What else we look for (Preferred):
• Experience with IEC 62304 Medical Device Software
• Experience with hardware-software integration.
• Experience in software and hardware system testing, test design, data acquisition and analysis.
• Strong technical writing skills.
• Experience in Medical Device regulations standards and SW design, life cycle and V&V
• Knowledge of HW/SW protocols
• UI Experience
• Proficiency with Azure DevOps (ADO) for test management, traceability, and Agile execution.
• Strong technical writing skills and the ability to collaborate effectively across engineering, quality, and regulatory teams.
• Familiarity with design control processes for medical devices or Software as a Medical Device (SaMD).
• Deep understanding of SDLC documentation, including requirements, design controls, V&V evidence, and traceability.
• Experience developing compliant documentation aligned to FDA 21 CFR Part 820, IEC 62304, ISO 13485, and ISO 14971.
• Strong familiarity with global regulatory frameworks for medical devices and SaMD (FDA, IMDRF).
• Experience with cybersecurity, interoperability, or wireless (e.g., BLE) testing for connected devices.
• Exposure to modern ALM and traceability tools (Jira, Jama, Codebeamer, Helix ALM, TestRail).
• Background in cardiac, hemodynamic, or implantable medical technologies.
• Relevant certifications such as ISTQB Advanced, CSTE, or ASQ.
• Troubleshooting mindset, able to systematically and effectively break down a system or process into subparts to identify failure mechanisms.
• Proactive attitude, excellent teamwork and interpersonal skills including negotiating and relationship management.
• Solid problem-solving, organizational, analytical, and critical thinking skills.
• Must work well both independently and as a member of a cross-functional team in a dynamic environment.
• Capable to quickly learn and interpret complex test systems.
• Must be a highly motivated self-starter who is driven to achieve quality and value-add results. Candidate must seek direction when appropriate.