Senior Design Quality Engineer

The role

You will safeguard product quality for an FDA-cleared, AI-driven clinical platform. This includes managing design controls, complaint investigations, and the quality management system.

What you will do

• Partner with engineering and data science through the full software lifecycle
• Keep the design history file and risk management file current
• Assess software and model changes for regulatory impact
• Support complaint intake, triage, investigation, and closure
• Prepare MDR reportability assessments
• Lead nonconformance reports and CAPAs
• Maintain and update quality procedures, document control, and training records
• Support internal audits and manage supplier controls
• Contribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans
• Monitor FDA guidance on AI/ML-enabled devices and cybersecurity

Required qualifications

• BS in Computer Science, Systems Engineering, Biomedical Engineering, or a related technical 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
• Hands-on ownership of design controls and ISO 14971 risk management files
• Experience with complaint handling and adverse event reportability decisions under 21 CFR 803 and 21 CFR 820
• Experience with complaint investigation, trending, and CAPA
• Track record of writing, maintaining, and improving QMS procedures, document control, and change management
• Ability to read code, logs, and automated test results
• Working knowledge of FDA premarket cybersecurity expectations under Section 524B
• Excellent written communication
• Current, unrestricted authorization to work in the United States

Nice to have

• Experience with AI/ML-enabled medical devices
• Direct experience preparing 510(k)s or Q-Submissions
• Familiarity with EHR-integrated software such as Epic or Oracle Health, SMART on FHIR, or CDS Hooks
• Experience supporting a lead or primary contact in FDA inspections, ISO 13485 certification audits, or customer audits
• Experience with eQMS platforms, Jira-based defect tracking, and computerized system validation
• An ASQ CQE/CSQE, RAC, or equivalent quality or regulatory certification

Benefits

• Medical, Dental & Vision coverage through Anthem Blue Cross Blue Shield, Guardian/VSP
• Access to One Medical
• Life insurance, short-term disability, and long-term disability
• 401(k) retirement plan
• Free mental health support through Spring Health
• Pet care benefits
• Generous PTO, paid sick time, paid holidays, and company-wide self-care days
• Equity
• Fully paid annual company retreat
• Choice of Mac hardware
• One-time home office stipend
• Ongoing reimbursement for internet and phone costs

Before you apply

• Bayesian Health does not provide visa sponsorship for this position

About the company

Bayesian Health is a startup on a mission to make healthcare proactive by empowering clinicians with real-time data. They build AI-driven clinical decision support software that integrates into Epic and Oracle Health workflows.