Senior Software Quality Engineer - Medical Robotics

Skills Alliance; Austin (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

Skills Alliance seeks a Senior Software Quality Engineer for Surgical Robotics within the Monogram Technologies robotics team in Texas. You will review and support software quality across the development lifecycle, collaborating with R&D, QA, and Regulatory to ensure FDA/ISO/IEC compliance.

This role emphasizes audit readiness, traceability, risk management, and hands-on validation across embedded and cloud-based software, with opportunities during regulatory inspections.

Qualifications

• Bachelor's degree in Computer Science, Computer Engineering, or related field.
• 4+ years of software validation and quality experience in a regulated environment.
• Strong grasp of V&V principles, test coverage, and objective evidence.
• Experience with risk management (ISO 14971).
• Knowledge of FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.
• Experience working cross functionally with R&D, QA, and Regulatory.

Responsibilities

• Reviewing requirements, design, and deliverables for compliance with FDA, ISO, and IEC 62304
• Reviewing and approving requirement specs, test plans, validation protocols, and traceability matrices (RTM)
• Ensuring traceability between requirements, risk controls, and verification evidence
• Supporting risk assessments and verifying risk control measures
• Taking part in design reviews, code reviews, and quality reviews
• Supporting change management, including impact assessment
• Developing and running test plans, test cases, and validation protocols
• Running functional, integration, and system level testing for embedded and cloud based software
• Supporting audit readiness and regulatory inspections

Skills

FDA/quality

V&V principles

Cross-functional collaboration

Education

Bachelor's degree in Computer Science/Computer Engineering

Job description

Skills Alliance seeks a Senior Software Quality Engineer for Surgical Robotics within the Monogram Technologies robotics team in Texas. You will review and support software quality across the development lifecycle, collaborating with R&D, QA, and Regulatory to ensure FDA/ISO/IEC compliance.

This role emphasizes audit readiness, traceability, risk management, and hands-on validation across embedded and cloud-based software, with opportunities during regulatory inspections.