Senior Design Quality Engineer
Company hidden · Remote · USA ·
COMPENSATION
Salary available to subscribersListed on Jobicy
- Fully remote (US only)
- Senior level role
- FDA-cleared AI platform
- ISO 13485 & IEC 62304
- No visa sponsorship
The company builds AI-driven clinical decision support tools integrated into Epic and Oracle Health workflows. This role ensures product quality from design through post-market surveillance, managing regulatory compliance for an FDA-cleared platform.
You will partner with engineering and data science teams to maintain design history files, handle complaint investigations, and drive change control processes. The position requires balancing rigorous regulatory obligations with agile software development in a remote-first environment.
What you'll do
- Manage design controls including risk analysis, verification, and validation per IEC 62304
- Assess software and model changes for regulatory impact and drive change control
- Handle complaint intake, triage, investigation, and MDR reportability assessments
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