Senior Design Quality Engineer

Remote · USD 142,768-161,901 · 5+ years experience · Full-time · Remote · Posted Oct 1, 2026

At a glance

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.
This role intentionally wears multiple hats, requiring you to engineer quality into software as it's built, handle the post-market side in production, and keep the QMS and regulatory obligations current.
You work directly with engineering, data science, clinical, and implementation teams under the direction of the Head of Quality and Regulatory.

Partner with engineering and data science through the full software lifecycle 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.
Assess software and model changes for regulatory impact and drive the change through the quality management system.
Support complaint intake, triage, investigation, and closure, while preparing MDR reportability assessments under 21 CFR 803.
Lead nonconformance reports and CAPAs when patterns emerge from trended complaints and field data.
Maintain and update quality procedures, document control, training records, and compliance evidence, and manage supplier controls.
Contribute to 510(k)s, Q-Submissions, and Predetermined Change Control Plans, responding to FDA questions and supporting inspections.
Monitor FDA guidance on AI/ML-enabled devices, cybersecurity under Section 524B, and quality system expectations.
Embed compliance into product, engineering, and commercial workflows and communicate quality metrics to technical and non-technical audiences.

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 with the ability to produce audit-ready records and explain regulatory concepts to diverse stakeholders
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

Medical, Dental & Vision coverage through Anthem Blue Cross Blue Shield, Guardian, and VSP
Access to One Medical for same-day and 24/7 virtual primary care
Fully company-paid life insurance, short-term disability, and long-term disability
Company retirement plan (401(k)) with choice of investment approach
Free mental health support through Spring Health and wellness resources including pet care benefits
Generous PTO, paid sick time, paid holidays, and occasional company-wide self-care days
Equity in the company
Fully paid annual company retreat
Choice of Mac hardware, one-time home office stipend, and ongoing reimbursement for internet and phone costs

Remote - US Only
Candidates based in certain high-cost cities may be eligible for a geographic premium.

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