Senior Test Lead

Job Summary

Position Summary

Abiomed is seeking a Senior or Principal Software Test Engineer to support software verification and test simulator development for next-generation Class III medical device software. The role spans embedded systems, user interfaces, cloud-connected applications, and integrated device platforms. The engineer will partner across Software, Systems, Product Security, and Quality Engineering to deliver risk-based verification, expand automation, and maintain compliant design-control evidence.

The successful candidate combines strong technical judgment, disciplined quality engineering, and the ability to influence cross-functional teams in a fast-paced, regulated environment.

Key Responsibilities

• Develop and execute risk-based verification strategies for complex medical device software, including unit, integration, system, regression, performance, and simulator-based testing.
• Analyze software and system requirements; establish testable acceptance criteria and maintain end-to-end traceability among requirements, test cases, risk controls, defects, and results.
• Design, automate, and maintain test cases, frameworks, tools, environments, and infrastructure for embedded platforms, communication interfaces, cloud-connected services, and user-facing applications.
• Integrate automated testing into CI/CD pipelines to improve verification efficiency, repeatability, and coverage.
• Create and maintain test plans, protocols, procedures, traceability matrices, reports, and other quality records required for product development and regulatory compliance.
• Investigate defects, support root cause analysis, and verify corrective actions in collaboration with software and systems teams.
• Verify software risk controls and contribute to hazard analyses, FMEA reviews, design reviews, release-readiness assessments, and product quality decisions.
• Support audits, inspections, regulatory submissions, and Design History File deliverables.
• Drive continuous improvement in software quality processes, test methodologies, and automation capabilities; at the Principal level, lead cross-team verification efforts and mentor engineers.

Key Responsibilities

Position Summary

Abiomed is seeking a Senior or Principal Software Test Engineer to support software verification and test simulator development for next-generation Class III medical device software. The role spans embedded systems, user interfaces, cloud-connected applications, and integrated device platforms. The engineer will partner across Software, Systems, Product Security, and Quality Engineering to deliver risk-based verification, expand automation, and maintain compliant design-control evidence.

The successful candidate combines strong technical judgment, disciplined quality engineering, and the ability to influence cross-functional teams in a fast-paced, regulated environment.

Key Responsibilities

• Develop and execute risk-based verification strategies for complex medical device software, including unit, integration, system, regression, performance, and simulator-based testing.
• Analyze software and system requirements; establish testable acceptance criteria and maintain end-to-end traceability among requirements, test cases, risk controls, defects, and results.
• Design, automate, and maintain test cases, frameworks, tools, environments, and infrastructure for embedded platforms, communication interfaces, cloud-connected services, and user-facing applications.
• Integrate automated testing into CI/CD pipelines to improve verification efficiency, repeatability, and coverage.
• Create and maintain test plans, protocols, procedures, traceability matrices, reports, and other quality records required for product development and regulatory compliance.
• Investigate defects, support root cause analysis, and verify corrective actions in collaboration with software and systems teams.
• Verify software risk controls and contribute to hazard analyses, FMEA reviews, design reviews, release-readiness assessments, and product quality decisions.
• Support audits, inspections, regulatory submissions, and Design History File deliverables.
• Drive continuous improvement in software quality processes, test methodologies, and automation capabilities; at the Principal level, lead cross-team verification efforts and mentor engineers.

Skill Requirements

Required Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, Computer Engineering, or a related technical discipline.
• Senior level: 5+ years of experience in software test engineering, quality engineering, or software verification and validation.
• Principal level: 10+ years of relevant experience, including demonstrated technical leadership.

Required Technical Experience

• Testing embedded software, connected systems, or other complex software-based products across requirements-based, integration, system, and regression test levels.
• Developing automated test frameworks and solutions using Python, C/C++, Bash, or comparable programming and scripting languages.
• Troubleshooting software and system-level issues and collaborating with development teams through defect resolution.
• Applying software development and test lifecycles, source control, CI/CD pipelines, and automated test environments.
• Producing verification documentation, including test plans, protocols, traceability matrices, and reports.
• Using application lifecycle management and issue-tracking tools such as Jama and Jira.
• Communicating clearly, solving complex problems, and collaborating effectively across technical and quality functions.

Preferred Qualifications

• Experience developing or testing Class II or Class III medical devices and supporting regulatory submissions, audits, inspections, or Design History File development.
• Working knowledge of IEC 62304, ISO 14971, FDA Design Controls, and software validation principles.
• Experience with Embedded Linux, distributed systems, cloud-connected applications, or networked medical devices.
• Experience with software-in-the-loop, hardware-in-the-loop, simulation-based testing, or test environment development.
• Experience testing CAN, CAN-FD, CANopen, Ethernet, UART, SPI, I2C, or similar communication protocols.
• Familiarity with cybersecurity verification, vulnerability assessment, and secure software development practices.
• Experience leading verification across multiple teams and mentoring engineers in quality engineering practices.
• ISTQB, CSQE, or an equivalent quality-related certification.

Other Requirements

Level Expectations

Senior Software Test Engineer

Principal Software Test Engineer

Independently owns complex verification work, develops automation, resolves technical issues, and collaborates across functions.

Provides technical leadership across teams, helps define verification direction, influences quality strategy, and mentors engineers.