[Hiring] Senior Design Quality Engineer @Bayesian Health, Inc.

Role Description

We're 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. You'll safeguard product quality for an FDA-cleared, AI-driven clinical platform, from design controls while we build, to complaint investigation once it's live in hospitals, to the quality system and regulatory record that hold it all together.

Bayesian ships FDA-cleared, AI clinical decision support software directly into Epic and Oracle Health workflows at health systems across the country. Every release, every model update, and every clinician report that an alert didn't behave as expected runs through a quality and regulatory system that has to be as rigorous as the software itself. You will help drive that system.

This role intentionally wears multiple hats. We're a small company, and we need one person who can do several things well:

• Engineer quality into the software as it's built.
• Handle the post-market side once it's in production.
• Keep the quality management system and our regulatory obligations current as we scale.

You'll work directly with engineering, data science, clinical, and implementation teams, with support from company leadership, while under the direction of the Head of Quality and Regulatory.

You're the engineer in the room on quality questions. When a hospital reports that the model flagged a patient late, you decide whether it's a complaint, whether it's reportable, and what changed in the software or the data. You can read the code, the logs, and the test evidence to find out.

Qualifications

• A 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.
• A track record of writing, maintaining, and improving QMS procedures, document control, and change management in a regulated software environment.
• The 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. You produce audit-ready records and can explain regulatory concepts to engineers, clinicians, and executives without losing precision.
• A 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.

Requirements

• 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.
• 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.
• Complaint Handling & Post-Market Surveillance: Support complaint intake, triage, investigation, and closure. Prepare MDR reportability assessments under 21 CFR 803 for review and approval.
• QMS Improvement & Maintenance: Maintain and update quality procedures, document control, training records, and compliance evidence as the company grows.
• 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.
• Cross-Functional Collaboration: Embed compliance into how product, engineering, and commercial teams already work, so that quality speeds delivery rather than slowing it down.

Benefits

• Medical, Dental & Vision: Coverage through Anthem Blue Cross Blue Shield, including an HSA-eligible option, plus dental and vision through Guardian/VSP.
• Life & Disability: Life insurance, short-term disability, and long-term disability, fully company-paid.
• 401(k): A 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 and more.
• Time Off: Generous PTO that grows with tenure, paid sick time, paid holidays, and occasional company-wide self-care days.
• Equity: You'll also receive equity, so you share directly in what we build together.
• Team Retreats: A 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.