Senior Design Quality Engineer

Bazeta; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Bayesian Health seeks a Senior Design Quality Engineer to own software design quality, risk management, and regulatory submissions for FDA-cleared AI clinical decision support. You will read code, analyze logs, and guide engineers through IEC 62304, ISO 14971, and 21 CFR 820; manage post-market surveillance and CAPAs; collaborate with cross-functional teams to keep the QMS current as we scale.

You will work under the Head of Quality and Regulatory to ensure complaint handling, change control,

Qualifications

• BS in Computer Science, Systems Engineering, Biomedical Engineering, or related 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.
• Experience with complaint handling and adverse event reportability decisions under 21 CFR 803 and 21 CFR 820, including CAPA.

Responsibilities

• Own software design quality across the full lifecycle with risk analysis, verification, validation, and release readiness per IEC 62304 and ISO 14971.
• Assess regulatory impact of changes, maintain risk files, and support post-market performance monitoring.
• Lead complaint handling, MDR trend analysis, CAPAs, and QMS improvements with cross-functional teams.

Skills

Code reading

Logs analysis

Regulatory knowledge

Written communication

Education

BS in Computer Science / Systems Engineering / Biomedical Engineering

Tools

IEC 62304

ISO 14971

21 CFR 820

21 CFR 803

Job description

4. Senior Design Quality Engineer# Senior Design Quality Engineer## DescriptionSenior Design Quality EngineerIn BriefWe'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 AreBayesian 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 RoleBayesian 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 OwnSoftware Design QualityPartner 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 LifecycleAssess 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 SurveillanceSupport 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 & MaintenanceMaintain 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 & SubmissionsContribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans. Respond to FDA questions and support the team during FDA inspections.Regulatory IntelligenceMonitor 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 CollaborationEmbed 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...Source: Jobicy (https://jobicy.com/jobs/154879-senior-design-quality-engineer)