Senior Design Quality Engineer

Job not on LinkedIn

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $142.8k - $161.9k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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Bayesian Health

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

Healthcare • Artificial Intelligence • Healthcare Insurance

Bayesian Health is a healthcare technology company that focuses on transforming healthcare data into actionable clinical insights through its adaptive AI platform. The platform enables Intelligent Care Augmentation, allowing caregivers to deliver proactive and higher quality care, ultimately resulting in improved patient health outcomes. With a foundation of extensive research in the field, Bayesian Health aims to empower physicians and care teams with real-time data to enhance decision-making and save lives.

📋 Description

• Partner with engineering and data science across the full software lifecycle, including requirements, architecture review, software risk analysis, verification and validation, traceability, and release readiness • Maintain the design history file and risk management file in accordance with IEC 62304, ISO 14971, and 21 CFR 820 (QMSR) design controls • Assess software and model changes for regulatory impact and determine whether a letter-to-file or new submission applies • Drive changes through the quality management system • Maintain the risk file and support post-market performance monitoring of deployed algorithms • Support complaint intake, triage, investigation, and closure • Prepare MDR reportability assessments under 21 CFR 803 for review and approval • Trend complaints and field data • Lead nonconformance reports and CAPAs when patterns emerge • Ensure feedback from implementation and clinical teams reaches the quality system • Maintain and update quality procedures, document control, training records, and compliance evidence • Support internal audits and prepare management review inputs • Manage supplier controls for EHR, cloud, and subcontractor relationships • Contribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans • Respond to FDA questions and support FDA inspections • Monitor FDA guidance on AI/ML-enabled devices, cybersecurity under Section 524B, and quality system expectations • Translate emerging regulatory requirements into changes to procedures and product requirements • Embed compliance into product, engineering, and commercial workflows • Communicate quality metrics and risk to technical and non-technical audiences, including executives • Work directly with engineering, data science, clinical, and implementation teams under the direction of the Head of Quality and Regulatory

🎯 Requirements

• 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 • 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) • Experience with complaint investigation, trending, and CAPA • Track record of writing, maintaining, and improving QMS procedures, document control, and change management in a regulated software environment • Ability to read code, logs, and automated test results to investigate software issues independently • 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 and ability to produce audit-ready records and explain regulatory concepts precisely to engineers, clinicians, and executives • High drive, process-fixer mindset, ability to learn quickly, and clear communication • Current, unrestricted authorization to work in the United States • Nice to have: Experience with AI/ML-enabled medical devices, algorithm change control, Predetermined Change Control Plans, model performance monitoring, and FDA AI/ML guidance • Nice to have: Experience preparing 510(k)s or Q-Submissions and corresponding with FDA reviewers • Nice to have: Familiarity with EHR-integrated software such as Epic or Oracle Health, SMART on FHIR, or CDS Hooks • Nice to have: Experience supporting FDA inspections, ISO 13485 certification audits, or customer audits • Nice to have: Experience with eQMS platforms, Jira-based defect tracking, and computerized system validation • Nice to have: ASQ CQE/CSQE, RAC, or equivalent quality or regulatory certification • Must work synchronously during 11a–5p ET (8a–2p PT) hours • Visa sponsorship is not provided

🏖️ Benefits

• Medical, dental, and vision coverage through Anthem Blue Cross Blue Shield, Guardian, and VSP • HSA-eligible medical option • Company-paid life insurance, short-term disability, and long-term disability • 401(k) company retirement plan • Free mental health support through Spring Health • Wellness resources, including pet care benefits • Generous PTO that grows with tenure • Paid sick time • Paid holidays • Occasional company-wide self-care days • Equity • Fully paid annual company retreat • Choice of Mac hardware • One-time home office stipend • Ongoing reimbursement for internet and phone costs • Remote work arrangement • Geographic premium eligibility for candidates in certain high-cost cities