Senior Software Test Engineer

About the Company

The Senior Software Test Engineer leads software verification and validation activities for the next-generation Class III active medical device. This role owns test strategy and execution across the full system stack — embedded and mobile applications, and cloud platform/services. The individual ensures that all software components meet safety, performance, and regulatory requirements under IEC 62304 and 21 CFR Part 820, and directly supports PMA design control documentation and FDA submissions. This role requires deep technical expertise in verification within regulated environments, and the ability to drive quality outcomes in an Agile/SCRUM development team.

About the Role

Own and execute verification and validation strategies across all software components — embedded firmware, embedded application, mobile, and cloud infrastructure.

Responsibilities

• Develop and maintain test plans, protocols, scripts, and reports in compliance with IEC 62304 and 21 CFR Part 820 design control and quality system requirements.
• Design, implement, and maintain automated and manual test frameworks for .NET/C#, MAUI/Blazor-based components.
• Partner with the development team to review software requirements, architecture, interface definitions, and risk analyses, ensuring complete test coverage from the outset.
• Maintain end-to-end traceability between system requirements, hazard analysis outputs, test cases, and defect records.
• Lead integration, system, and regression testing across firmware-to-application and application-to-cloud interfaces including Bluetooth connectivity and cloud data flows.
• Integrate test automation into Azure DevOps CI/CD pipelines; contribute to and enforce test-related toolchain conventions including Git and pipeline configurations.
• Participate in Agile/SCRUM ceremonies as the verification representative, contributing to sprint planning, definition of done, and release readiness decisions.
• Lead root cause investigations, defect analysis, and CAPA activities related to software quality findings.
• Support design control deliverables including verification strategy documentation, test summary reports, and traceability matrices for PMA submissions; participate in internal and external audits, regulatory inspections, and CAPA activities.
• Mentor junior engineers in software verification practices, regulatory expectations, and toolchain usage; collaborate closely with Quality and Regulatory teams.
• Contribute to and help enforce test-related conventions within the team's toolchain: Azure DevOps, Git, and CI/CD pipeline configurations.

Qualifications

• Bachelor's degree in Software Engineering, Computer Science, or related discipline.
• 5 years of software test engineering experience with 2 years in regulated medical device environments; Class III implantable device experience strongly preferred.
• Demonstrated experience with IEC 62304 and 21 CFR Part 820, including support for FDA PMA or 510(k) submissions with complete test documentation and traceability artifacts.
• Hands-on proficiency with testing embedded and mobile applications including data integrity and edge case validation.
• Proficiency with Azure DevOps, pipeline integration, and defect tracking; experience developing and executing automated test frameworks integrated into CI/CD pipelines; familiarity with Azure cloud services including logging and monitoring.
• Experience testing Bluetooth/wireless connectivity and gRPC service interfaces in connected or implantable device systems; familiarity with cybersecurity testing practices per FDA guidance for connected medical devices.
• Solid understanding of software architecture, design patterns, and system decomposition sufficient to derive effective test strategies from design documentation; experience with Figma or equivalent for UI/UX acceptance validation.
• Strong written and verbal communication skills; able to articulate verification status, technical risks, and findings to cross-functional stakeholders including Quality, Regulatory, and Clinical teams.
• Comfortable with context switching and investigation of complex system issues.

Required Skills

Proficiency with Azure DevOps, pipeline integration, and defect tracking; experience developing and executing automated test frameworks integrated into CI/CD pipelines; familiarity with Azure cloud services including logging and monitoring.

Preferred Skills

Experience testing Bluetooth/wireless connectivity and gRPC service interfaces in connected or implantable device systems; familiarity with cybersecurity testing practices per FDA guidance for connected medical devices.

Pay range and compensation package

Not specified.

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices.