Senior Design Quality Engineer — Remote Medical AI Platform

Bayesian Health; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

401(k)

Mental health support

Paid time off

Job summary

Bayesian Health is seeking a Senior Design Quality Engineer to ensure FDA-cleared, AI-driven clinical software meets design controls throughout development and post-market activities.

You will collaborate with engineering, data science, clinical, and implementation teams to embed quality into releases and maintain regulatory readiness under 21 CFR 820 and ISO 13485. You’ll own design quality, change control, complaint handling, and QMS maintenance in a fast-growing healthcare environment.

Qualifications

• BS in Computer Science, Systems Engineering, Biomedical Engineering or related field, or equivalent practical experience.
• 5+ years in software quality, design quality engineering, or regulatory work for software medical devices.
• Experience with ISO 13485, IEC 62304, and risk management per ISO 14971.
• Experience with 21 CFR 803/820, QSR/QMSR and post-market activities.
• Ability to read code, logs, and automated test results to investigate issues.

Responsibilities

• Embed quality into the full software lifecycle with engineering and data science teams.
• Own Change Control, risk management, and regulatory impact assessments.
• Lead complaint handling, MDR/510(k) considerations, and CAPA processes.
• Maintain and improve the QMS, document control, and supplier controls.
• Support FDA inspections, audits, and regulatory submissions.

Skills

Software quality

Design quality

Regulatory knowledge

QMS documentation

Code & log reading

Cloud-based SaaS

FDA cybersecurity

Regulatory communication

Education

BS in CS/EE/BME

Tools

eQMS

Jira

Job description

Bayesian Health is seeking a Senior Design Quality Engineer to ensure FDA-cleared, AI-driven clinical software meets design controls throughout development and post-market activities.

You will collaborate with engineering, data science, clinical, and implementation teams to embed quality into releases and maintain regulatory readiness under 21 CFR 820 and ISO 13485. You’ll own design quality, change control, complaint handling, and QMS maintenance in a fast-growing healthcare environment.