Senior Design Quality Engineer

What you'll do

• Drive design controls, risk management, verification and validation, traceability, and release readiness across the software lifecycle.
• Handle complaint triage and investigations, reportability assessments, post-market trends, nonconformances, and CAPAs.
• Maintain the QMS and regulatory records; support submissions, FDA interactions, audits, and algorithm change control.

What they ask for

• 5+ years in software quality, design quality engineering, or regulatory work for software medical devices under ISO 13485 and IEC 62304, including ownership of design controls and ISO 14971 risk management files.
• Experience with complaint handling, adverse event reportability decisions under 21 CFR 803 and 21 CFR 820 (QSR or QMSR), complaint investigation, trending, and CAPA.
• Track record writing and maintaining QMS procedures, document control, and change management in a regulated software environment; ability to investigate software issues using code, logs, and automated test results.
• Working knowledge of FDA premarket cybersecurity expectations under Section 524B; current, unrestricted authorization to work in the United States.

Nice to have

• Experience with AI/ML-enabled medical devices, algorithm change control, Predetermined Change Control Plans, model performance monitoring, and FDA AI/ML guidance.
• Experience preparing 510(k)s or Q-Submissions and corresponding with FDA reviewers.

Pay

$142,768 - $161,901 USD base salary

Tools

IEC 62304, ISO 14971, 21 CFR 820, 21 CFR 803, Section 524B, Epic, Oracle Health, SMART on FHIR

AI focus

Quality and regulatory work for an FDA-cleared AI clinical decision support platform, including algorithm change control and post-market performance monitoring.