Senior Software QA Engineer (Consultant)
About The Position
Element Science, Inc. is seeking an experienced Senior Software Quality Assurance Engineer Consultant to support software verification and validation activities for its medical device technology. This hands-on consulting role works closely with Software Engineering, Systems Engineering, and Quality teams to develop and execute software test strategies, expand test automation, troubleshoot technical issues, and ensure software meets performance, safety, and regulatory requirements. The consultant will conduct functional, integration, and system-level testing; create and maintain automated tests; configure and troubleshoot test environments and hardware/software interfaces; support design controls and risk management; and prepare traceable test documentation and reports. The role contributes to verification milestones and the safety, reliability, and performance of life-saving medical technology.
Requirements
- 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.
- 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 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.
- Hands-on, detail-oriented approach, with the ability to work independently and collaborate across technical disciplines.
Nice To Haves
- Experience developing and executing software test protocols in medical device development.
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 coverage gaps, and document findings for software verification activities.
- Design, develop, and maintain automated test scripts for UI, API, and integration testing.
- Configure, maintain, and troubleshoot test environments, test rigs, and hardware/software interfaces.
- Investigate software defects, reproduce issues, collaborate with Software Engineering on troubleshooting, 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 for design reviews, engineering approvals, and regulatory documentation.
- Collaborate with cross-functional teams to resolve outstanding issues and support timely completion of verification milestones.
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What This Job Offers
Career Level
Senior
