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java test automation python ci/cd fhir📋 Description
- Staff-level SQ Engineer for enterprise imaging platform.
- Own quality and validation across the full SDLC.
- Develop automation and testing strategies for APIs.
- Ensure regulatory and SaMD compliance with traceability.
- Lead test asset creation and regression testing.
- Partner with engineering/regulatory teams for QMS.
🎯 Requirements
- 10+ years regulated SQA for SaMD; V&V; FDA submissions; BS in CS/Engineering.
- SDET-level: Python, Java, or C# for automation/APIs.
- Regulatory DevOps: Traceability-as-Code, automated compliance in CI/CD.
- Standards & Interop: DICOM/HL7/FHIR; ISO13485/IEC62304; DICOM-SR + SaMD security.
- Audit & Change Mgmt: Change control, impact analysis, audit-ready docs.
- Cross-functional leadership: bridge Eng, Clinical, Regulatory; define Definition of Done.
🎁 Benefits
- Mostly remote work with offices in Denver, New York, Dallas, Lisbon.
- Travel may be required for some roles; typically monthly or quarterly.
- Core values: Humility, Excellence, Accountability, Remarkable, Teamwork.
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