Senior Design Quality Engineer

The posting, as Bayesian Health, Inc. wrote it

SENIOR DESIGN QUALITY ENGINEER

IN BRIEF

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.

WHO WE ARE

Bayesian Health's mission is to improve patient outcomes by empowering clinicians with the insights they need to make the right decision for the right patient at the point of care. We're a diverse team of clinicians, engineers, AI experts, product designers, and performance improvement leaders committed to enabling smarter, patient-specific care delivery through unlocking the power of data.

We're funded by top tier tech and biotech investors: Obvious Ventures, Andreessen Horowitz, 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. Read more about our peer-reviewed research in Nature Medicine associating our products with improved patient outcomes.

ABOUT THE ROLE

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, and 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.

WHAT YOU'LL OWN

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
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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.

Team: Quality & Regulatory

Reports to: Head of Quality & Regulatory

Level: Senior individual contributor

Employment Classification: Full-Time with Benefits

FLSA Status: Exempt

Location: Remote - US Only

Salary: $142,768 - $161,901

Candidates based in certain high-cost cities may be eligible for a geographic premium.

Equity: Eligible

Synchronous Hours: 11a-5p ET (8a-2p PT)

Bayesian Health provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Bayesian Health is committed to providing reasonable accommodations to qualified individuals, including for disability, pregnancy-related conditions, and religious practice. If you need accommodation during the application or interview process, contact careers@bayesianhealth.com.

Candidates must have current, unrestricted authorization to work in the United States. Bayesian Health does not provide visa sponsorship for this position. Bayesian Health participates in E-Verify.

This job posting describes the general nature of the role. Employment with Bayesian Health, if offered, is at-will, and duties may evolve over time.