Position: Staff Design Assurance Engineer

Department: Quality

Location: Eden Prairie, MN

WHO WE ARE:

Endologix LLC operates as a is a subsidiary of Rhevera Medical Holdings, LLC, a global medical device company focused on preserving and restoring the blood flow patients depend on. Our innovative vascular portfolio spans aortic repair, peripheral arterial disease, and thrombectomy, including the ALTO® Abdominal Stent Graft System, AFX®2 Endovascular AAA System, DETOUR™ System, and Pounce™ Thrombectomy System.

At Rhevera Medical, innovation is more than what we create. It’s how we think, collaborate, and move patient care forward. We’re building a mission-driven culture where your ideas matter, your growth is supported, and your work can make a meaningful difference.

Our Core Values guide the choices we make and the way we work, 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.

Ready to bring your ideas, experience, and passion to work that matters? Join us and help shape what’s next in vascular care.

Employment with Endologix LLC: Candidates applying for this position are applying for employment with Endologix LLC, which operates as is a Rhevera Medical company. Candidates for this role will not be employed, or jointly employed, by Rhevera Medical Holdings, LLC.

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.

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.

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.

WHAT 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:

• 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

OUR COMMITMENT TO EQUAL OPPORTUNITY AND VETERAN INCLUSION:

Endologix LLC, which operates as a Rhevera Medical company, is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. As a federal contractor, Endologix LLC is committed to taking affirmative action to recruit, employ, and advance in employment qualified individuals with disabilities and protected veterans.