Design Assurance Engineer (Hybrid - San Diego, CA)
Insulet(2 months ago)
About this role
This role drives Quality Assurance and Quality Engineering activities across the software development lifecycle for medical device products and automated quality-system data processing. The position ensures software development and cybersecurity processes comply with applicable standards and regulatory guidance for FDA Class II/III devices. The role interfaces with cross-functional teams and external parties to support product development, launched product support, and quality-system software.
Required Skills
- Design Control
- Software Validation
- Risk Management
- IEC 62304
- ISO 13485
- Verification
- Requirements Tracing
- Cybersecurity
- Test Planning
- Configuration Management
+2 more
Qualifications
- BS Degree
- Master's Degree
- ASQ
- CSQE
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