Director of Quality - Structural Heart

Director of Quality - Structural Heart Innovator

Location: On-site - Southern CA

Comp: $200-$220k base + bonus and equity package + benefits

The Opportunity: We are looking for a Director of Quality to serve as the technical cornerstone of the quality function. This is not an oversight role — it's a hands-on engineering position for a subject matter expert who approaches complex technical challenges through a quality lens.

You will be the primary architect of the Design History File (DHF) and lead strategist for Risk Management, working directly alongside R&D to ensure the adhesion technology, delivery systems, and control console are built for safety, reliability, and regulatory success from day one.

What You'll Do:

• Technical Quality Lead: Serve as the senior quality voice on cross-functional development teams, providing expert guidance on design controls and regulatory requirements throughout the product lifecycle.
• Risk Management Ownership: Own and execute the Risk Management process (ISO 14971), including DFMEAs, UFMEAs, and Hazard Analyses across a novel transcatheter platform.
• V&V Strategy: Define and oversee Verification and Validation protocols — not just approve them. You will shape the test methods, sample sizes, and statistical rationales.
• Test Method Validation (TMV): Develop and validate sophisticated test methods for a unique adhesion technology and complex mechanical delivery systems.
• DHF Management: Lead the creation and ongoing governance of the Design History File, maintaining audit-readiness for IDE/PMA and CE Mark submissions.
• Root Cause Analysis: Drive technical investigations into design failures and bench-testing non-conformances using rigorous problem-solving methodologies.
• Supplier Oversight: Provide technical quality oversight for critical suppliers, ensuring manufacturing processes meet exacting 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 background in Structural Heart, Interventional Cardiology, or complex catheter-based systems.
• Principal Mindset: Demonstrated track record taking complex Class III devices through the full development lifecycle, from early concept through clinical trials.
• Statistical Fluency: Advanced command of statistical techniques including Gage R&R, Cpk, DOE, and sampling plan design.
• Lab Presence: A genuine preference for being in the lab — understanding the how and why behind a component failure, not just documenting it.
• Regulatory Expertise: Expert-level knowledge of ISO 13485, 21 CFR 820, and ISO 14971.
• Education: Bachelor's or advanced degree in Mechanical, Biomedical, or Materials Engineering.