Software Quality Engineer

Software Quality Engineer

Our client is seeking a Software Quality Engineer to partner closely with the software engineering team across the product platform, with an immediate focus on R&D software development. This role provides hands-on quality engineering support for software used in medical devices and Software as a Medical Device (SaMD), ensuring software development activities are executed with appropriate rigor, traceability, and objective evidence.

The ideal candidate will work directly with engineering teams on software requirements reviews, architecture and interface reviews, code review processes, defect triage, verification and validation, change control, and Design History File (DHF) deliverables. This role requires balancing product development speed with disciplined design controls and quality decision-making.

The candidate should have experience with FDA regulations and guidance related to device software functions, including software validation, cybersecurity expectations, and quality management system (QMS) requirements. Success in this role requires strong cross-functional collaboration with Software Engineering, Systems, Hardware, Clinical, Quality/Regulatory, Manufacturing, and Service teams to support safe, reliable, and effective products.

Key Responsibilities

Software Lifecycle & Design Controls

• Provide quality engineering support throughout the software development lifecycle for medical device software and SaMD, from user needs and design inputs through release and post-market changes.
• Ensure software lifecycle activities and records comply with the company QMS and applicable FDA regulations and guidance related to software validation, cybersecurity, and design controls.
• Own software design control activities for Gen 4 development and Gen 3 sustaining efforts, including requirements, review records, traceability, verification, validation, and release documentation.
• Partner with Software Engineering, Systems Engineering, and Regulatory teams to establish practical design control deliverables, review processes, approval workflows, and DHF expectations.
• Drive traceability from user needs and design inputs through software requirements, risk controls, verification, validation, and release documentation.
• Support software-related change control activities, release readiness decisions, and sustaining updates.

Requirements, Reviews & Risk Management

• Review software requirements for clarity, completeness, consistency, traceability, and testability while ensuring alignment with intended use, system needs, and risk controls.
• Participate in software architecture reviews, interface reviews, software risk reviews, change impact assessments, and design reviews.
• Ensure code review processes are defined, followed, and properly documented, with findings and action items tracked to closure.
• Partner with project teams on software hazard analysis, anomaly assessments, unresolved defect disposition, and risk-control verification activities.
• Support complaint investigations, CAPA activities, audit readiness, inspection readiness, and cross-functional issue resolution under the company QMS.

Verification & Validation

• Review and approve software V&V strategies, protocols, scripts, traceability matrices, summary reports, and supporting objective evidence required for release and regulatory submissions.
• Ensure software V&V activities adequately cover requirements, intended use, risk controls, cybersecurity features, interfaces, alarms, regression testing, and known edge cases.

Qualifications

Required

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related technical field.
• 5+ years of experience in software quality engineering, design assurance, software QA, or a related role within a regulated medical device environment.
• Experience supporting software development for medical device software and/or SaMD, including new product development and sustaining changes.
• Strong knowledge of FDA regulations and guidance applicable to device software functions, including design controls, software validation, cybersecurity expectations, complaint/CAPA processes, and submission-supporting software documentation.
• Experience reviewing software requirements, architecture/design documentation, code review records, traceability matrices, V&V protocols and reports, anomalies, and release documentation.
• Working knowledge of medical device risk management and usability standards, including IEC 62304, ISO 14971, IEC 62366, and ISO 13485-based quality systems.
• Strong analytical, documentation, and problem-solving skills with the ability to make risk-based recommendations and uphold quality expectations.

Preferred

• Experience supporting FDA submissions or major design changes involving device software functions, including preparation or review of submission-ready software documentation.
• Experience with embedded software, firmware, user-interface software, connected device features, or cybersecurity activities within medical devices.
• Familiarity with automated testing practices, static analysis, defect tracking systems, and modern software development workflows in regulated environments.