Senior Design Quality Engineer for FDA-Regulated AI Health

Bazeta; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Bayesian Health seeks a Senior Design Quality Engineer to own software design quality, risk management, and regulatory submissions for FDA-cleared AI clinical decision support. You will read code, analyze logs, and guide engineers through IEC 62304, ISO 14971, and 21 CFR 820; manage post-market surveillance and CAPAs; collaborate with cross-functional teams to keep the QMS current as we scale.

You will work under the Head of Quality and Regulatory to ensure complaint handling, change control,

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 under ISO 13485 and IEC 62304.
• Experience with complaint handling and adverse event reportability decisions under 21 CFR 803 and 21 CFR 820, including CAPA.

Responsibilities

• Own software design quality across the full lifecycle with risk analysis, verification, validation, and release readiness per IEC 62304 and ISO 14971.
• Assess regulatory impact of changes, maintain risk files, and support post-market performance monitoring.
• Lead complaint handling, MDR trend analysis, CAPAs, and QMS improvements with cross-functional teams.

Skills

Code reading

Logs analysis

Regulatory knowledge

Written communication

Education

BS in Computer Science / Systems Engineering / Biomedical Engineering

Tools

IEC 62304

ISO 14971

21 CFR 820

21 CFR 803

Job description

Bayesian Health seeks a Senior Design Quality Engineer to own software design quality, risk management, and regulatory submissions for FDA-cleared AI clinical decision support. You will read code, analyze logs, and guide engineers through IEC 62304, ISO 14971, and 21 CFR 820; manage post-market surveillance and CAPAs; collaborate with cross-functional teams to keep the QMS current as we scale.

You will work under the Head of Quality and Regulatory to ensure complaint handling, change control,