MEACOR · 3 days ago
Principal Quality Engineer
Irvine, CA
Full-time
Onsite
Lead/Staff
$160K/yr - $195K/yr
8+ years expMeacor is pioneering the future of valvular repair with a novel transcatheter device. They are seeking a Principal Quality Engineer to lead quality functions and ensure safety and regulatory success of their innovative products.
Health CareMedical Device
Responsibilities
Serve as the lead Quality representative on cross-functional product development teams, providing expert guidance on design controls and regulatory requirements
Lead the execution of the Risk Management process (ISO 14971), including the development of DFMEAs, UFMEAs, and Hazard Analyses for our novel transcatheter platform
Design and oversee robust Verification and Validation (V&V) protocols. You won't just approve them; you will help define the test methods, sample sizes, and statistical rationales
Develop and validate sophisticated test methods for our unique adhesion technology and mechanical delivery systems
Drive the creation and organization of the Design History File, ensuring it is audit-ready for upcoming IDE/PMA or CE Mark submissions
Lead complex technical investigations into design failures or bench-testing non-conformances, using advanced problem-solving methodologies
Provide technical oversight for critical suppliers, ensuring their manufacturing processes meet Meacor's rigorous standards for high-stakes structural heart components
Qualification
Required
8–12+ years of hands-on quality engineering experience in the medical device industry
Deep experience in Structural Heart, Interventional Cardiology, or complex Catheter-based systems is essential
A track record of taking complex Class III devices through the full development lifecycle, from concept to clinical trials
Advanced knowledge of statistical techniques (e.g., Gage R&R, Cpk, DOE, sampling plans)
Someone who enjoys being in the lab, understanding the 'how and why' behind a component failure
Expert-level command of ISO 13485, 21 CFR 820, and ISO 14971
Bachelor's or advanced degree in Mechanical, Biomedical, or Materials Engineering
Benefits
401k
Medical insurance
Company
MEACOR
MeaCor develops novel transcatheter devices for the treatment of heart disease.
2-10 employees
H1B Sponsorship
MEACOR 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 (1)
2024 (1)
Funding
Current Stage
Early StageTotal Funding
$15MKey Investors
MedTech Innovator
2024-05-14Series A· $15M
2022-06-07Non Equity Assistance
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