Senior Software QA Engineer (Consultant)
Element Science
Summary
We're seeking an experienced Senior Software Quality Assurance Engineer Consultant to support software verification and validation activities for our life-saving medical device technology.
Job description
About the Opportunity
We're seeking an experienced Senior Software Quality Assurance Engineer Consultant to support software verification and validation activities for our life-saving medical device technology.
In this hands-on consulting role, you'll work closely with Software Engineering, Systems Engineering, and Quality teams to develop and execute software test strategies, expand test automation, troubleshoot complex technical issues, and ensure our software meets rigorous performance, safety, and regulatory requirements.
What You'll Do
Software Testing & Verification
- 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.
Test Automation & Troubleshooting
- 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.
Design Controls & Risk Management
- 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.
Test Reporting & Documentation
- 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.
What You'll Bring
- 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.
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, 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 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 ability to work independently and collaborate across technical disciplines
Company overview
Element Science is a San Francisco-based medical device and digital health company founded in 2011 by Dr. Uday Kumar, a cardiac electrophysiologist and founder of iRhythm Technologies. The company specializes in developing innovative wearable solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies to address leading causes of death and hospitalization in patients with heart disease. Element Science's flagship product is the Jewel® Patch Wearable Cardioverter Defibrillator (Patch-WCD), an unobtrusive, low-profile personal defibrillator designed to detect and treat life-threatening arrhythmias in patients at temporary risk of Sudden Cardiac Death. The company's next-generation digital wearable platform combines human-centric engineering, sophisticated machine learning, and rigorous medical device standards to reduce death and hospitalization from cardiovascular conditions. Backed by prominent investors including Third Rock Ventures, Google Ventures, Deerfield Healthcare, and Qiming Venture Partners, Element Science has raised significant funding, including a $145.6 million Series C round in 2020. The company received FDA approval for its revolutionary Jewel Patch-WCD in 2025, marking a significant milestone in cardiac care innovation.