Director Of Quality

Company: Meacor Inc. - Irvine, CA (Onsite) Director of Quality – Implant, Structural Heart Division About Meacor: Meacor is pioneering the future of valvular repair with a truly novel transcatheter device that leverages groundbreaking on‑demand adhesion technology. We're not just improving existing solutions; we're building something fundamentally new to address critical patient needs. Fresh off a successful Series A funding round, we have the momentum and resources to accelerate development and bring this innovative platform to life. Located in the vibrant medical device hub of Irvine, California, our team thrives in a dynamic environment supported by robust in‑house prototyping and manufacturing capabilities. The Opportunity: We are searching for a high‑caliber Director of Quality to be the technical anchor of our quality function. This is not a "desk job" overseeing paperwork; it is a critical technical role for a subject matter expert who thrives on solving complex engineering challenges through a quality lens. As a Principal Engineer, you will be the primary architect of our Design History File (DHF) and the lead strategist for our Risk Management efforts. You will work side‑by‑side with our R&D team to ensure that our novel adhesion technology, complex delivery systems, and control consoles are built for safety, reliability, and regulatory success from the ground up. What You’ll Do: Technical Quality Lead: Serve as the lead Quality representative on cross‑functional product development teams, providing expert guidance on design controls and regulatory requirements. Risk Management Ownership: Lead the execution of the Risk Management process (ISO 14971), including the development of DFMEAs, UFMEAs, and Hazard Analyses for our novel transcatheter platform. V&V Strategy: 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. Test Method Validation (TMV): Develop and validate sophisticated test methods for our unique adhesion technology and mechanical delivery systems. DHF Management: Drive the creation and organization of the Design History File, ensuring it is audit‑ready for upcoming IDE/PMA or CE Mark submissions. Root Cause Analysis: Lead complex technical investigations into design failures or bench‑testing non‑conformances, using advanced problem‑solving methodologies. Supplier Partnership: Provide technical oversight for critical suppliers, ensuring their manufacturing processes meet Meacor's rigorous standards for high‑stakes structural heart components. What We’re Looking For: Experience: 12+ years of hands‑on quality engineering experience in the medical device industry. Domain Expertise: Deep experience in Structural Heart, Interventional Cardiology, or complex Catheter‑based systems, Electromechanical Console is essential. The "Principal" Mindset: A track record of taking complex Class III devices through the full development lifecycle, from concept to clinical trials. Statistical Mastery: Advanced knowledge of statistical techniques (e.g., Gage R&R, Cpk, DOE, sampling plans). Hands‑on Problem Solver: Someone who enjoys being in the lab, understanding the "how and why" behind a component failure. Regulatory Fluency: Expert‑level command of ISO 13485, 21 CFR 820, and ISO 14971. Education: Bachelor’s or advanced degree in Mechanical, Biomedical, or Materials Engineering. Why Join Meacor? Directly Influence Innovation: Be the technical lead ensuring a first‑of‑its‑kind adhesion technology reaches patients safely. High Visibility: In our lean startup environment, your technical expertise will be recognized and relied upon by the executive team daily. Rapid Iteration: Work in an environment where your feedback directly changes the design of the device in real‑time. Competitive Package: Receive a market‑based salary ( $180,000 to $215,000 ) and meaningful equity as a key technical stakeholder, in addition to typical benefits, 401k and medical insurance. #J-18808-Ljbffr