Senior Design Quality Engineer

Senior Design Quality Engineer

In Brief

We'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.

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 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 the implementation and clinical teams, who hear from clients first, to make sure 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.

What You'll Bring

• 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

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 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
• An ASQ CQE/CSQE, RAC, or equivalent quality or regulatory certification

What We Offer

• 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): 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.

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)