Senior Design Quality Engineer

Bayesian Health

. 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 .

Posted 10/2/2026full-timeRemote • United StatesSenior💰 $142,768 - $161,901 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in software quality engineering and regulatory compliance for medical devices, with a strong focus on ISO 13485, IEC 62304, and FDA regulations. Capable of managing design controls, risk management, and quality management systems while effectively communicating with technical and non-technical stakeholders.

Highest-signal resume keywords

ISO 13485 ComplianceIEC 62304 Risk ManagementFDA Regulatory ExperienceQuality Management System (QMS) ProceduresComplaint Handling and CAPA

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software Quality EngineeringRegulatory ComplianceDesign ControlsRisk ManagementComplaint InvestigationAdverse Event ReportingChange ManagementCode ReviewAutomated TestingCybersecurity Standards

Soft Skills

Excellent Written CommunicationProcess-Fixer MindsetAbility to Learn QuicklyClear Communication

Tools & Technologies

EQMS PlatformsJiraCloud-Based SaaSEHR SoftwareAutomated Testing Tools

Certifications & Qualifications

ASQ CQEASQ CSQERAC

Industry Keywords

Medical DevicesQuality Management System Regulations510(k) SubmissionsFDA InspectionsAI/ML-Enabled Devices

Tech Stack

Tools & technologies

CloudCyber SecurityOracle

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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