Sr. Design Assurance Engineer

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 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: improving patient outcomes, integrity, innovation, boldness, and collaboration.

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. 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.

Responsibilities

• 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.
  • 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.
  • Support design transfer activities by helping translate quality requirements into manufacturing processes to enable successful commercialization.
  • Maintain design history files and related documentation so they are accurate, complete, and audit-ready.
  • Partner with R&D and cross-functional teams to embed quality principles into day-to-day design and development activities.
• Risk Management
  • Conduct product risk management activities in accordance with ISO 14971 principles across the product lifecycle, from concept through post-market surveillance.
  • Support hazard identification, risk analysis, and implementation of effective risk mitigation strategies while ensuring thorough, compliant, and transparent documentation.
  • Apply risk-based thinking to engineering decisions, balancing innovation, patient safety, product quality, and business objectives.
• Cross-Functional Engagement
  • Partner with R&D, Regulatory Affairs, Clinical, Manufacturing, and other cross-functional teams to align on design, quality, risk, and compliance requirements.
  • Represent Quality within development teams for assigned programs, supporting timely, informed decision-making.
  • Proactively raise quality, safety, or compliance concerns and work collaboratively to support effective and timely resolution.
  • Support regulatory submissions, inspections, and audits by ensuring technical documentation is accurate, complete, compliant, and reflective of the highest standards of integrity.
• Problem Solving & Issue Resolution
  • Support the resolution of product and quality issues through data-driven analysis, sound engineering judgment, and cross-functional collaboration.
  • Contribute to investigations involving field issues, design-related failures, and customer feedback, leveraging insights to improve product performance and patient outcomes.
  • Support root cause identification and the development and implementation of corrective and preventive actions.
• Perform other duties and responsibilities as assigned by leadership in support of departmental objectives and organizational success.

Qualifications

Education
Bachelor’s degree in Engineering, Life Sciences, or related field, or equivalent experience.

Experience
3 to 5 years of experience in medical device design quality assurance or a closely related engineering role, with working knowledge of design controls, risk management, and regulatory compliance. Experience with catheter-based or vascular devices is a plus. Exposure to Class III devices and PMA pathways is helpful but not required.

Skills/Competencies

• Working knowledge of design control requirements, including QMSR (21 CFR Part 820), ISO 13485, and risk management under ISO 14971.
• Experience writing and executing verification and validation protocols and reports.
• Ability to evaluate technical data and support sound, risk-based decisions.
• Strong collaboration and communication skills across cross-functional teams.
• Self-directed and motivated; seeks out work, takes ownership, and follows through in a fast-moving, high-growth environment.

Benefits

• Base salary of $110,000-$127,500/year
• 10% Discretionary bonus
• Equity participation as approved by Board of Directors (4-year vesting schedule)
• Comprehensive health, dental, and vision insurance plans
• Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
• Generous paid time off (vacation, sick leave, holidays, and flexible time off for Exempt employees)
• 401(k) retirement plan with company match
• Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
• Employee recognition programs and awards
• Commuter benefits or transportation stipends