Principal Quality Engineer

Company
:
Meacor Inc.

- Irvine, CA (Onsite)

• 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.

• Experience: 8–12+ 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 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.

• 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 ($160,000 to $195,000
  ) and meaningful equity as a key technical stakeholder, in addition to typical benefits, 401k and medical insurance.