MEACOR · 4 months ago
Senior R&D Engineer – Implant/Clinical, Structural Heart Division
Irvine, CA
Full-time
Onsite
Senior Level
$130K/yr - $170K/yr
7+ years expMeacor Inc. is pioneering the future of valvular repair with innovative transcatheter devices. The Senior R&D Engineer will develop and validate next-generation mitral and tricuspid valve repair devices, focusing on design verification strategies and collaboration with clinical teams.
Health CareMedical Device
Responsibilities
Define and execute design verification strategies, including test methods, custom fixtures, and equipment
Develop and maintain product specifications to ensure compliance with engineering requirements and clinical use cases
Interpret medical imaging and collaborate with physicians to translate clinical insights into actionable engineering solutions
Partner with manufacturing to establish scalable, reproducible processes and support transfer into a cleanroom environment
Contribute to preclinical, regulatory, and clinical trial activities by supporting testing, documentation, and submissions in accordance with ISO 5840, ISO 5910, FDA, and EU MDR requirements
Prepare high-quality technical documentation and communicate results to internal teams and external stakeholders
Establish internal standards and inspection methods for components and final devices to ensure consistent quality
Qualification
Required
Bachelor of Science in Engineering required; advanced degree preferred
7+ years of engineering experience, including direct work with structural heart implants; annuloplasty experience strongly preferred
Proficiency in CAD software (SolidWorks preferred) for 3D design and technical drawings
Deep understanding of cardiac anatomy, clinical workflows, and imaging modalities (echocardiography, fluoroscopy); prior cath lab or physician interface experience desirable
Hands-on experience with design, prototyping, and collaboration on manufacturing methods (3D printing, machining/lathe, laser welding) within a QMS
Experience supporting regulatory submissions (FDA IDE/PMA, EU MDR) and contributing to pre-clinical or early clinical trial activities is highly desirable
Familiarity with testing standards such as ISO 5840 and ISO 5910
Working knowledge of statistical techniques such as design of experiments (DOE), tolerance analysis, and verification testing
Strong documentation, communication, and interpersonal skills, with the ability to collaborate effectively across technical teams and with clinicians
Benefits
Equity participation
Comprehensive benefits (health, dental, vision, 401(k), and paid time off)
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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