SW Quality Assurance Engineer
At ONWARD we're looking for a SW Quality Assurance Engineer to join our team.
Full-time · Lausanne
This is a unique opportunity for a Software Quality Assurance Engineer to help produce and deliver our breakthrough therapies to people with spinal cord injury on time and with outstanding quality. The Software Quality Assurance Engineer is implementing compliant Quality Assurance processes and records according to which ONWARD medical systems (Class III medical systems consisting of implantable and external medical device components and Software As Medical Devices) are designed and developed, validated and brought to clinical use.
The Software Quality Assurance Engineer is a key player in the team: reviewing, checking, supporting for all activities related to Software design, development and release.
• Ensure regular and proper review of applicable Software standards and guidelines. Ensure training of the engineering team.
• Ensure that the ONWARD Software lifecycle processes are implemented, maintained and up to date.
• Support Software Design and Development activities, identification of level of concern / safety class, testing including test methods, Software verification and validation, sustaining, configuration management and software releases.
• Owner of Design control for Software development.
• Support the requirement management activities. Ensure the requirements are complete and ensure overall traceability and test coverage.
• Support anomalies records and evaluations. Ensure a compliant Bug tracking system. Ensure follow up of the problem resolution.
• Support and track the list of tools used for development. Ensure tools certifications and validation.
• Support the Software supplier’s management. Ensure supplier certification and perform audits
• Contribute on regulatory compliance for Software, Cybersecurity, usability, and human factors analyses per IEC 62366-1 for Active Implantable Devices and Software as Medical Devices
• Support Risk Management, CAPA and device deficiencies activities.
• Contribute to Quality System processes continuous improvement.
• Master’s degree in life sciences or engineering
• 5 to 10 years with relevant industry experience in medical devices, preferably class III (MDR) or AIMD
• Experience with FDA software validation, Cybersecurity and IEC 62304 Software Lifecycle process standard requirements
• Experience with ISO 14971
• Application of usability engineering to medical devices - IEC 62366-1
• Experience with documentation structure compliant with standards and guidelines of the medical device industry
• Skilled in software test and build automation environments and CI/CD pipelines
• Experience with one or more of the following: embedded C, C++, Kotlin, Java and Python languages
• Experience with Jama and Jira a plus
• Strong drive to be precise and thrive for consistency
• High integrity
• Results oriented and hands-on individual who enjoys working in an international, cross-functional environment in a fast-paced and growing company
• Excellent English language proficiency, proficiency in French and/or Dutch language is highly appreciated
Do you want to join our team as our new SW Quality Assurance Engineer? Then we'd love to hear about you!