Senior Design Assurance Engineer, Medical Devices

Endologix LLC; Minneapolis (MN); Sur place; USD 110 000 - 128 000; Plein temps

Avantages offerts par ce poste

Base salary and comprehensive benefits

Discretionary bonus

Equity participation

401(k) with company match

Healthcare plans

HSAs/FSAs

Paid time off

Résumé du poste

Endologix LLC is seeking a Sr. Design Assurance Engineer to join our mission-driven Quality team in Minnesota. The role focuses on design control, V&V, and risk management across our vascular device programs, with hands-on ownership from day one.

You will collaborate with R&D, Regulatory, and Manufacturing to ensure patient safety, regulatory compliance, and high-quality product development at our Eden Prairie site.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3–5 years of medical device design quality assurance experience.
• Experience with catheter-based or vascular devices is a plus.
• Exposure to Class III devices and PMA pathways is helpful but not required.
• Strong knowledge of design controls, risk management, and regulatory compliance.

Responsabilités

• Execute design control activities for assigned development programs in compliance with ISO 13485 and 21 CFR Part 820.
• Align design inputs, outputs, and verification/validation activities to ensure patient safety and regulatory compliance.
• Develop and document V&V protocols and reports; support design transfer to manufacturing.
• Maintain design history files and audit-ready documentation.

Connaissances

Design controls

QMSR (21 CFR Part 820)

ISO 13485

ISO 14971

Verification & Validation

Regulatory compliance

Cross-functional collaboration

Documentation

Formation

Bachelor’s degree in Engineering, Life Sciences, or related field

Description du poste

Endologix LLC is seeking a Sr. Design Assurance Engineer to join our mission-driven Quality team in Minnesota. The role focuses on design control, V&V, and risk management across our vascular device programs, with hands-on ownership from day one.

You will collaborate with R&D, Regulatory, and Manufacturing to ensure patient safety, regulatory compliance, and high-quality product development at our Eden Prairie site.