Senior Design Quality Engineer (Remote)

bayesianhealth; United States; Remote; USD 143,000 - 162,000; Full time

Benefits offered by this job

Remote-friendly culture

Equity

Job summary

Bayesian Health seeks a Senior Design Quality Engineer to shape the software quality program across design, post-market, and regulatory areas. You will collaborate with engineering, data science, clinical, and implementation teams to ensure robust QMS and compliant AI-driven clinical decision support.

You will own design controls, oversee change management, and drive regulatory submissions in a fast-growing, remote-first environment.

Qualifications

• 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.
• Proven record writing and maintaining QMS procedures, document control, and change management in a regulated software environment.
• Ability to read code, logs, and automated test results to investigate issues independently.
• Knowledge of FDA premarket cybersecurity expectations (Section 524B).
• Excellent written communication; ability to explain regulatory concepts to diverse audiences.
• Current, unrestricted authorization to work in the United States.

Responsibilities

• Design Quality: manage full lifecycle with IEC 62304, ISO 14971, 21 CFR 820 controls; maintain design history and risk files.
• Change Control: assess changes for regulatory impact and drive through QMS; support post-market monitoring.
• Complaint & Post-Market: handle intake, triage, investigation, MDR assessments, CAPAs when patterns arise.
• QMS Maintenance: update procedures, document control, training records; support audits and supplier controls.
• Regulatory Submissions: contribute to 510(k)s, Q-Submissions, and change control plans.
• Regulatory Intelligence: monitor FDA AI/ML guidance and translate requirements to procedures.
• Cross-Functional: embed quality into product/engineering teams; communicate metrics clearly.

Skills

Regulatory software quality

Regulatory complaint handling

QMS procedures & document control

Code/logs/test evidence reading

FDA cybersecurity knowledge

Excellent written communication

Drive & process-fixer mindset

US work authorization

Education

BS in CS, Systems Eng, Biomed Eng or related field

Tools

eQMS platforms

Jira defect tracking

Epic/Oracle Health familiarity

Job description

Bayesian Health seeks a Senior Design Quality Engineer to shape the software quality program across design, post-market, and regulatory areas. You will collaborate with engineering, data science, clinical, and implementation teams to ensure robust QMS and compliant AI-driven clinical decision support.

You will own design controls, oversee change management, and drive regulatory submissions in a fast-growing, remote-first environment.