Quality Engineer, Senior Staff (Risk Management)
About The Position
Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes. Position Overview The Quality Engineer, Senior Staff (Risk Management) role will play a critical part in structuring the Design History File, strengthening product risk management, and partnering with R&D to translate existing development work into FDA-ready documentation and controls. This role will collaborate with cross-functional teams and engineers to implement complex maintainability expectations and drive a quality culture.
Requirements
- 8-12 years QE in medical devices
- Hands-on design controls remediation experience
- Risk management ownership experience
- Experience supporting submissions or inspections after gaps existed
- Comfortable in fast-paced, imperfect environments
Responsibilities
- Drive design controls remediation: DHF structure, missing documentation, review alignment
- Partner with R&D to convert existing development outputs into compliant design inputs, outputs, and verification evidence
- Identify gaps and prioritize IDE-critical documentation
- Support IDE submission readiness and audit preparedness
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
