HW/SW Test Engineer (m/f/d)

HW/SW Test Engineer (m/f/d) - software and hardware testing / highly regulated environment / med tech / test planning / Application Lifecycle Management tools / ISTQB / stakeholder intereactions/ English

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking HW/SW Test Engineer (m/f/d).

Background:
The Sub-Chapter Instrument Design Verification is part of R&D Near Patient Care, which is accountable for research and development activities on all systems of the Near Patient Care portfolio from Roche Diagnostics.
We are looking for someone with a technical background, ideally in electronics or medical engineering who brings experience in software and hardware testing for diagnostics instruments.

The perfect candidate has a Bachelor or Master degree in Medical Engineering, Electronics or Informatics and minimum years of experience in software and hardware testing in a highly regulated, preferably med tech environment. The candidate needs to be familiar with test planning and the basics of project management and in cross-functional product development. Experience with software tools and data bases for test management (Application Lifecycle Management tools) and test execution is required.

Tasks & Responsibilities:
• Definition of test cases for diagnostic instruments based on requirements, risk ratings and context; selection of appropriate testing methods
• Execution of tests and/or coordination of external partners for the test execution
• Contribution in the development of testing concepts and -strategies for software and hardware testing on different testing levels
• Review of requirements and specifications
• Planning, execution and documentation of all V&V- activities for system components according to internal Roche guidelines
• Accountability for the test execution incl. standardized documentation (project- and system specific documentation compliant with internal and FDA/IVDR guidelines)
• Collaboration within the interdisciplinary development team
• Status reporting to respective project or product leader.

Must Haves:
• Bachelor or Master degree in Medical Engineering, Electronics or Informatics
• At least 3 years of experience in software and hardware testing in a highly regulated environment
• Experience in a med tech environment is preferred
• Familiar with test planning and the basics of project management
• Experienced in cross-functional product development
• Familiar with software tools and data bases for test management (Application Lifecycle Management tools) and test execution
• ISTQB (International Software Testing Qualifications Board) certification is an advantage
• Networking with internal stakeholders from R&D, production, quality assurance, regulatory affairs, project management
• Fluent in English, German (Basic)

Reference Nr.: 924296SDA
Role: HW/SW Test Engineer (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz (Some Home office possible)
Pensum: 80-100 %
Start: asap ( latest Start Date: 01.09.2025)
Duration: 12++ (longterm project)
Deadline: 14.07.2025

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.