Senior Software QA Engineer (Consultant)

Regulatory Toolkit; San Francisco (CA); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Element Science, Inc. seeks a Senior Software Quality Assurance Engineer Consultant to support software verification and validation for life-saving medical device technology.

You will collaborate with Software, Systems, and Quality teams to develop test strategies, expand automation, and ensure compliance with design controls and regulatory requirements. The role emphasizes hands-on testing, debugging, and risk management for embedded software in a regulated environment, with opportunities to

Qualifications

• Bachelor's degree in a technical discipline or equivalent experience.
• Experience in software quality assurance, verification and validation, and test automation.
• Experience documenting software defects and working in regulated medical device environments.

Responsibilities

• Develop, review, and execute software test protocols aligned with product requirements and design specs.
• Design, implement, and maintain automated tests for UI, API, and integration testing; troubleshoot environments and interfaces.
• Prepare formal test reports and ensure traceability with design controls and risk management.

Skills

Software testing

Test automation

Embedded software

Regulated environment

Documentation

Education

Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related field

Tools

Test automation frameworks

Scripting languages

Hardware interfacing

Job description

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery.

We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Cormorant Asset Management, and Invus Opportunities.

Senior Software Quality Assurance Engineer Consultant

Consulting Opportunity | Medical Device Software | R&D

About the Opportunity

We're seeking an experiencedSenior 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.

The ideal consultant brings a strong foundation in software testing and automation, experience working with embedded or hardware-integrated software, and a practical understanding of design controls in regulated medical device development.

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.

Why Partner With Element Science?

At Element Science, quality and innovation go hand in hand. The software we develop plays a critical role in the performance and reliability of technology designed to protect patients when they need it most.

As a consultant, you'll have the opportunity to tackle meaningful engineering challenges, collaborate with talented technical teams, and directly contribute to the safety, reliability, and performance of life-saving medical technology.

Ready to put your software testing expertise to work on technology that matters? We'd love to connect.

Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.We are not able to sponsor individuals for employment visas for this job.

At this time, we are unable to offer relocation assistance at Element Science.