Company: TWIICE SA

Job Title: Software Verification Engineer

Department: Engineering/Quality Assurance

Location: 1020 Renens

Type: Full-Time

Start date: December 1, 2024

|| Who we are

Our company develops powered exoskeletons to help those with lower-limb impairment walk again and reconnect with their community. As a world leader in the field, we set records of performance and keep pushing the boundaries of technology for the benefit of human beings. Fundamentally user-centered, we believe that life should be accessible to all. We have therefore developed the world's lightest exoskeleton of its kind and work everyday towards ever more inclusion through disruptive technology.

|| Position

The Software Verification Engineer will be responsible for verifying and validating software used in medical devices, including unit testing and preparation of documentation for FDA submissions. This role is crucial for ensuring that our software meets all regulatory requirements and performs reliably in a medical environment.

Responsibilities and Duties

• Software Verification:
  • Develop and execute software verification plans and test cases to ensure software meets design specifications and regulatory requirements.
  • Perform unit testing, integration testing, and system testing of software components.
  • Automate test cases and create test scripts to improve testing efficiency and coverage.
• Regulatory Documentation:
  • Prepare and maintain detailed verification documentation required for FDA submissions, including test protocols, reports, and validation records.
  • Ensure documentation complies with FDA regulations (e.g., 21 CFR Part 820, IEC 62304) and industry standards.
  • Assist in the preparation of regulatory filings and support interactions with regulatory agencies.
• Quality Assurance:
  • Ensure all verification activities adhere to quality management system (QMS) requirements and best practices.
  • Identify, document, and track software defects, and collaborate with development teams to resolve issues.
  • Conduct risk assessments and contribute to risk management activities related to software.
• Software Architecture Maintenance:
  • Maintain and improve the software architecture to support scalability, performance, and reliability.
  • Ensure the architecture accommodates new features and technologies while maintaining system integrity.
  • Collaborate with software developers to align architecture with development practices and goals.
  • Document architectural decisions, designs, and any changes to ensure clarity and consistency.
• Collaboration and Support:
  • Work closely with developpment and quality assurance teams, and regulatory affairs to ensure seamless verification processes.
  • Provide technical guidance on verification methodologies and best practices.
  • Participate in cross-functional teams to support software development and regulatory compliance.
• Continuous Improvement:
  • Identify and implement improvements to verification processes and documentation practices.
  • Stay updated with industry trends, emerging technologies, and regulatory changes.
  • Contribute to the development of best practices and standard operating procedures.
• Reporting and Communication:
  • Prepare and present verification reports, including test results, defect status, and compliance metrics to senior management and stakeholders.
  • Communicate effectively with team members to ensure clear understanding of verification requirements and outcomes.
  • Participate in project meetings, providing updates on verification progress and issues.