Principal Design Assurance Engineer

Overview

Join our Quality team as the Principal Design Assurance Engineer at Endologix!

Endologix LLC is a California-based global medical device company dedicated to improving patients' lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training - supported by industry-leading clinical evidence.

At Endologix, we're driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health.

What sets us apart is not just our technology, but our culture. At Endologix, we foster a forward-thinking, mission-driven environment where every team member plays a vital role in advancing patient care. Our core values guide how we operate. As for our people? We empower them with the tools, trust, and continuous learning they need to grow. If you're passionate about making a meaningful difference in healthcare, you'll find purpose and belonging here.

Our Core Values are the guiding principles informing our choices and actions, because our customers and patients depend on us:

• Patient Outcomes Drive Us:
  We improve lives with every advancement we deliver.
• Integrity Defines Us:
  We do what's right, stay transparent, prioritize quality, and own our actions.
• Innovation Advances Us:
  We stay curious, adaptable, and push boundaries.
• Boldness Propels Us:
  We take smart risks and are unafraid in our pursuit of excellence.
• Collaboration Unites Us:
  We partner across teams and with physicians to drive exceptional results.

The Principal Design Assurance Engineer serves as a senior technical authority responsible for design assurance across product development programs. This role drives design control execution, verification and validation (V&V) strategy, and risk management to ensure products meet safety, quality, and regulatory requirements.

This position operates with a high degree of independence and is expected to influence cross-functional teams and drive decisions on complex or high-risk design topics. While not a people management role, it requires strong technical leadership and the ability to guide teams through ambiguity and critical design decisions.

WHAT YOU'LL DO:

• Lead design control execution for assigned product development programs, ensuring compliance with ISO 13485:2016, QMSR (21 CFR Part 820), and other applicable regulatory requirements while promoting a culture of quality, accountability, and continuous improvement.
• Drive alignment between design inputs, outputs, and verification/validation activities to ensure products are developed with a focus on patient safety, performance, and regulatory compliance.
• Establish and oversee verification and validation (V&V) strategies for complex and high-risk products, ensuring robust scientific and engineering practices throughout the development lifecycle.
• Provide strategic guidance on design transfer readiness, ensuring quality requirements are effectively translated into manufacturing processes to support successful commercialization.
• Serve as a subject matter expert on design control activities, providing guidance that enables compliant, efficient, and effective product development.
• Partner with R&D and cross-functional teams to embed quality principles into design and development processes, fostering collaboration, innovation, and operational excellence.

• Lead product risk management activities in accordance with ISO 14971 principles across all phases of the product lifecycle, from concept through post-market surveillance.
• Ensure risk management is proactively integrated into design, development, manufacturing, and post-market activities to support informed decision-making and long-term product success.
• Drive comprehensive hazard identification, risk analysis, and implementation of effective risk mitigation strategies while ensuring thorough and compliant documentation.
• Champion technically sound, risk-based decision making by balancing innovation, patient safety, product quality, and business objectives.

• Serve as the technical authority and key decision-maker on design quality, product risk, and compliance matters for complex development programs.
• Exercise independent judgment by challenging design decisions or program progression when quality, safety, or regulatory risks have not been sufficiently addressed.
• Provide expert technical leadership during design reviews, failure investigations, and critical program decisions to ensure robust engineering solutions and regulatory compliance.
• Serve as a key contributor to regulatory submissions, inspections, and audits by ensuring technical documentation is accurate, complete, and…