Medical Device Test Engineer: Verification & Automation

Scandinavian Real Heart

Västerås kommun

Sur place

SEK 700 000 - 900 000

Plein temps

14 jours+

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Résumé du poste

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.

Responsabilités

  • 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.

Connaissances

Regulated software testing
English communication
Requirements-driven testing
Test automation
Documentation
Design control knowledge

Formation

Bachelor's degree in engineering or related field

Outils

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

Description du poste

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

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