OverviewJoin our innovative, mission-driven Quality team as a Sr. Design Assurance Engineer at Endologix!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.
ResponsibilitiesWHAT 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.
Risk Management- Conduct product risk management activities in accordance with ISO 14971 principles across the product lifecycle, from concept through post-market surveillance, with a focus on protecting patient safety and product quality.
- 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 to support responsible product development.
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 throughout product development and commercialization.
- Represent Quality within development teams for assigned programs, supporting timely, informed decision-making and helping drive successful project outcomes.
- 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 that drive continuous improvement and organizational learning.
Other- Perform other duties and responsibilities as assigned by leadership in support of departmental objectives, organizational success, and Endologix's commitment to improving patient lives through innovation, quality, and collaboration.
QualificationsWHAT YOU'LL BRING: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.
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 $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 that is available for Exempt employees)
- 401(k) retirement plan with company match
Plus:
- Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
- Employee recognition programs and awards
- Commuter benefits or transportation stipends
