Senior Design Quality Engineer

About the role

The Senior Design Quality Engineer will safeguard product quality for an FDA-cleared, AI-driven clinical platform throughout the software lifecycle. This role involves managing design controls, complaint investigations, and regulatory compliance while collaborating with engineering, data science, and clinical teams. You will ensure the quality management system remains robust and defensible as the company scales.

Responsibilities

• Partner with engineering and data science on requirements, architecture review, software risk analysis, and verification and validation.
• Maintain the design history file and risk management file in accordance with IEC 62304, ISO 14971, and 21 CFR 820.
• Assess software and model changes for regulatory impact and drive changes through the quality management system.
• Support complaint intake, triage, 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.

Required skills

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

Nice to have

• AI/ML medical devices
• 510(k) submissions
• EHR integration
• SMART on FHIR
• CDS Hooks
• Jira
• Computerized system validation

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 for its AI-driven clinical decision support software.