Job Summary:
The Software Test Engineer will perform manual testing and analysis to identify software defects, verify software requirements, and prepare test documentation in accordance with Quality Management System (QMS) and regulatory requirements. The role involves drafting and executing test protocols, coordinating formal testing cycles, managing defect resolution, and preparing test metrics and reports. The candidate will also provide technical leadership and guidance to Software Test Engineers while ensuring compliance with applicable medical device and industry standards.
Key Responsibilities:
• Draft, review, and execute software test protocols.
• Plan and coordinate schedules for formal testing cycles across multiple projects.
• Perform manual testing to verify software requirements, identify defects, and validate application functionality.
• Submit defect reports through defect tracking applications and follow up on resolution.
• Prepare weekly testing metrics and present regular status reports.
• Participate in Defect Review Board meetings and collaborate with Software Quality Engineers to follow up on features and defects.
• Review and update digital records of tasks, bugs, and requests within project management and tracking systems.
• Provide leadership and technical guidance to Software Test Engineers.
• Ensure testing activities and documentation comply with QMS processes and applicable regulatory requirements.
• Collaborate with cross-functional engineering and quality teams to support verification and validation activities.
Required Qualifications:
• Bachelor's degree in Biomedical Engineering, Mechatronics, Computer Engineering, or a related field.
• 5+ years of software testing experience, preferably within the medical device industry or another regulated environment.
• Hands-on experience performing manual testing across multiple projects.
• Proficiency in Verification and Validation (V&V), Design Controls, Software Development Life Cycle (SDLC) testing, and hardware testing.
• Strong understanding of FDA regulations, ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle), and EU MDR requirements.
• Experience drafting formal software requirements and test documentation.
• Strong understanding of risk assessment and mitigation processes.
• Experience using test equipment such as oscilloscopes and multimeters.
• Familiarity with diagnostic tools, CAD software such as SolidWorks, and scripting tools or languages such as Python, LabVIEW, and MATLAB.
• Proficiency in written and spoken English.
• Ability to provide technical leadership and coordinate testing activities across multiple projects.
