Senior Design Quality Engineer
Bayesian Health, Inc. · Remote · Remote - US Only ·
COMPENSATION
€•• – ••k
Listed on the employer's job board (Ashby)
- Fully remote (US only)
- Senior level role
- FDA-cleared AI platform
- $142k - $161k salary
- No visa sponsorship
Join a mission-driven startup empowering clinicians with real-time data to improve patient outcomes. You will safeguard product quality for an AI-driven clinical platform integrated into Epic and Oracle Health workflows, managing the entire lifecycle from design controls to post-market surveillance.
What you'll do
- Partner with engineering on requirements, risk analysis, and validation per IEC 62304 and ISO 14971
- Maintain design history files and risk management records for regulatory defensibility
- Assess software and model changes for regulatory impact and drive change control processes
- Handle complaint intake, investigation, and MDR reportability assessments under 21 CFR 803
- Lead nonconformance reports and CAPAs when trends emerge in field data
- Maintain quality procedures, document control, and training records as the company scales
- Contribute to 510(k) submissions and respond to FDA questions during inspections
- Monitor emerging FDA guidance on AI/ML devices and cybersecurity requirements
What you'll need
- BS in Computer Science, Systems Engineering, Biomedical Engineering, or equivalent experience
- 5+ years in software quality or regulatory work for medical devices under ISO 13485
- Hands-on ownership of design controls and ISO 14971 risk management files
- Experience with complaint handling and adverse event reportability under 21 CFR 803
- Ability to read code, logs, and automated test results to investigate software issues
- Working knowledge of FDA premarket cybersecurity expectations and SBOM management
- Excellent written communication skills for audit-ready records and cross-functional clarity
- Current unrestricted authorization to work in the United States
Nice to have
- Experience with AI/ML-enabled medical devices and algorithm change control
- Direct experience preparing 510(k)s or Q-Submissions and corresponding with FDA
- Familiarity with EHR-integrated software like Epic, Oracle Health, or SMART on FHIR
- Experience supporting FDA inspections or ISO 13485 certification audits
- Experience with eQMS platforms, Jira-based defect tracking, and system validation
- ASQ CQE/CSQE, RAC, or equivalent quality or regulatory certification
Stack
- Epic
- Oracle Health
- Jira
- eQMS platforms
How you'll work
- Fully remote within the United States
- Synchronous hours: 11am-5pm ET (8am-2pm PT)
- Full-time employment with benefits
- No visa sponsorship available
What you get
- Medical, dental, and vision coverage with HSA option
- Company-paid life, short-term, and long-term disability insurance
- 401(k) retirement plan with investment choices
- Free mental health support via Spring Health
- Generous PTO, paid sick time, and holidays
- Equity participation in the company
- Annual fully paid company retreat
- Choice of Mac hardware and home office stipend