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