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Salary: USD 142,768 - 161,901 / annual
Bayesian Health is a venture-backed healthtech startup building FDA-cleared, AI-driven clinical decision support software that integrates directly into Epic and Oracle Health workflows at health systems nationwide. The company is on a mission to empower clinicians with real-time data to improve patient outcomes and has received recognition from Forbes AI Top 50, World Economic Forum Tech Pioneer, and Time Best Inventions.
As Senior Design Quality Engineer, you will safeguard product quality across the entire lifecycle of an FDA-regulated medical device platform. This role intentionally spans multiple domains: pre-market design controls and verification/validation, post-market complaint handling and adverse event reporting, and ongoing quality management system maintenance and improvement.
Key responsibilities include:
**Software Design Quality**: Partner with engineering and data science teams through the full software lifecycle—requirements, architecture review, software risk analysis, verification and validation, traceability, and release readiness. Maintain design history files and risk management files in accordance with IEC 62304, ISO 14971, and 21 CFR 820 (QMSR).
**Change Control & Algorithm Lifecycle**: Assess software and model changes for regulatory impact, determine whether a letter-to-file or new FDA submission applies, and drive changes through the quality management system. Maintain risk files and support post-market performance monitoring of deployed algorithms.
**Complaint Handling & Post-Market Surveillance**: Support complaint intake, triage, investigation, and closure. Prepare MDR reportability assessments under 21 CFR 803, trend complaints and field data, and lead nonconformance reports and CAPAs when patterns emerge.
**QMS Improvement & Maintenance**: Maintain and update quality procedures, document control, training records, and compliance evidence as the company scales. Support internal audits, prepare management review inputs, and manage supplier controls for EHR, cloud, and subcontractor relationships.
**Regulatory Interactions & Submissions**: Contribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans. Respond to FDA questions and support the team during FDA inspections.
**Regulatory Intelligence**: Monitor FDA guidance on AI/ML-enabled devices, cybersecurity under Section 524B, and quality system expectations. Translate emerging requirements into concrete changes to procedures and product requirements.
**Cross-Functional Collaboration**: Embed compliance into product, engineering, and commercial workflows so quality accelerates delivery. Communicate quality metrics and risk clearly to technical and non-technical audiences, including executives.
You will report to the Head of Quality and Regulatory and work directly with engineering, data science, clinical, and implementation teams. This is a small-company role that requires versatility, ownership, and the ability to investigate software issues independently by reading code, logs, and test results.
**Requirements:**
- BS in Computer Science, Systems Engineering, Biomedical Engineering, or 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, including 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 (QSR or QMSR), including complaint investigation, trending, and CAPA
- Track record of writing, maintaining, and improving QMS procedures, document control, and change management in a regulated software environment
- Ability to read code, logs, and automated test results well enough to investigate software issues independently; comfort working with engineers in cloud-based SaaS environments
- Working knowledge of FDA premarket cybersecurity expectations under Section 524B, including threat modeling, SBOM management, and vulnerability handling
- Excellent written communication; ability to produce audit-ready records and explain regulatory concepts to engineers, clinicians, and executives without losing precision
- High drive, process-fixer mindset, ability to learn fast and communicate clearly
- Current, unrestricted authorization to work in the United States (no visa sponsorship available)
**Nice to Haves:**
- Experience with AI/ML-enabled medical devices, including algorithm change control, Predetermined Change Control Plans, model performance monitoring, and FDA AI/ML guidance
- Direct experience preparing 510(k)s or Q-Submissions and corresponding with FDA reviewers
- Familiarity with EHR-integrated software (Epic, Oracle Health, SMART on FHIR, CDS Hooks) and enterprise health system security/quality due diligence
- Experience supporting FDA inspections, ISO 13485 certification audits, or customer audits
- Experience with eQMS platforms, Jira-based defect tracking, and computerized system validation
- ASQ CQE/CSQE, RAC, or equivalent quality/regulatory certification
