Sr Quality Software Engineer

Senior Software Validation & Quality Engineer – Ability to travel to Austin, TX

We’re looking for a Senior Software Validation & Quality Engineer to support software quality, validation, and regulatory compliance for medical technology products. This role is ideal for someone experienced in regulated software environments who can provide software quality oversight while remaining hands-on with validation, verification, and testing activities.

Location: Remote Local To Austin for some onsite presence when needed

What You’ll Be Doing

• Perform software quality reviews of requirements, designs, and deliverables for compliance with FDA, ISO, and IEC 62304 standards .
• Ensure adherence to quality system and design control requirements throughout the SDLC .
• Review and approve requirements, test plans, validation protocols, Requirements Traceability Matrices (RTM) , and validation reports.
• Ensure software requirements are clear, complete, testable, and properly documented.
• Maintain end-to-end traceability between requirements, risk controls, and verification evidence .
• Participate in risk assessments and verify implementation of appropriate risk controls.
• Participate in design reviews, code reviews, and software quality reviews .
• Support software change management, including impact assessments and documentation.
• Develop and execute V&V test plans, test cases, and validation protocols .
• Perform functional, integration, and system-level testing for embedded software and cloud-based systems .
• Support defect investigations, root-cause analysis, and closure.
• Prepare teams and documentation for FDA and ISO audits and regulatory inspections .

What We’re Looking For

• 4+ years of software validation and quality experience within a regulated environment; medical device experience preferred.
• Bachelor’s degree in Computer Science, Computer Engineering, or a related field preferred.
• Strong understanding of software Verification & Validation (V&V) principles, test coverage, and objective evidence.
• Hands-on experience with test plans, validation protocols, execution reports, and RTMs.
• Knowledge of FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11 .
• Familiarity with ISO 14971 risk management and risk assessments.
• Experience with software change management and impact assessments.
• Understanding of configuration management, version control, and release traceability.
• Experience participating in design, code, and quality reviews.
• Ability to partner effectively across R&D, Quality Assurance, and Regulatory teams.