Senior Design Quality Engineer

About the role

Bayesian Health is seeking a Senior Design Quality Engineer to safeguard product quality for an FDA-cleared, AI-driven clinical platform. This role involves managing design controls, complaint investigations, and the quality management system while ensuring regulatory compliance as the company scales. You will work cross-functionally with engineering, data science, and clinical teams to integrate quality processes into the software development lifecycle.

Responsibilities

• Partner with engineering and data science through the full software lifecycle including requirements, risk analysis, and validation.
• Maintain the design history file and risk management file in accordance with IEC 62304 and ISO 14971.
• Assess software and model changes for regulatory impact and drive changes through the quality management system.
• Support complaint intake, investigation, and closure, including MDR reportability assessments.
• Maintain and update quality procedures, document control, and training records.
• Contribute to regulatory submissions such as 510(k)s and Q-Submissions and support FDA inspections.
• Monitor FDA guidance on AI/ML-enabled devices and translate requirements into product procedures.

Required skills

• Software quality engineering
• Design controls
• ISO 14971
• IEC 62304
• 21 CFR 803
• 21 CFR 820
• Risk management
• QMS maintenance
• Regulatory compliance
• Cybersecurity

Nice to have

• AI/ML-enabled medical devices
• 510(k) submissions
• EHR-integrated software
• SMART on FHIR
• CDS Hooks
• eQMS platforms
• Jira

Qualifications

• BS in Computer Science, Systems Engineering, Biomedical Engineering, or a related technical field
• Equivalent practical experience

Certifications

• ASQ CQE
• ASQ CSQE
• RAC

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short-term disability
• Long-term disability
• 401(k)
• Mental health support
• Paid time off
• Home office stipend

About the Company

Bayesian Health is a mission-driven startup focused on improving patient outcomes by empowering clinicians with real-time data insights. The company is backed by top-tier investors and has been recognized by Forbes, the World Economic Forum, and Time for its AI-driven clinical decision support software.