Note: The job is a remote job and is open to candidates in USA. Element Science, Inc. is seeking a Senior Software QA Engineer Consultant to support software verification and validation for its medical device technology. The role develops and executes software testing strategies, expands test automation, troubleshoots issues, and supports design controls and regulatory compliance.
Responsibilities
- Develop, review, and execute software test protocols and test cases aligned with product requirements and design specifications
- Perform functional, integration, and system-level testing to verify software performance, reliability, and compliance
- Analyze test results, identify gaps in coverage, and document findings to support software verification activities
- Design, develop, and maintain automated test scripts for UI, API, and integration testing to improve efficiency and repeatability
- Configure, maintain, and troubleshoot test environments, test rigs, and hardware/software interfaces
- Investigate software defects, reproduce issues, and collaborate with Software Engineering to troubleshoot problems and verify corrective actions
- Develop and maintain software verification plans, requirements traceability matrices, and other design control documentation
- Support software risk management activities, including hazard analysis, FMEA, and risk traceability
- Ensure testing activities and documentation align with applicable medical device quality and regulatory requirements
- Prepare formal test reports summarizing execution results, requirements coverage, defects, and outstanding risks
- Maintain accurate, traceable test records to support design reviews, engineering approvals, and regulatory documentation
- Collaborate with cross-functional teams to resolve outstanding issues and support timely completion of verification milestones
Skills
- Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline, or equivalent relevant experience
- Demonstrated experience in software quality assurance, verification and validation, and test automation
- Experience developing and executing software test protocols in a regulated product development environment, preferably medical devices
- Proficiency in automated testing frameworks, scripting, and software debugging techniques
- Experience testing software integrated with hardware, embedded systems, or complex electromechanical devices
- Working knowledge of medical device design controls, software requirements traceability, and risk management
- Familiarity with applicable medical device software standards, including IEC 62304, ISO 14971, and FDA design control requirements
- Experience documenting software defects, collaborating with development teams, and verifying software fixes
- Strong analytical, troubleshooting, documentation, and communication skills
- A hands-on, detail-oriented approach with the ability to work independently and collaborate effectively across technical disciplines
- We are not able to sponsor individuals for employment visas for this job
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