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Quality Engineer, Senior Staff (Risk Management) jobs in United States
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EnChannel Medical LTD · 17 hours ago

Quality Engineer, Senior Staff (Risk Management)

positionIrvine, CA
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
date8+ years exp
EnChannel Medical is redefining the boundaries of electrophysiology with their next-generation DePolar™ mapping system. The Quality Engineer, Senior Staff (Risk Management) role will focus on structuring the Design History File and strengthening product risk management while collaborating with R&D to ensure FDA-ready documentation and controls.
BiotechnologyHealthcareMedicalTherapeutics
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H1B Sponsor Likelynote

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

Qualification

Quality EngineeringRisk ManagementDesign Controls RemediationMedical Devices ExperienceCollaboration SkillsAdaptability

Required

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

Company

EnChannel Medical LTD

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Founded in 2020 by a team of seasoned electrophysiology innovators from both the United States and China, EnChannel Medical is developing a holistic platform that unifies magnetic-impedance navigation, intracardiac echocardiography, full-chamber 5D action-potential mapping, and mid-voltage (<1000 V) pulsed-field ablation to deliver safe and personalized treatment for patients with atrial fibrillation.
dateFounded in 2020
location
Huangpu, Guangdong, CHN
people-size11-50 employees
web-link
https://www.enchannel.com/

H1B Sponsorship

EnChannel Medical LTD has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)

Funding

Current Stage
Growth Stage
Total Funding
$110.2M
Key Investors
Lilly Asia Ventures,Longzhu CapitalLilly Asia Ventures,Longpan Investment
2025-04-23Series B· $82.34M
2023-08-01Series A· $27.86M

Leadership Team

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Jun Feng
CEO & Co-Founder
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Min Zhu
Chief Technology Officer
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Recent News

PR Newswire
EnChannel Medical to Acquire Acutus Medical AcQMap™ Electrophysiology Assets
2025-07-01
PEdaily.cn
Xinhanglu Medical completed RMB 600 million in Series B financing, led by Meituan Dragon Ball Fund and Lilly Asia Ventures
2025-05-08
Canada NewsWire
EnChannel Medical Raises $82.2M in Oversubscribed Series-B Financing to Advance Full-Chamber 5D Atrial Fibrillation Mapping and Personalized Pulsed-Field Ablation Therapy
2025-05-01
Company data provided by crunchbase