Staff Design Assurance Engineer

Endologix; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Endologix seeks a Sr. Design Assurance Engineer to join the Quality team at our Eden Prairie, MN site. You will own design control, V&V, and risk management activities across DVT and new product development to ensure safety, quality, and regulatory compliance.

You’ll work hands-on from day one, collaborating with R&D and manufacturing partners to embed quality into daily design practices and support successful product commercialization in vascular health.

Qualifications

• Experience executing design control per ISO 13485:2016.
• Experience with V&V planning, execution, and documentation.
• Strong understanding of 21 CFR Part 820 and QMS requirements.

Responsibilities

• Execute design control activities for product development programs.
• Develop, execute, and document V&V protocols and reports.
• Maintain design history files and related documentation for audit-readiness.
• Support design transfer activities to manufacturing processes.
• Collaborate with R&D and cross-functional teams to embed quality into development.

Skills

Design control

Regulatory compliance

Quality systems

Cross-functional collaboration

Job description

Overview

Join our innovative, mission-driven Quality team as a Sr. Design Assurance Engineer at Endologix!

WHO WE ARE:

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.

ABOUT THE ROLE:

The Sr. Design Assurance Engineer executes design assurance activities across product development programs at the Eden Prairie, MN site, with a primary focus on the Pounce product line and new product development. This role carries out design control, verification and validation (V&V), and risk management activities to ensure products meet safety, quality, and regulatory requirements.

This is a hands-on engineering role with ownership from day one and room to grow. The position reports directly to the Director, Design Assurance Engineering and works day to day with senior Quality and R&D team members on site. Strong performers will take on increasing independence and broader scope over time.

Responsibilities

WHAT YOU'LL DO:

Design Assurance Execution

• Execute design control activities for assigned product development programs, ensuring compliance with ISO 13485:2016, QMSR (21 CFR Part 820), and other applicable regulatory requirements while maintaining a strong commitment to quality, integrity, and patient outcomes.
• Support alignment between design inputs, outputs, and verification/validation activities to ensure products are developed with a focus on patient safety, performance, innovation, and regulatory compliance.
• Develop, execute, and document V&V protocols and reports in support of established V&V strategies, ensuring accurate and transparent documentation.
• Support design transfer activities by helping translate quality requirements into manufacturing processes to enable successful commercialization and consistent product performance.
• Maintain design history files and related documentation so they are accurate, complete, and audit-ready, demonstrating a commitment to quality and accountability.
• Partner with R&D and cross-functional teams to embed quality principles into day-to-day design and development activities, fostering a culture of collaboration and continuous improvement.