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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr. Design Assurance Engineer - **Company:** Endologix - **Location:** Minneapolis, MN, United States - **Experience:** Expert - **Salary:** $110,000.0 - $127,500.0 - **Contract:** Permanent contract - **Skills:** Data Driven Tests, Verification and Validation (Software), Technical Data Management Systems - **Published:** August 12, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=395538c472160035 ## About the Role * Bachelor's degree in Engineering, Life Sciences, or related field, or equivalent 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. ## Description 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. 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. ## Related Videos - [User 1st! Technology 2nd! 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