Senior Design Assurance Engineer, Medical Devices

Endologix; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Endologix seeks a Sr. Design Assurance Engineer to join the Quality team at our Eden Prairie, MN site. You will own design control, V&V, and risk management activities across DVT and new product development to ensure safety, quality, and regulatory compliance.

You’ll work hands-on from day one, collaborating with R&D and manufacturing partners to embed quality into daily design practices and support successful product commercialization in vascular health.

Qualifications

• Experience executing design control per ISO 13485:2016.
• Experience with V&V planning, execution, and documentation.
• Strong understanding of 21 CFR Part 820 and QMS requirements.

Responsibilities

• Execute design control activities for product development programs.
• Develop, execute, and document V&V protocols and reports.
• Maintain design history files and related documentation for audit-readiness.
• Support design transfer activities to manufacturing processes.
• Collaborate with R&D and cross-functional teams to embed quality into development.

Skills

Design control

Regulatory compliance

Quality systems

Cross-functional collaboration

Job description

Endologix seeks a Sr. Design Assurance Engineer to join the Quality team at our Eden Prairie, MN site. You will own design control, V&V, and risk management activities across DVT and new product development to ensure safety, quality, and regulatory compliance.

You’ll work hands-on from day one, collaborating with R&D and manufacturing partners to embed quality into daily design practices and support successful product commercialization in vascular health.