Senior Design Quality Engineer

About the Role

Bayesian Health is a rapidly growing startup on a mission to make healthcare proactive by empowering physicians, nurses, and care team members with real-time data to save lives. The company’s FDA-cleared, AI-driven clinical decision support software integrates directly into Epic and Oracle Health workflows at health systems across the country. Bayesian’s diverse team includes clinicians, engineers, AI experts, product designers, and performance improvement leaders, backed by investors such as Obvious Ventures, Andreessen Horowitz, the American Medical Association’s venture arm, Catalio Partners, and LifeForce Capital. Recent recognitions include Forbes AI Top 50, World Economic Forum Tech Pioneer, Time Best Inventions, and BioTech AI Company of the Year, with peer-reviewed research published in Nature Medicine associating products with improved patient outcomes.

This senior individual contributor role sits within the Quality & Regulatory team, reporting to the Head of Quality & Regulatory. You will safeguard product quality across the full lifecycle — from design controls during development, to complaint investigation and post-market surveillance once the platform is live in hospitals, to maintaining the quality management system and regulatory record that hold it all together. You will partner with engineering, data science, clinical, and implementation teams, serving as the engineer in the room on quality questions: when a hospital reports an alert didn’t behave as expected, you decide whether it’s a complaint, whether it’s reportable, and what changed in the software or data, reading code, logs, and test evidence to find out.

Responsibilities

• Software Design Quality: Partner with engineering and data science through the full software lifecycle — requirements, architecture review, software risk analysis, verification and validation, traceability, and release readiness — in accordance with IEC 62304, ISO 14971, and 21 CFR 820 (QMSR) design controls. Keep the design history file and risk management file current, right-sized, and defensible.
• Change Control & Algorithm Lifecycle: Assess software and model changes for regulatory impact, determining whether a letter-to-file or a new submission applies, and drive the change through the quality management system. Maintain the risk file and support post-market performance monitoring of the deployed algorithm.
• Complaint Handling & Post-Market Surveillance: Support complaint intake, triage, investigation, and closure. Prepare MDR reportability assessments under 21 CFR 803 for review and approval, trend complaints and field data, and lead nonconformance reports and CAPAs when patterns emerge. Work closely with implementation and clinical teams to ensure client feedback reaches the quality system.
• QMS Improvement & Maintenance: Maintain and update quality procedures, document control, training records, and compliance evidence as the company grows. 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 how product, engineering, and commercial teams already work so that quality speeds delivery rather than slowing it down. Communicate quality metrics and risk clearly to technical and non-technical audiences, including executives.

Requirements

• 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, 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 a software issue independently, and comfort working with engineers in a cloud-based SaaS environment
• Working knowledge of FDA premarket cybersecurity expectations under Section 524B, including threat modeling, SBOM management, and vulnerability handling
• Excellent written communication: produce audit-ready records and explain regulatory concepts to engineers, clinicians, and executives without losing precision
• High level of drive, a process-fixer mindset rather than a process-follower one, and the ability to learn fast and communicate clearly
• Current, unrestricted authorization to work in the United States

Preferred Qualifications

• 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 such as Epic or Oracle Health, SMART on FHIR, or CDS Hooks, and the security and quality due diligence enterprise health systems perform on vendors
• 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
• ASQ CQE/CSQE, RAC, or equivalent quality or regulatory certification

Benefits

• Medical, Dental & Vision: Coverage through Anthem Blue Cross Blue Shield, including an HSA-eligible option, plus dental and vision through Guardian/VSP. Bayesian covers the majority of your premium and a meaningful share of your dependents’ coverage. Enrolled members also get access to One Medical for same-day and 24/7 virtual primary care.
• Life & Disability: Life insurance, short-term disability, and long-term disability, fully company-paid.
• 401(k): Company retirement plan with your choice of investment approach.
• Wellbeing: Free mental health support through Spring Health, plus additional wellness resources including pet care benefits.
• Time Off: Generous PTO that grows with tenure, paid sick time, paid holidays, and occasional company-wide self-care days.
• Equity: Equity grant so you share directly in what we build together.
• Team Retreats: Fully paid annual company retreat to connect with the team in person.
• Equipment: Your choice of Mac hardware, a one-time home office stipend, and ongoing reimbursement for internet and phone costs.

Company Culture

Bayesian is a small, mission-driven team building AI tools that help clinicians catch life-threatening conditions earlier. The team works remotely but stays closely connected in real time, believing that closer collaboration helps move faster for the hospitals and patients who depend on them.

Values that guide daily work:

• Patients at the center — hold ourselves to a high bar for excellence and impact
• Hard problems, real breakthroughs — pursue new ideas even when it’s uncomfortable
• No surprises, clear signals — communicate clearly and honestly so teams and customers can trust us
• Whole people, shared respect — treat teammates with respect and make space to grow
• Truth seekers, stronger together — debate openly and align around shared goals

Job Details

Team: Quality & Regulatory | Reports to: Head of Quality & Regulatory | Level: Senior individual contributor | Employment: Full-Time with Benefits | FLSA Status: Exempt | Location: Remote — US Only | Salary: $142,768 – $161,901 (candidates in certain high-cost cities may be eligible for a geographic premium) | Equity: