Overview

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

ABOUT THE ROLE:

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.

Responsibilities

WHAT YOU'LL DO:

Design Assurance Leadership:

• 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.

Risk Management:

• 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.

Technical Authority:

• 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 compliant.

Cross-Functional Engagement:

• Partner closely with R&D, Regulatory Affairs, Clinical, Manufacturing, and other cross-functional teams to align on design, quality, risk, and compliance requirements throughout product development.
• Act as the primary Quality representative within development teams for complex or high-visibility programs, building trusted partnerships that support timely, informed decision-making.
• Influence cross-functional teams to incorporate quality principles throughout the product lifecycle, promoting shared ownership of product excellence and continuous improvement.

Problem Solving & Issue Resolution:

• Lead the resolution of complex, ambiguous, or high-impact product and quality issues through data-driven analysis, sound engineering judgment, and cross-functional collaboration.
• Support system-level investigations involving field issues, design-related failures, customer feedback, and regulatory inquiries to ensure timely and effective resolution.
• Provide technical leadership in identifying root causes, developing appropriate corrective and preventive actions, and implementing sustainable solutions that strengthen product quality and organizational learning.

Other:

• Perform other duties and responsibilities as assigned by leadership in support of departmental and organizational objectives.

Qualifications

WHAT YOU'LL BRING:

Education:

• Bachelor's degree in engineering, Life Sciences or related field or relative experience.

Experience:

• 10+ years' experience in medical device design quality assurance in related field with demonstrated expertise in design controls, risk management and regulatory compliance for Class III implantable devices.

Skills/Competencies:

• Experience Deep understanding of design control requirements (QMSR (21 CFR Part 820), ISO 13485 and risk management - ISO 14971).
• Strong experience developing and executing verification and validation strategies.
• Ability to evaluate complex technical data and make sound, risk-based decisions.
• Proven ability to influence without authority and drive alignment across cross-functional teams.

WHAT WE OFFER:

At Endologix, we know that great work starts with great people - and people do their best when they feel valued and supported. That's why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You'll be part of a team that's making a real impact on patients' lives. When you join us, you're not just taking a job, you're building a meaningful career with a team that's invested in your success.

The compensation package includes:

• Base salary of $135,000-$157,500/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 that is available for Exempt employees)
• 401(k) retirement plan with company match

Plus:

• Flexible work arrangements, such as hybrid or remote work for many of our positions
• Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
• Employee recognition programs and awards
• Commuter benefits or transportation stipends