Remote Senior Design Quality Engineer - Medical AI

Devconnectplatform; Northern (KY); Remote; USD 120,000 - 160,000; Full time

Job summary

Bayesian Health hires a Senior Design Quality Engineer to ensure quality and regulatory compliance for FDA-cleared AI clinical software. You’ll own design controls, risk management, and post-market surveillance, coordinating with engineering and clinical teams.

You will read code, logs, and test evidence to drive quality improvements, support MDR/510(k) submissions, and maintain QMS procedures in a cloud/SaaS environment.

Qualifications

• Hands-on ownership of design controls and risk management in a regulated software environment.
• Experience with 21 CFR 820 and IEC 62304 in software medical devices.
• Ability to read code, logs, and test results to investigate software issues.

Responsibilities

• Own software design quality across the full lifecycle, including risk analysis and verification/validation.
• Assess regulatory impact of changes and manage change control through QMS.
• Support complaint handling, MDR/510(k) readiness, and post-market surveillance.
• Contribute to audits, supplier controls, and regulatory submissions.

Skills

Software quality

Design quality engineering

Regulatory work

Code/logs/test results analysis

Education

B.S. in Computer Science or related field

Tools

Jira-based defect tracking

eQMS platforms

Job description

Bayesian Health hires a Senior Design Quality Engineer to ensure quality and regulatory compliance for FDA-cleared AI clinical software. You’ll own design controls, risk management, and post-market surveillance, coordinating with engineering and clinical teams.

You will read code, logs, and test evidence to drive quality improvements, support MDR/510(k) submissions, and maintain QMS procedures in a cloud/SaaS environment.