design, test data management and test fixtures.
• Experience of version control, change control and formal defect management.
• Strong technical documentation skills, with attention to detail and traceability.
• Strong spoken and written English.

Preferred qualifications

• A Bachelor’s degree or higher in engineering, computer science or a closely related technical field; equivalent demonstrable experience is also valued.
• Working familiarity with .NET/C# and C++, including the ability to read code, understand architecture and create meaningful integration tests.
• Practical Python experience for test automation, using a framework such as pytest, unittest or Robot Framework.
• CI/CD experience, particularly GitHub Actions, including workflow YAML, runners, matrices, secrets, caching and artifacts.
• Experience of IEC 62304 software lifecycle activities, including software safety classification, testing expectations, SOUP management and anomaly evaluation.
• Familiarity with ISO 13485, ISO 14971, EU MDR technical documentation and IEC 62366 usability engineering.
• Experience of ALM or requirements-management tools such as Polarion, Jama, Codebeamer, DOORS or Azure DevOps, including generating trace matrices.
• Experience of embedded or hardware‑adjacent testing, for example serial protocols, CAN bus, instrument control, logic analysers, test rigs or hardware‑in‑the‑loop frameworks.
• Experience of static analysis, code coverage measurement and their role in software verification.
• Experience of FDA inspections, notified body audits, or regulatory submissions such as 510(k), PMA or CE submissions.
• Exposure to cybersecurity testing for connected medical devices.

About the employer – Scandinavian Real Heart

Would you like to help build the world’s best artificial heart – a technology that could save the lives of people suffering from severe heart failure?

Scandinavian Real Heart AB is a Swedish MedTech company that develops a total artificial heart (TAH) for implantation in patients with life‑threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. Only about 8,000 heart transplants occur annually worldwide, and the availability of donated hearts is very limited. Realheart’s mission is to save as many patients who suffer from congestive heart disease as possible through this advanced MedTech solution. Realheart has a an extremely competent and engaged team placed in Västerås in Sweden and is also carried out in very close collaboration with world‑leading heart surgeons and international researchers and engineers. In 2028 the goal is to be able to perform the first implantation in a human patient. Realheart is a public company listed on Nasdaq First North and has recently announced its goal of being ready for implantation in its first patient in February 2028.