Bayesian Health, Inc. - Senior Design Quality Engineer
Requirements
• 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 • 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 • Life at Bayesian • We're a small, mission-driven team building AI tools that help clinicians catch life-threatening conditions earlier. We work remotely but stay closely connected in real time. We believe that closer collaboration helps us move faster for the hospitals and patients who depend on us. • Our values guide how we work every day: • Patients at the center. We hold ourselves to a high bar for excellence and impact. • Patients at the center. • Hard problems, real breakthroughs. We pursue new ideas even when it's uncomfortable. • Hard problems, real breakthroughs. • No surprises, clear signals. We communicate clearly and honestly, so teams and customers can trust us. • No surprises, clear signals. • Whole people, shared respect. We treat teammates with respect and make space to grow. • Whole people, shared respect. • Truth seekers, stronger together. We debate openly and align around shared goals. • Truth seekers, stronger together.
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. • Medical, Dental & Vision: • Life & Disability: Life insurance, short-term disability, and long-term disability, fully company-paid. • Life & Disability: • 401(k): A company retirement plan with your choice of investment approach. • 401(k): • Wellbeing: Free mental health support through Spring Health, plus additional wellness resources including pet care benefits and more. • Wellbeing: • Time Off: Generous PTO that grows with tenure, paid sick time, paid holidays, and occasional company-wide self-care days. • Time Off: • Equity: You'll also receive equity, so you share directly in what we build together. • Equity: • Team Retreats: A fully paid annual company retreat to connect with the team in person. • Team Retreats: • Equipment: Your choice of Mac hardware, a one-time home office stipend, and ongoing reimbursement for internet and phone costs. • Equipment: • Team: Quality & Regulatory • Team: • Reports to: Head of Quality & Regulatory • Reports to: • Level: Senior individual contributor • Level: • Employment Classification: Full-Time with Benefits • Employment Classification: • FLSA Status: Exempt • FLSA Status: • Location: Remote - US Only • Location: • Candidates based in certain high-cost cities may be eligible for a geographic premium. • Equity: Eligible • Equity: • Synchronous Hours: 11a-5p ET (8a-2p PT) • Synchronous Hours:
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