Senior Design Quality Engineer — FDA-Regulated AI

Jobicy; Northern (KY); On-site; USD 143,000 - 162,000; Full time

Job summary

Bayesian Health, a fast-growing startup, is seeking a Senior Design Quality Engineer to ensure design controls, regulatory compliance, and post-market surveillance for an FDA-cleared AI clinical decision support platform.

You will own software design quality, evaluate changes for regulatory impact, manage complaint handling, MDR assessments, and maintain the quality management system as the team scales, working with engineering, data science, clinical and implementation teams.

Qualifications

• Must understand design controls and regulatory obligations for medical device software.
• Experience implementing traceability from requirements to release evidence.
• Familiarity with post-market surveillance and CAPA processes.

Responsibilities

• Engineer quality into software as it’s built and through release readiness.
• Handle post-market activities including complaint handling and MDR assessments.
• Maintain the quality management system and regulatory records as the company scales.

Skills

Traceability

Regulatory compliance

Software design quality

FDA/IEC 62304

Job description

Bayesian Health, a fast-growing startup, is seeking a Senior Design Quality Engineer to ensure design controls, regulatory compliance, and post-market surveillance for an FDA-cleared AI clinical decision support platform.

You will own software design quality, evaluate changes for regulatory impact, manage complaint handling, MDR assessments, and maintain the quality management system as the team scales, working with engineering, data science, clinical and implementation teams.