Senior Design Assurance Engineer – MedTech V&V & Risk

careersus-endologix; Minneapolis (MN); On-site; USD 110,000 - 128,000; Full time

Benefits offered by this job

Competitive pay

Equity participation

Health insurance

401(k) match

Job summary

Endologix is seeking a Sr. Design Assurance Engineer at our Eden Prairie, MN site to lead design control, verification, validation, and risk management for vascular devices. This hands-on role interfaces with R&D, Regulatory, and Manufacturing to ensure patient safety and regulatory compliance.

Ideal candidates bring 3–5 years in medical device QA or design, knowledge of ISO 13485 and ISO 14971, and experience with V&V protocols in a fast-growth environment. Competitive pay and benefits offered.

Qualifications

• Experience with design controls and risk management per ISO 14971.
• Experience with catheter-based or vascular devices is a plus.
• Exposure to Class III devices and PMA pathways is helpful but not required.

Responsibilities

• Execute design assurance activities across product development programs ensuring compliance with ISO 13485:2016, QMSR (21 CFR Part 820), and applicable regulatory requirements.
• Support alignment between design inputs, outputs and verification/validation activities.
• Develop, execute, and document V&V protocols and reports per established strategies.

Skills

Design controls

ISO 13485

ISO 14971

Regulatory compliance

V&V protocols

Cross-functional

Communication

Self-directed

Education

Bachelor's degree in Engineering

Job description

Endologix is seeking a Sr. Design Assurance Engineer at our Eden Prairie, MN site to lead design control, verification, validation, and risk management for vascular devices. This hands-on role interfaces with R&D, Regulatory, and Manufacturing to ensure patient safety and regulatory compliance.

Ideal candidates bring 3–5 years in medical device QA or design, knowledge of ISO 13485 and ISO 14971, and experience with V&V protocols in a fast-growth environment. Competitive pay and benefits offered.