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Bayesian HealthSenior Design Quality Engineer
Bayesian Health is hiring a Senior Design Quality Engineer to guard the quality of an AI-driven clinical decision support product that carries FDA clearance. The role…
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About This Role
Bayesian Health is hiring a Senior Design Quality Engineer to guard the quality of an AI-driven clinical decision support product that carries FDA clearance. The role spans design controls during development, complaint investigation after the product reaches hospitals, and the quality system and regulatory file that hold it together. Bayesian describes itself as a fast-growing startup that gives physicians, nurses and care teams real-time data to inform care. Its software…
Job Description
Bayesian Health is hiring a Senior Design Quality Engineer to guard the quality of an AI-driven clinical decision support product that carries FDA clearance. The role spans design controls during development, complaint investigation after the product reaches hospitals, and the quality system and regulatory file that hold it together.
Bayesian describes itself as a fast-growing startup that gives physicians, nurses and care teams real-time data to inform care. Its software runs inside Epic and Oracle Health environments used by health systems nationwide. The role is a senior individual contributor position in Quality and Regulatory, and the reporting line goes to the company's head of quality and regulatory. The posting lists it as remote within the United States only.
The job has several parts. The person helps build quality into software and model changes as they happen, handles post-market matters such as complaints and reportability decisions, and keeps the quality management system and regulatory obligations current as the company grows. The posting expects candidates to read code, logs and test output well enough to troubleshoot software problems alongside engineers.
The company points to outside research published in a major medical journal that links its products to better patient results, and says its team includes clinicians, engineers, AI experts and performance improvement leaders.
Responsibilities
- Support the software lifecycle from requirements through release readiness under IEC 62304, ISO 14971 and the design controls of 21 CFR 820 (QMSR)
- Maintain the DHF and risk file so they stay current and hold up to scrutiny
- Judge the regulatory impact of software and algorithm updates, choosing between a letter to file and a new submission
- Help run complaints from intake through to closure, and draft reportability decisions for MDRs grounded in 21 CFR 803
- Spot trends in complaints and field data, and take charge of nonconformance reports and CAPAs if recurring issues appear
- Keep quality procedures, document control and training records current, and oversee vendors for EHR platforms, cloud hosting and subcontractors
- Work on FDA submission packages for 510(k) clearances, Q-Submissions and PCCPs, and support FDA inspections
- Follow updates on how the FDA treats machine learning devices and on Section 524B cybersecurity rules
Requirements
- A bachelor's degree in CS, systems engineering, biomedical engineering or similar technical training, or equivalent hands-on experience
- Minimum of five years in quality or regulatory roles for software medical devices, covering ISO 13485 and IEC 62304
- Practical experience owning design controls and the ISO 14971 risk files
- Background handling complaints and deciding adverse event reportability under 21 CFR 803 and 820
- Proven ability to write and improve QMS procedures and to run controlled change in regulated software settings
- Can follow code, system logs and test output closely enough to diagnose software problems
- Familiar with premarket cybersecurity requirements under Section 524B, from threat modeling through SBOM upkeep and handling vulnerabilities
- Excellent written communication and current, unrestricted US work authorization
Qualifications
- Work history with machine learning medical devices, algorithm change control and model performance tracking
- Hands-on work preparing 510(k) files or Q-Submissions and communicating with FDA reviewers
- Knowledge of EHR-connected tools like Epic or Oracle Health, plus SMART on FHIR and CDS Hooks standards
- Experience backing up the primary contact during FDA inspections, customer audits or ISO 13485 certification reviews
- Experience with eQMS platforms, Jira and computerized system validation
- ASQ CQE or CSQE, or RAC, or any comparable quality or regulatory credential
Core Skills
Benefits
- Medical, dental and vision plans, including an HSA-eligible option, with most of the premium covered by the company
- Fully company-paid life insurance, plus short- and long-term disability cover
- 401(k) retirement plan, a Spring Health mental health service at no cost, and pet care perks
- PTO that increases the longer you stay, paid sick leave, paid holidays and a few company-wide days off
- Equity, an annual in-person team retreat paid by the company, and your choice of Mac hardware
- A home office stipend once, and ongoing help covering internet and phone bills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this role remote?
The posting lists it as remote, US only. Synchronous hours run from 11 AM to 5 PM Eastern, which is 8 AM to 2 PM Pacific.
What is the base salary?
The posting gives a base salary of USD 142,768 to 161,901 and says the role is equity eligible. Some candidates in pricier metro areas could receive an added geographic premium.
Does the company sponsor visas for this role?
No. Bayesian states it will not sponsor visas for this job, and applicants need current, unrestricted US work authorization.
Does the posting describe the interview process?
No. The posting does not describe the application or interview steps.
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